{ "FullStudy":{ "Rank":218214, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511250", "OrgStudyIdInfo":{ "OrgStudyId":"INV-DEN-203" }, "Organization":{ "OrgFullName":"Takeda", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years", "OfficialTitle":"A Double-Blind, Randomized, Placebo-Controlled, Age Descending and Expansion Phase 2 Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years" }, "StatusModule":{ "StatusVerifiedDate":"July 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 16, 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 1, 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 15, 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"November 16, 2011", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"November 20, 2017", "ResultsFirstSubmitQCDate":"February 27, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 27, 2018", "ResultsFirstPostDateType":"Actual" }, "DispFirstSubmitDate":"November 29, 2016", "DispFirstSubmitQCDate":"November 29, 2016", "DispFirstPostDateStruct":{ "DispFirstPostDate":"November 30, 2016", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 16, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 18, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Takeda", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes", "IsFDARegulatedDrug":"Yes", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine (TDV) (previously DENVax) administered subcutaneously in healthy adults and children. In addition the antibody response to the four dengue virus serotypes will be evaluated.", "DetailedDescription":"The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to assess safety and immunogenicity in healthy adults and children living in dengue endemic countries.\n\nThe study enrolled 360 healthy participants. The study was conducted in 2 parts, Part 1 - age descending and and Part 2 - expansion - ages 1.5-11 years. Participants were allocated to one of the four age cohorts in Part 1 (21 to 45 years, 12 to 20 years, 6 to 11 years, and 1.5 to 5 years) and expansion age cohort 1.5-11 years in Part 2. Participants were randomized in 2:1 ratio and in 3: 1 ratio in Part 1 and 2 respectively to receive:\n\nTDV 0.5 mL SC injection\nPlacebo (inactive solution) - this is a solution that looks like the study drug but has no active ingredient\n\nThis multi-center trial was conducted worldwide. The overall time to participate in this study was up to 37 months (including screening period). Participants made multiple visits to the clinic including a final visit at Day 1080." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Healthy" ] }, "KeywordList":{ "Keyword":[ "Normal healthy adults and children", "Safety and tolerability", "Active vaccine", "Placebo", "Dengue virus vaccine", "Immune response" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"360", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Part I: TDV 21 to 45 Years (yrs)", "ArmGroupType":"Experimental", "ArmGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: TDV" ] } },{ "ArmGroupLabel":"Part I: Placebo 21 to 45 yrs", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Placebo" ] } },{ "ArmGroupLabel":"Part I: TDV 12 to 20 yrs", "ArmGroupType":"Experimental", "ArmGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: TDV" ] } },{ "ArmGroupLabel":"Part I: Placebo 12 to 20 yrs", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Placebo" ] } },{ "ArmGroupLabel":"Part I: TDV 6 to 11 yrs", "ArmGroupType":"Experimental", "ArmGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: TDV" ] } },{ "ArmGroupLabel":"Part I: Placebo 6 to 11 yrs", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Placebo" ] } },{ "ArmGroupLabel":"Part I: TDV 1.5 to 5 yrs", "ArmGroupType":"Experimental", "ArmGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: TDV" ] } },{ "ArmGroupLabel":"Part I: Placebo 1.5 to 5 yrs", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Placebo" ] } },{ "ArmGroupLabel":"Part II: TDV 1.5 to 11 yrs", "ArmGroupType":"Experimental", "ArmGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: TDV" ] } },{ "ArmGroupLabel":"Part II: Placebo 1.5 to 11 yrs", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"TDV", "InterventionDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Part I: TDV 1.5 to 5 yrs", "Part I: TDV 12 to 20 yrs", "Part I: TDV 21 to 45 Years (yrs)", "Part I: TDV 6 to 11 yrs", "Part II: TDV 1.5 to 11 yrs" ] } },{ "InterventionType":"Biological", "InterventionName":"Placebo", "InterventionDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Part I: Placebo 1.5 to 5 yrs", "Part I: Placebo 12 to 20 yrs", "Part I: Placebo 21 to 45 yrs", "Part I: Placebo 6 to 11 yrs", "Part II: Placebo 1.5 to 11 yrs" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity", "PrimaryOutcomeDescription":"Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).", "PrimaryOutcomeTimeFrame":"Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)" },{ "PrimaryOutcomeMeasure":"Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity", "PrimaryOutcomeDescription":"Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).", "PrimaryOutcomeTimeFrame":"Within 28 days after either of the vaccination given on Day 0 or 90 (Day 28 for first vaccination, Day 118 for second vaccination)" },{ "PrimaryOutcomeMeasure":"Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity", "PrimaryOutcomeDescription":"Solicited systemic AEs (headache, muscle pain [myalgia], joint pain [arthralgia], eye pain, sensitivity to light [photophobia], tiredness [fatigue], body rash, nausea, were recorded in the participant's-diary along with vomiting [number of times]), and body temperature). Diary-recorded severity grades were based on the Common Terminology Criteria for Adverse Events (CTCAE). Severity grades were: Mild (Grade 1): transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities. The CTCAE severity grades for fever and vomiting were derived from the diary-recorded measurements of temperature level and number of episodes, respectively.", "PrimaryOutcomeTimeFrame":"Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)" },{ "PrimaryOutcomeMeasure":"Number of Participants With Any Solicited AE Following Either Vaccination Dose", "PrimaryOutcomeDescription":"An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited local injection site reactions included pain, itching, erythema, edema and solicited systemic AEs include myalgia, arthralgia, eye pain, photophobia, fatigue, body rash, nausea, vomiting, and fever.", "PrimaryOutcomeTimeFrame":"Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)" },{ "PrimaryOutcomeMeasure":"Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity", "PrimaryOutcomeDescription":"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The severity of all unsolicited AEs was evaluated by the Investigator (using the Common Terminology Criteria for Adverse Events [CTCAE] v4.03) as follows. Mild (Grade 1): Transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): Marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities.", "PrimaryOutcomeTimeFrame":"Unsolicited AEs were collected within 28 days of all vaccinations. Serious AEs were collected throughout the study up to Day 1080" },{ "PrimaryOutcomeMeasure":"Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120", "PrimaryOutcomeDescription":"Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 for any serotype and seronegative was defined as titre value of less than (<) 10 for all 4 serotypes. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.", "PrimaryOutcomeTimeFrame":"30 days after second vaccination (Day 120)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination", "SecondaryOutcomeDescription":"Vaccine viremia was assessed for each of the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4 for Part-1. Vaccine viral ribonucleic acid (RNA) was detected by a quantitative reverse transcription-polymerase chain reaction (qRT-PCR) assay.", "SecondaryOutcomeTimeFrame":"Days 0, 7, 14, 90, 97, and 104" },{ "SecondaryOutcomeMeasure":"Part I: Duration of Vaccine Viremia", "SecondaryOutcomeTimeFrame":"Days 0, 7, 14, 90, 97, and 104" },{ "SecondaryOutcomeMeasure":"Part I: Titers of Vaccine Viremia", "SecondaryOutcomeTimeFrame":"Days 0, 7, 14, 90, 97, and 104" },{ "SecondaryOutcomeMeasure":"Seropositivity Rate to Each of the Four Dengue Serotypes", "SecondaryOutcomeDescription":"Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 and seronegative was defined as titre value of less than (<) 10. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.", "SecondaryOutcomeTimeFrame":"Day 28 and Day 90 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1" },{ "SecondaryOutcomeMeasure":"Seroconversion Rate to Each of the Four Dengue Serotypes", "SecondaryOutcomeDescription":"Seroconversion rate was defined as the percentage of participants with microneutralization test 50% (MNT50) titer ≥10 or, if the titer on Day 0 was ≥10, a 4-fold rise in antibody titer.", "SecondaryOutcomeTimeFrame":"Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1" },{ "SecondaryOutcomeMeasure":"Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes", "SecondaryOutcomeDescription":"GMTs were assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, and TDV-4.", "SecondaryOutcomeTimeFrame":"Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1" },{ "SecondaryOutcomeMeasure":"Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes", "SecondaryOutcomeTimeFrame":"Day 28 and Day 90 (Parts 1 and 2) and Days 120, 180, 360, 720 and 1080 in Part 1" },{ "SecondaryOutcomeMeasure":"Number of Participants With Confirmed Dengue Fever", "SecondaryOutcomeDescription":"Dengue fever was assessed in participants who had 3 consecutive days of fever >38°C and tested positive for dengue virus by polymerase chain reaction (PCR) analysis.", "SecondaryOutcomeTimeFrame":"Day 1 to Day 1080" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nIn good health as determined by medical history, physical examination including height and weight\nNormal safety laboratory values at screening\nNegative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies & Hepatitis B surface antigen\nFemales negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception\nWeight: Within 1.3 times of the upper limit of local normal age-adjusted body mass index (BMI)\n\nExclusion Criteria:\n\nFor participants ≥12 years, clinically significant electrocardiogram (ECG) findings\nHistory of significant dermatologic (skin) disease within last 6 months\nHistory of diabetes mellitus\nHistory of thymic pathology, thymectomy, myasthenia or any immunodeficiency\nHistory of recurring headaches or migraines\nHypersensitivity to any vaccine\nFor participants ≥12 years, positive urine screen for cocaine, amphetamines, opiates, or cannabinoids\nHistory of alcohol abuse\nPregnant or lactating female", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Months", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Medical Director Clinical Science", "OverallOfficialAffiliation":"Takeda", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Program For The Study and Control of Tropical Diseases", "LocationCity":"Medellin", "LocationCountry":"Colombia" },{ "LocationFacility":"Ponce School of Medicine, CAIMED Center", "LocationCity":"Ponce", "LocationZip":"716", "LocationCountry":"Puerto Rico" },{ "LocationFacility":"University of Puerto Rico School of Medicine", "LocationCity":"San Juan", "LocationZip":"00935", "LocationCountry":"Puerto Rico" },{ "LocationFacility":"Latin Clinical Trial Center", "LocationCity":"San Juan", "LocationZip":"909", "LocationCountry":"Puerto Rico" },{ "LocationFacility":"National University Hospital", "LocationCity":"Singapore", "LocationZip":"119228", "LocationCountry":"Singapore" },{ "LocationFacility":"Changi General Hospital", "LocationCity":"Singapore", "LocationZip":"529889", "LocationCountry":"Singapore" },{ "LocationFacility":"Faculty of Tropical Medicine, Mahidol University", "LocationCity":"Bangkok", "LocationState":"Krung Thep Maha Nakhon", "LocationZip":"10270", "LocationCountry":"Thailand" },{ "LocationFacility":"Phramongkutklao Hospital", "LocationCity":"Bangkok", "LocationState":"Krung Thep Maha Nakhon", "LocationZip":"10400", "LocationCountry":"Thailand" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"30783676", "ReferenceType":"derived", "ReferenceCitation":"Sharma M, Glasner DR, Watkins H, Puerta-Guardo H, Kassa Y, Egan MA, Dean H, Harris E. Magnitude and Functionality of the NS1-Specific Antibody Response Elicited by a Live-Attenuated Tetravalent Dengue Vaccine Candidate. J Infect Dis. 2020 Mar 2;221(6):867-877. doi: 10.1093/infdis/jiz081." },{ "ReferencePMID":"26384447", "ReferenceType":"derived", "ReferenceCitation":"Rupp R, Luckasen GJ, Kirstein JL, Osorio JE, Santangelo JD, Raanan M, Smith MK, Wallace D, Gordon GS, Stinchcomb DT. Safety and immunogenicity of different doses and schedules of a live attenuated tetravalent dengue vaccine (TDV) in healthy adults: A Phase 1b randomized study. Vaccine. 2015 Nov 17;33(46):6351-9. doi: 10.1016/j.vaccine.2015.09.008. Epub 2015 Sep 15." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Healthy participants were enrolled in the 2-part study to receive 0.5 mL tetravalent dengue vaccine (TDV) or placebo in 1 of 4 groups for Part I: 21-45 years, 12-20 years, 6-11 years, 1.5-5 years, and in 1 group for Part II: 1.5-11 years. Part II started after all subjects in Part 1 were enrolled.", "FlowRecruitmentDetails":"Participants took part in the study at 8 investigative sites in Puerto Rico, Colombia, Singapore and Thailand from 16 November 2011 to 15 April 2016.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Part I: TDV 21 to 45 Years", "FlowGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Part I: Placebo 21 to 45 Years", "FlowGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Part I: TDV 12 to 20 Years", "FlowGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Part I: Placebo 12 to 20 Years", "FlowGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "FlowGroupId":"FG004", "FlowGroupTitle":"Part I: TDV 6 to 11 Years", "FlowGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "FlowGroupId":"FG005", "FlowGroupTitle":"Part I: Placebo 6 to 11 Years", "FlowGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "FlowGroupId":"FG006", "FlowGroupTitle":"Part I: TDV 1.5 to 5 Years", "FlowGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "FlowGroupId":"FG007", "FlowGroupTitle":"Part I: Placebo 1.5 to 5 Years", "FlowGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "FlowGroupId":"FG008", "FlowGroupTitle":"Part II: TDV 1.5 to 11 Years", "FlowGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "FlowGroupId":"FG009", "FlowGroupTitle":"Part II: Placebo 1.5 to 11 Years", "FlowGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"24" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"22" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"21" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"17" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"23" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"13" },{ "FlowAchievementGroupId":"FG008", "FlowAchievementNumSubjects":"159" },{ "FlowAchievementGroupId":"FG009", "FlowAchievementNumSubjects":"53" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"15" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"18" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"11" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"21" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"17" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"21" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG008", "FlowAchievementNumSubjects":"145" },{ "FlowAchievementGroupId":"FG009", "FlowAchievementNumSubjects":"48" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG008", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG009", "FlowAchievementNumSubjects":"5" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal of Consent", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG008", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG009", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Sponsor/Investigator Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG008", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG009", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"7" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG008", "FlowReasonNumSubjects":"13" },{ "FlowReasonGroupId":"FG009", "FlowReasonNumSubjects":"5" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG008", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG009", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"The full analysis set (FAS) included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Part I: TDV 21 to 45 Years", "BaselineGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Part I: Placebo 21 to 45 Years", "BaselineGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Part I: TDV 12 to 20 Years", "BaselineGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Part I: Placebo 12 to 20 Years", "BaselineGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Part I: TDV 6 to 11 Years", "BaselineGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "BaselineGroupId":"BG005", "BaselineGroupTitle":"Part I: Placebo 6 to 11 Years", "BaselineGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "BaselineGroupId":"BG006", "BaselineGroupTitle":"Part I: TDV 1.5 to 5 Years", "BaselineGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "BaselineGroupId":"BG007", "BaselineGroupTitle":"Part I: Placebo 1.5 to 5 Years", "BaselineGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "BaselineGroupId":"BG008", "BaselineGroupTitle":"Part II: TDV 1.5 to 11 Years", "BaselineGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "BaselineGroupId":"BG009", "BaselineGroupTitle":"Part II: Placebo 1.5 to 11 Years", "BaselineGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "BaselineGroupId":"BG010", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"24" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"14" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"22" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"14" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"21" },{ "BaselineDenomCountGroupId":"BG005", "BaselineDenomCountValue":"17" },{ "BaselineDenomCountGroupId":"BG006", "BaselineDenomCountValue":"23" },{ "BaselineDenomCountGroupId":"BG007", "BaselineDenomCountValue":"13" },{ "BaselineDenomCountGroupId":"BG008", "BaselineDenomCountValue":"159" },{ "BaselineDenomCountGroupId":"BG009", "BaselineDenomCountValue":"53" },{ "BaselineDenomCountGroupId":"BG010", "BaselineDenomCountValue":"360" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"29.2", "BaselineMeasurementLowerLimit":"21.0", "BaselineMeasurementUpperLimit":"45.0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"30.1", "BaselineMeasurementLowerLimit":"21.0", "BaselineMeasurementUpperLimit":"40.0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"15.5", "BaselineMeasurementLowerLimit":"12.0", "BaselineMeasurementUpperLimit":"19.0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"16.8", "BaselineMeasurementLowerLimit":"12.0", "BaselineMeasurementUpperLimit":"20.0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"8.4", "BaselineMeasurementLowerLimit":"6.0", "BaselineMeasurementUpperLimit":"11.0" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"7.8", "BaselineMeasurementLowerLimit":"6.0", "BaselineMeasurementUpperLimit":"11.0" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"3.3", "BaselineMeasurementLowerLimit":"1.5", "BaselineMeasurementUpperLimit":"5.0" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"3.5", "BaselineMeasurementLowerLimit":"2.3", "BaselineMeasurementUpperLimit":"5.0" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"6.6", "BaselineMeasurementLowerLimit":"1.6", "BaselineMeasurementUpperLimit":"11.0" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"6.8", "BaselineMeasurementLowerLimit":"2.1", "BaselineMeasurementUpperLimit":"11.0" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"9.8", "BaselineMeasurementLowerLimit":"1.5", "BaselineMeasurementUpperLimit":"45.0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"88" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"172" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"71" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"34" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"188" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Asian", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"77" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"24" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"177" } ] } } ] } },{ "BaselineClassTitle":"Hispanic or Latino", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"79" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"27" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"175" } ] } } ] } },{ "BaselineClassTitle":"White", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"3" } ] } } ] } },{ "BaselineClassTitle":"Black or African American", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"5" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Seropositive to any Serotype at Day 0", "BaselineMeasureDescription":"Seropositivity is defined as a reciprocal neutralizing titer measured by a microneutralizing test 50% (MNT50) greater or equal to (≥)10.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Seropositive to any Serotype=No", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"93" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"24" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"186" } ] } } ] } },{ "BaselineClassTitle":"Seropositive to any Serotype=Yes", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"66" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"174" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Height", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"meters (m)", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1.68", "BaselineMeasurementLowerLimit":"1.57", "BaselineMeasurementUpperLimit":"1.82" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1.65", "BaselineMeasurementLowerLimit":"1.53", "BaselineMeasurementUpperLimit":"1.87" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1.58", "BaselineMeasurementLowerLimit":"1.38", "BaselineMeasurementUpperLimit":"1.72" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"1.60", "BaselineMeasurementLowerLimit":"1.41", "BaselineMeasurementUpperLimit":"1.73" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"1.29", "BaselineMeasurementLowerLimit":"1.08", "BaselineMeasurementUpperLimit":"1.52" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"1.27", "BaselineMeasurementLowerLimit":"1.13", "BaselineMeasurementUpperLimit":"1.42" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"0.98", "BaselineMeasurementLowerLimit":"0.83", "BaselineMeasurementUpperLimit":"1.13" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"0.99", "BaselineMeasurementLowerLimit":"0.90", "BaselineMeasurementUpperLimit":"1.06" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"1.20", "BaselineMeasurementLowerLimit":"0.77", "BaselineMeasurementUpperLimit":"1.62" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"1.22", "BaselineMeasurementLowerLimit":"0.83", "BaselineMeasurementUpperLimit":"1.63" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"1.28", "BaselineMeasurementLowerLimit":"0.77", "BaselineMeasurementUpperLimit":"1.87" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Weight", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"kilograms (kg)", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"81.6", "BaselineMeasurementLowerLimit":"41.4", "BaselineMeasurementUpperLimit":"115.1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"80.2", "BaselineMeasurementLowerLimit":"56.3", "BaselineMeasurementUpperLimit":"120.4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"57.0", "BaselineMeasurementLowerLimit":"28.6", "BaselineMeasurementUpperLimit":"93.4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"59.5", "BaselineMeasurementLowerLimit":"48.6", "BaselineMeasurementUpperLimit":"89.9" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"31.2", "BaselineMeasurementLowerLimit":"18.5", "BaselineMeasurementUpperLimit":"51.2" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"27.0", "BaselineMeasurementLowerLimit":"20.3", "BaselineMeasurementUpperLimit":"37.5" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"15.1", "BaselineMeasurementLowerLimit":"10.3", "BaselineMeasurementUpperLimit":"22.2" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"16.5", "BaselineMeasurementLowerLimit":"13.3", "BaselineMeasurementUpperLimit":"20.8" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"25.7", "BaselineMeasurementLowerLimit":"10.4", "BaselineMeasurementUpperLimit":"61.0" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"26.7", "BaselineMeasurementLowerLimit":"10.6", "BaselineMeasurementUpperLimit":"53.2" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"34.3", "BaselineMeasurementLowerLimit":"10.3", "BaselineMeasurementUpperLimit":"120.4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Body Mass Index (BMI)", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"kg/m^2", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"28.81", "BaselineMeasurementLowerLimit":"14.70", "BaselineMeasurementUpperLimit":"41.30" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"29.05", "BaselineMeasurementLowerLimit":"21.30", "BaselineMeasurementUpperLimit":"38.70" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"22.60", "BaselineMeasurementLowerLimit":"15.00", "BaselineMeasurementUpperLimit":"33.60" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"23.09", "BaselineMeasurementLowerLimit":"18.60", "BaselineMeasurementUpperLimit":"31.50" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"18.38", "BaselineMeasurementLowerLimit":"12.90", "BaselineMeasurementUpperLimit":"28.80" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"16.56", "BaselineMeasurementLowerLimit":"14.20", "BaselineMeasurementUpperLimit":"20.60" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"15.63", "BaselineMeasurementLowerLimit":"12.50", "BaselineMeasurementUpperLimit":"19.00" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"16.95", "BaselineMeasurementLowerLimit":"13.20", "BaselineMeasurementUpperLimit":"20.40" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"17.02", "BaselineMeasurementLowerLimit":"12.10", "BaselineMeasurementUpperLimit":"30.10" },{ "BaselineMeasurementGroupId":"BG009", "BaselineMeasurementValue":"17.08", "BaselineMeasurementLowerLimit":"13.20", "BaselineMeasurementUpperLimit":"24.30" },{ "BaselineMeasurementGroupId":"BG010", "BaselineMeasurementValue":"18.83", "BaselineMeasurementLowerLimit":"12.10", "BaselineMeasurementUpperLimit":"41.30" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity", "OutcomeMeasureDescription":"Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).", "OutcomeMeasurePopulationDescription":"The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Pain, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"56" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Pain, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"41" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Pain, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Pain, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Itching, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"26" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Itching, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"19" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Itching, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Itching, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Erythema, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"24" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Erythema, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"21" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Erythema, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Erythema, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Edema, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"13" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Edema, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Edema, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Edema, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity", "OutcomeMeasureDescription":"Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).", "OutcomeMeasurePopulationDescription":"The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Within 28 days after either of the vaccination given on Day 0 or 90 (Day 28 for first vaccination, Day 118 for second vaccination)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Pain, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"33" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"14" } ] } } ] } },{ "OutcomeClassTitle":"Pain, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"28" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"13" } ] } } ] } },{ "OutcomeClassTitle":"Pain, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Itching, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Itching, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Erythema, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Edema, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity", "OutcomeMeasureDescription":"Solicited systemic AEs (headache, muscle pain [myalgia], joint pain [arthralgia], eye pain, sensitivity to light [photophobia], tiredness [fatigue], body rash, nausea, were recorded in the participant's-diary along with vomiting [number of times]), and body temperature). Diary-recorded severity grades were based on the Common Terminology Criteria for Adverse Events (CTCAE). Severity grades were: Mild (Grade 1): transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities. The CTCAE severity grades for fever and vomiting were derived from the diary-recorded measurements of temperature level and number of episodes, respectively.", "OutcomeMeasurePopulationDescription":"The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Fever, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"33" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"9" } ] } } ] } },{ "OutcomeClassTitle":"Fever, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"27" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Fever, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Fever, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Headache, Any Grade", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"46" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"12" } ] } } ] } },{ "OutcomeClassTitle":"Headache, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"30" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Headache, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Headache, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Myalgia, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"30" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Myalgia, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"21" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Myalgia, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Myalgia, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Arthralgia, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Arthralgia, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Arthralgia, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Arthralgia, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Eye Pain, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Eye Pain, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Eye Pain, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Eye Pain, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Photophobia, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Photophobia, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Photophobia, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Photophobia, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Fatigue, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"29" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"10" } ] } } ] } },{ "OutcomeClassTitle":"Fatigue, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"19" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Fatigue, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Fatigue, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Body rash, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Body rash, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Body rash, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Body rash, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Nausea, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"22" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Nausea, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Nausea, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Nausea, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Vomiting, Any Severity", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"18" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Vomiting, Grade 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Vomiting, Grade 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Vomiting, Grade 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With Any Solicited AE Following Either Vaccination Dose", "OutcomeMeasureDescription":"An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited local injection site reactions included pain, itching, erythema, edema and solicited systemic AEs include myalgia, arthralgia, eye pain, photophobia, fatigue, body rash, nausea, vomiting, and fever.", "OutcomeMeasurePopulationDescription":"The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"110" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"28" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity", "OutcomeMeasureDescription":"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The severity of all unsolicited AEs was evaluated by the Investigator (using the Common Terminology Criteria for Adverse Events [CTCAE] v4.03) as follows. Mild (Grade 1): Transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): Marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities.", "OutcomeMeasurePopulationDescription":"The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Unsolicited AEs were collected within 28 days of all vaccinations. Serious AEs were collected throughout the study up to Day 1080", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"At least one unsolicited AE", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"101" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"37" } ] } } ] } },{ "OutcomeClassTitle":"Unsolicited AEs by worst severity, Mild", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"13" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"72" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"31" } ] } } ] } },{ "OutcomeClassTitle":"Unsolicited AEs by worst severity, Moderate", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"25" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Unsolicited AEs by worst severity, Severe", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120", "OutcomeMeasureDescription":"Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 for any serotype and seronegative was defined as titre value of less than (<) 10 for all 4 serotypes. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample has been received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"30 days after second vaccination (Day 120)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"11" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"156" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"TDV-1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"92.3", "OutcomeMeasurementLowerLimit":"64", "OutcomeMeasurementUpperLimit":"99.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"97.7", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"43.4", "OutcomeMeasurementLowerLimit":"29.8", "OutcomeMeasurementUpperLimit":"57.7" } ] } } ] } },{ "OutcomeClassTitle":"TDV-2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"95.5", "OutcomeMeasurementLowerLimit":"77.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"97.7", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"35.8", "OutcomeMeasurementLowerLimit":"23.1", "OutcomeMeasurementUpperLimit":"50.2" } ] } } ] } },{ "OutcomeClassTitle":"TDV-3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"75.3", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"29.4", "OutcomeMeasurementLowerLimit":"10.3", "OutcomeMeasurementUpperLimit":"56" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"99.4", "OutcomeMeasurementLowerLimit":"96.5", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"35.8", "OutcomeMeasurementLowerLimit":"23.1", "OutcomeMeasurementUpperLimit":"50.2" } ] } } ] } },{ "OutcomeClassTitle":"TDV-4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"90.9", "OutcomeMeasurementLowerLimit":"70.8", "OutcomeMeasurementUpperLimit":"98.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"61.5", "OutcomeMeasurementLowerLimit":"31.6", "OutcomeMeasurementUpperLimit":"86.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"72.7", "OutcomeMeasurementLowerLimit":"49.8", "OutcomeMeasurementUpperLimit":"89.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"71.4", "OutcomeMeasurementLowerLimit":"41.9", "OutcomeMeasurementUpperLimit":"91.6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"63.7", "OutcomeMeasurementUpperLimit":"97.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"29.4", "OutcomeMeasurementLowerLimit":"10.3", "OutcomeMeasurementUpperLimit":"56.0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"94.9", "OutcomeMeasurementLowerLimit":"90.1", "OutcomeMeasurementUpperLimit":"97.8" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"35.8", "OutcomeMeasurementLowerLimit":"23.1", "OutcomeMeasurementUpperLimit":"50.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination", "OutcomeMeasureDescription":"Vaccine viremia was assessed for each of the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4 for Part-1. Vaccine viral ribonucleic acid (RNA) was detected by a quantitative reverse transcription-polymerase chain reaction (qRT-PCR) assay.", "OutcomeMeasurePopulationDescription":"The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Days 0, 7, 14, 90, 97, and 104", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Day 0, TDV-1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 0, TDV-2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 0, TDV-3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 0, TDV-4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 7, TDV-1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 7, TDV-2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 7, TDV-3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 7, TDV-4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 14, TDV-1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 14, TDV-2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 14, TDV-3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 14, TDV-4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 97, TDV-1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 97, TDV-2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 97, TDV-3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 97, TDV-4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 104, TDV-1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 104, TDV-2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 104, TDV-3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 104, TDV-4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Part I: Duration of Vaccine Viremia", "OutcomeMeasurePopulationDescription":"Due to the very low prevalence of vaccine viremia, there was insufficient data for the estimation of average titer duration of viral RNA within study groups.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"Days 0, 7, 14, 90, 97, and 104", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Part I: Titers of Vaccine Viremia", "OutcomeMeasurePopulationDescription":"Due to the very low prevalence of vaccine viremia, there was insufficient data for the estimation of average titer duration of viral RNA within study groups.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"Days 0, 7, 14, 90, 97, and 104", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Seropositivity Rate to Each of the Four Dengue Serotypes", "OutcomeMeasureDescription":"Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 and seronegative was defined as titre value of less than (<) 10. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Day 28 and Day 90 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Day 28, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"85.8", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"92.3", "OutcomeMeasurementLowerLimit":"64.0", "OutcomeMeasurementUpperLimit":"99.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"86.4", "OutcomeMeasurementLowerLimit":"65.1", "OutcomeMeasurementUpperLimit":"97.1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"85.2", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"7.7", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"36.0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"97.7", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"41.5", "OutcomeMeasurementLowerLimit":"28.1", "OutcomeMeasurementUpperLimit":"55.9" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"85.8", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"92.3", "OutcomeMeasurementLowerLimit":"64.0", "OutcomeMeasurementUpperLimit":"99.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"86.4", "OutcomeMeasurementLowerLimit":"65.1", "OutcomeMeasurementUpperLimit":"97.1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"95.7", "OutcomeMeasurementLowerLimit":"78.1", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"24.7" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"96.8", "OutcomeMeasurementLowerLimit":"92.8", "OutcomeMeasurementUpperLimit":"99.0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"34.0", "OutcomeMeasurementLowerLimit":"21.5", "OutcomeMeasurementUpperLimit":"48.3" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"95.8", "OutcomeMeasurementLowerLimit":"78.9", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"90.9", "OutcomeMeasurementLowerLimit":"70.8", "OutcomeMeasurementUpperLimit":"98.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"92.9", "OutcomeMeasurementLowerLimit":"66.1", "OutcomeMeasurementUpperLimit":"99.8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"17.6", "OutcomeMeasurementLowerLimit":"3.8", "OutcomeMeasurementUpperLimit":"43.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"91.3", "OutcomeMeasurementLowerLimit":"72.0", "OutcomeMeasurementUpperLimit":"98.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"24.7" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"95.6", "OutcomeMeasurementLowerLimit":"91.1", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"39.6", "OutcomeMeasurementLowerLimit":"26.5", "OutcomeMeasurementUpperLimit":"54.0" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"79.2", "OutcomeMeasurementLowerLimit":"57.8", "OutcomeMeasurementUpperLimit":"92.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"76.9", "OutcomeMeasurementLowerLimit":"46.2", "OutcomeMeasurementUpperLimit":"95.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"59.1", "OutcomeMeasurementLowerLimit":"36.4", "OutcomeMeasurementUpperLimit":"79.2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"78.6", "OutcomeMeasurementLowerLimit":"49.2", "OutcomeMeasurementUpperLimit":"95.3" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"63.7", "OutcomeMeasurementUpperLimit":"97.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"11.8", "OutcomeMeasurementLowerLimit":"1.5", "OutcomeMeasurementUpperLimit":"36.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"69.6", "OutcomeMeasurementLowerLimit":"47.1", "OutcomeMeasurementUpperLimit":"86.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"24.7" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"74.1", "OutcomeMeasurementLowerLimit":"66.5", "OutcomeMeasurementUpperLimit":"80.7" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"35.8", "OutcomeMeasurementLowerLimit":"23.1", "OutcomeMeasurementUpperLimit":"50.2" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"85.2", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"92.3", "OutcomeMeasurementLowerLimit":"64.0", "OutcomeMeasurementUpperLimit":"99.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"90.9", "OutcomeMeasurementLowerLimit":"70.8", "OutcomeMeasurementUpperLimit":"98.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"17.6", "OutcomeMeasurementLowerLimit":"3.8", "OutcomeMeasurementUpperLimit":"43.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"95.5", "OutcomeMeasurementLowerLimit":"77.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"99.4", "OutcomeMeasurementLowerLimit":"96.5", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"41.5", "OutcomeMeasurementLowerLimit":"28.1", "OutcomeMeasurementUpperLimit":"55.9" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"85.2", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"90.9", "OutcomeMeasurementLowerLimit":"70.8", "OutcomeMeasurementUpperLimit":"98.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"17.6", "OutcomeMeasurementLowerLimit":"3.8", "OutcomeMeasurementUpperLimit":"43.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"98.7", "OutcomeMeasurementLowerLimit":"95.5", "OutcomeMeasurementUpperLimit":"99.8" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"34.0", "OutcomeMeasurementLowerLimit":"21.5", "OutcomeMeasurementUpperLimit":"48.3" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"95.7", "OutcomeMeasurementLowerLimit":"78.1", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"75.3", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"90.9", "OutcomeMeasurementLowerLimit":"70.8", "OutcomeMeasurementUpperLimit":"98.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"17.6", "OutcomeMeasurementLowerLimit":"3.8", "OutcomeMeasurementUpperLimit":"43.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"81.8", "OutcomeMeasurementLowerLimit":"59.7", "OutcomeMeasurementUpperLimit":"94.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"9.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"41.3" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"89.9", "OutcomeMeasurementLowerLimit":"84.2", "OutcomeMeasurementUpperLimit":"94.1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"34.0", "OutcomeMeasurementLowerLimit":"21.5", "OutcomeMeasurementUpperLimit":"48.3" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"82.6", "OutcomeMeasurementLowerLimit":"61.2", "OutcomeMeasurementUpperLimit":"95.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"69.2", "OutcomeMeasurementLowerLimit":"38.6", "OutcomeMeasurementUpperLimit":"90.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"77.3", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"92.2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"78.6", "OutcomeMeasurementLowerLimit":"49.2", "OutcomeMeasurementUpperLimit":"95.3" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"66.7", "OutcomeMeasurementLowerLimit":"43.0", "OutcomeMeasurementUpperLimit":"85.4" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"11.8", "OutcomeMeasurementLowerLimit":"1.5", "OutcomeMeasurementUpperLimit":"36.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"63.6", "OutcomeMeasurementLowerLimit":"40.7", "OutcomeMeasurementUpperLimit":"82.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"9.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"41.3" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"69.8", "OutcomeMeasurementLowerLimit":"62.0", "OutcomeMeasurementUpperLimit":"76.8" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"35.8", "OutcomeMeasurementLowerLimit":"23.1", "OutcomeMeasurementUpperLimit":"50.2" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", 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"OutcomeMeasurementValue":"91.7", "OutcomeMeasurementLowerLimit":"61.5", "OutcomeMeasurementUpperLimit":"99.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.2", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"83.3", "OutcomeMeasurementLowerLimit":"51.6", "OutcomeMeasurementUpperLimit":"97.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.2", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"91.7", "OutcomeMeasurementLowerLimit":"61.5", "OutcomeMeasurementUpperLimit":"99.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"57.2", "OutcomeMeasurementUpperLimit":"98.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"35.3", "OutcomeMeasurementLowerLimit":"14.2", "OutcomeMeasurementUpperLimit":"61.7" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"95.5", "OutcomeMeasurementLowerLimit":"77.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"9.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"41.3" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { 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"OutcomeMeasurementLowerLimit":"68.3", "OutcomeMeasurementUpperLimit":"98.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"66.7", "OutcomeMeasurementLowerLimit":"34.9", "OutcomeMeasurementUpperLimit":"90.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"76.2", "OutcomeMeasurementLowerLimit":"52.8", "OutcomeMeasurementUpperLimit":"91.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"78.6", "OutcomeMeasurementLowerLimit":"49.2", "OutcomeMeasurementUpperLimit":"95.3" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"81.0", "OutcomeMeasurementLowerLimit":"58.1", "OutcomeMeasurementUpperLimit":"94.6" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"17.6", "OutcomeMeasurementLowerLimit":"3.8", "OutcomeMeasurementUpperLimit":"43.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"77.3", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"92.2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"82.4", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"91.7", "OutcomeMeasurementLowerLimit":"61.5", "OutcomeMeasurementUpperLimit":"99.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"90.5", "OutcomeMeasurementLowerLimit":"69.6", "OutcomeMeasurementUpperLimit":"98.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"29.4", "OutcomeMeasurementLowerLimit":"10.3", "OutcomeMeasurementUpperLimit":"56.0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"9.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"41.3" } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", 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"OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"29.4", "OutcomeMeasurementLowerLimit":"10.3", "OutcomeMeasurementUpperLimit":"56.0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"89.5", "OutcomeMeasurementLowerLimit":"66.9", "OutcomeMeasurementUpperLimit":"98.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"83.3", "OutcomeMeasurementLowerLimit":"51.6", "OutcomeMeasurementUpperLimit":"97.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"81.0", "OutcomeMeasurementLowerLimit":"58.1", "OutcomeMeasurementUpperLimit":"94.6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"29.4", "OutcomeMeasurementLowerLimit":"10.3", "OutcomeMeasurementUpperLimit":"56.0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"95.5", "OutcomeMeasurementLowerLimit":"77.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"84.2", "OutcomeMeasurementLowerLimit":"60.4", "OutcomeMeasurementUpperLimit":"96.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"75.0", "OutcomeMeasurementLowerLimit":"42.8", "OutcomeMeasurementUpperLimit":"94.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"66.7", "OutcomeMeasurementLowerLimit":"43.0", "OutcomeMeasurementUpperLimit":"85.4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"61.9", "OutcomeMeasurementLowerLimit":"38.4", "OutcomeMeasurementUpperLimit":"81.9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"17.6", "OutcomeMeasurementLowerLimit":"3.8", "OutcomeMeasurementUpperLimit":"43.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"63.6", "OutcomeMeasurementLowerLimit":"40.7", "OutcomeMeasurementUpperLimit":"82.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"79.4", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"66.4", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"89.5", "OutcomeMeasurementLowerLimit":"66.9", "OutcomeMeasurementUpperLimit":"98.7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"10.0", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"44.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"79.4", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"88.9", "OutcomeMeasurementLowerLimit":"51.8", "OutcomeMeasurementUpperLimit":"99.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"94.7", "OutcomeMeasurementLowerLimit":"74.0", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"10.0", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"44.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"87.5", "OutcomeMeasurementLowerLimit":"61.7", "OutcomeMeasurementUpperLimit":"98.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"88.9", "OutcomeMeasurementLowerLimit":"51.8", "OutcomeMeasurementUpperLimit":"99.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"68.4", "OutcomeMeasurementLowerLimit":"43.4", "OutcomeMeasurementUpperLimit":"87.4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"71.4", "OutcomeMeasurementLowerLimit":"47.8", "OutcomeMeasurementUpperLimit":"88.7" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"17.6", "OutcomeMeasurementLowerLimit":"3.8", "OutcomeMeasurementUpperLimit":"43.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"90.9", "OutcomeMeasurementLowerLimit":"70.8", "OutcomeMeasurementUpperLimit":"98.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"10.0", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"44.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"81.3", "OutcomeMeasurementLowerLimit":"54.4", "OutcomeMeasurementUpperLimit":"96.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"77.8", "OutcomeMeasurementLowerLimit":"40.0", "OutcomeMeasurementUpperLimit":"97.2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"63.2", "OutcomeMeasurementLowerLimit":"38.4", "OutcomeMeasurementUpperLimit":"83.7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"84.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"98.1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"57.1", "OutcomeMeasurementLowerLimit":"34.0", "OutcomeMeasurementUpperLimit":"78.2" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"72.7", "OutcomeMeasurementLowerLimit":"49.8", "OutcomeMeasurementUpperLimit":"89.3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"10.0", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"44.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"78.2", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"63.1", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"94.4", "OutcomeMeasurementLowerLimit":"72.7", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"81.8", "OutcomeMeasurementLowerLimit":"48.2", "OutcomeMeasurementUpperLimit":"97.7" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"11.1", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"48.2" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"78.2", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"87.5", "OutcomeMeasurementLowerLimit":"47.3", "OutcomeMeasurementUpperLimit":"99.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"81.5", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"81.8", "OutcomeMeasurementLowerLimit":"48.2", "OutcomeMeasurementUpperLimit":"97.7" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"100.0", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"100.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"33.6" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"93.3", "OutcomeMeasurementLowerLimit":"68.1", "OutcomeMeasurementUpperLimit":"99.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"87.5", "OutcomeMeasurementLowerLimit":"47.3", "OutcomeMeasurementUpperLimit":"99.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"77.8", "OutcomeMeasurementLowerLimit":"52.4", "OutcomeMeasurementUpperLimit":"93.6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"81.8", "OutcomeMeasurementLowerLimit":"48.2", "OutcomeMeasurementUpperLimit":"97.7" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"63.7", "OutcomeMeasurementUpperLimit":"97.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"11.1", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"48.2" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"80.0", "OutcomeMeasurementLowerLimit":"51.9", "OutcomeMeasurementUpperLimit":"95.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"87.5", "OutcomeMeasurementLowerLimit":"47.3", "OutcomeMeasurementUpperLimit":"99.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"61.1", "OutcomeMeasurementLowerLimit":"35.7", "OutcomeMeasurementUpperLimit":"82.7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"72.7", "OutcomeMeasurementLowerLimit":"39.0", "OutcomeMeasurementUpperLimit":"94.0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"42.9", "OutcomeMeasurementLowerLimit":"21.8", "OutcomeMeasurementUpperLimit":"66.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"17.6", "OutcomeMeasurementLowerLimit":"3.8", "OutcomeMeasurementUpperLimit":"43.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"47.6", "OutcomeMeasurementLowerLimit":"25.7", "OutcomeMeasurementUpperLimit":"70.2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"11.1", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"48.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Seroconversion Rate to Each of the Four Dengue Serotypes", "OutcomeMeasureDescription":"Seroconversion rate was defined as the percentage of participants with microneutralization test 50% (MNT50) titer ≥10 or, if the titer on Day 0 was ≥10, a 4-fold rise in antibody titer.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Day 28, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"45.8", "OutcomeMeasurementLowerLimit":"25.6", "OutcomeMeasurementUpperLimit":"67.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.7", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"36.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"63.6", "OutcomeMeasurementLowerLimit":"40.7", "OutcomeMeasurementUpperLimit":"82.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"23.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"90.5", "OutcomeMeasurementLowerLimit":"69.6", "OutcomeMeasurementUpperLimit":"98.8" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"5.9", "OutcomeMeasurementLowerLimit":"0.1", "OutcomeMeasurementUpperLimit":"28.7" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"87.0", "OutcomeMeasurementLowerLimit":"66.4", "OutcomeMeasurementUpperLimit":"97.2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"7.7", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"36.0" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"86.1", "OutcomeMeasurementLowerLimit":"79.7", "OutcomeMeasurementUpperLimit":"91.1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"10.1" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"33.3", "OutcomeMeasurementLowerLimit":"15.6", "OutcomeMeasurementUpperLimit":"55.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.4", "OutcomeMeasurementLowerLimit":"1.9", "OutcomeMeasurementUpperLimit":"45.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"59.1", "OutcomeMeasurementLowerLimit":"36.4", "OutcomeMeasurementUpperLimit":"79.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"23.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"63.7", "OutcomeMeasurementUpperLimit":"97.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"11.8", "OutcomeMeasurementLowerLimit":"1.5", "OutcomeMeasurementUpperLimit":"36.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"87.0", "OutcomeMeasurementLowerLimit":"66.4", "OutcomeMeasurementUpperLimit":"97.2" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"24.7" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"86.7", "OutcomeMeasurementLowerLimit":"80.4", "OutcomeMeasurementUpperLimit":"91.6" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"6.7" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"33.3", "OutcomeMeasurementLowerLimit":"15.6", "OutcomeMeasurementUpperLimit":"55.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"24.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"63.6", "OutcomeMeasurementLowerLimit":"40.7", "OutcomeMeasurementUpperLimit":"82.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"33.9" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"90.5", "OutcomeMeasurementLowerLimit":"69.6", "OutcomeMeasurementUpperLimit":"98.8" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"19.5" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"78.3", "OutcomeMeasurementLowerLimit":"56.3", "OutcomeMeasurementUpperLimit":"92.5" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"24.7" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"82.3", "OutcomeMeasurementLowerLimit":"75.4", "OutcomeMeasurementUpperLimit":"87.9" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"10.1" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.8", "OutcomeMeasurementLowerLimit":"7.1", "OutcomeMeasurementUpperLimit":"42.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.4", "OutcomeMeasurementLowerLimit":"1.9", "OutcomeMeasurementUpperLimit":"45.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"31.8", "OutcomeMeasurementLowerLimit":"13.9", "OutcomeMeasurementUpperLimit":"54.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"23.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"71.4", "OutcomeMeasurementLowerLimit":"47.8", "OutcomeMeasurementUpperLimit":"88.7" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"5.9", "OutcomeMeasurementLowerLimit":"0.1", "OutcomeMeasurementUpperLimit":"28.7" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"60.9", "OutcomeMeasurementLowerLimit":"38.5", "OutcomeMeasurementUpperLimit":"80.3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"24.7" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"62.7", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"70.2" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"5.7", "OutcomeMeasurementLowerLimit":"1.2", "OutcomeMeasurementUpperLimit":"15.7" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"39.1", "OutcomeMeasurementLowerLimit":"19.7", "OutcomeMeasurementUpperLimit":"61.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.4", "OutcomeMeasurementLowerLimit":"1.9", "OutcomeMeasurementUpperLimit":"45.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"54.5", "OutcomeMeasurementLowerLimit":"32.2", "OutcomeMeasurementUpperLimit":"75.6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"33.9" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"81.0", "OutcomeMeasurementLowerLimit":"58.1", "OutcomeMeasurementUpperLimit":"94.6" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"19.5" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"81.8", "OutcomeMeasurementLowerLimit":"59.7", "OutcomeMeasurementUpperLimit":"94.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"82.4", "OutcomeMeasurementLowerLimit":"75.6", "OutcomeMeasurementUpperLimit":"88.0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3.8", "OutcomeMeasurementLowerLimit":"0.5", "OutcomeMeasurementUpperLimit":"13.0" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.4", "OutcomeMeasurementLowerLimit":"13.2", "OutcomeMeasurementUpperLimit":"52.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.4", "OutcomeMeasurementLowerLimit":"1.9", "OutcomeMeasurementUpperLimit":"45.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"59.1", "OutcomeMeasurementLowerLimit":"36.4", "OutcomeMeasurementUpperLimit":"79.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"33.9" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"63.7", "OutcomeMeasurementUpperLimit":"97.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"19.5" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"90.9", "OutcomeMeasurementLowerLimit":"70.8", "OutcomeMeasurementUpperLimit":"98.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"86.2", "OutcomeMeasurementLowerLimit":"79.8", "OutcomeMeasurementUpperLimit":"91.1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"10.1" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.4", "OutcomeMeasurementLowerLimit":"13.2", "OutcomeMeasurementUpperLimit":"52.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"23.1", "OutcomeMeasurementLowerLimit":"5.0", "OutcomeMeasurementUpperLimit":"53.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"59.1", "OutcomeMeasurementLowerLimit":"36.4", "OutcomeMeasurementUpperLimit":"79.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"14.3", "OutcomeMeasurementLowerLimit":"1.8", "OutcomeMeasurementUpperLimit":"42.8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"81.0", "OutcomeMeasurementLowerLimit":"58.1", "OutcomeMeasurementUpperLimit":"94.6" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"19.5" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"63.6", "OutcomeMeasurementLowerLimit":"40.7", "OutcomeMeasurementUpperLimit":"82.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"9.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"41.3" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"76.1", "OutcomeMeasurementLowerLimit":"68.7", "OutcomeMeasurementUpperLimit":"82.5" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"6.7" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ 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"OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"54.5", "OutcomeMeasurementLowerLimit":"32.2", "OutcomeMeasurementUpperLimit":"75.6" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"9.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"41.3" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"57.9", "OutcomeMeasurementLowerLimit":"49.8", "OutcomeMeasurementUpperLimit":"65.6" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"5.7", "OutcomeMeasurementLowerLimit":"1.2", "OutcomeMeasurementUpperLimit":"15.7" } ] } } ] } },{ "OutcomeClassTitle":"Day 120, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ 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"OutcomeMeasurementUpperLimit":"23.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"5.9", "OutcomeMeasurementLowerLimit":"0.1", "OutcomeMeasurementUpperLimit":"28.7" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"95.5", "OutcomeMeasurementLowerLimit":"77.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"90.4", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"94.5" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3.8", "OutcomeMeasurementLowerLimit":"0.5", "OutcomeMeasurementUpperLimit":"13.0" } ] } } ] } },{ "OutcomeClassTitle":"Day 120, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"156" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ 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"OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"36.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"45.5", "OutcomeMeasurementLowerLimit":"24.4", "OutcomeMeasurementUpperLimit":"67.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"14.3", "OutcomeMeasurementLowerLimit":"1.8", "OutcomeMeasurementUpperLimit":"42.8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"63.7", "OutcomeMeasurementUpperLimit":"97.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"23.5", "OutcomeMeasurementLowerLimit":"6.8", "OutcomeMeasurementUpperLimit":"49.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"95.5", "OutcomeMeasurementLowerLimit":"77.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"84.0", "OutcomeMeasurementLowerLimit":"77.3", "OutcomeMeasurementUpperLimit":"89.4" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"3.8", "OutcomeMeasurementLowerLimit":"0.5", "OutcomeMeasurementUpperLimit":"13.0" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"50.0", "OutcomeMeasurementLowerLimit":"27.2", "OutcomeMeasurementUpperLimit":"72.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.3", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"38.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"61.9", "OutcomeMeasurementLowerLimit":"38.4", "OutcomeMeasurementUpperLimit":"81.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"23.2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"5.9", "OutcomeMeasurementLowerLimit":"0.1", "OutcomeMeasurementUpperLimit":"28.7" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"90.9", "OutcomeMeasurementLowerLimit":"70.8", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", 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"OutcomeMeasurementValue":"8.3", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"38.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"61.9", "OutcomeMeasurementLowerLimit":"38.4", "OutcomeMeasurementUpperLimit":"81.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"33.9" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementLowerLimit":"76.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"5.9", "OutcomeMeasurementLowerLimit":"0.1", "OutcomeMeasurementUpperLimit":"28.7" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"95.5", "OutcomeMeasurementLowerLimit":"77.2", "OutcomeMeasurementUpperLimit":"99.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"28.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"40.0", "OutcomeMeasurementLowerLimit":"19.1", "OutcomeMeasurementUpperLimit":"63.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.3", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"38.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"61.9", "OutcomeMeasurementLowerLimit":"38.4", "OutcomeMeasurementUpperLimit":"81.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7.1", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"33.9" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"90.5", "OutcomeMeasurementLowerLimit":"69.5", "OutcomeMeasurementUpperLimit":"98.8" },{ "OutcomeMeasurementGroupId":"OG005", 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"OutcomeMeasurementValue":"85.7", "OutcomeMeasurementLowerLimit":"63.7", "OutcomeMeasurementUpperLimit":"97.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"33.6" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"33.3", "OutcomeMeasurementLowerLimit":"11.8", "OutcomeMeasurementUpperLimit":"61.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"36.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"44.4", "OutcomeMeasurementLowerLimit":"21.5", "OutcomeMeasurementUpperLimit":"69.2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"18.2", "OutcomeMeasurementLowerLimit":"2.3", "OutcomeMeasurementUpperLimit":"51.8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"81.0", "OutcomeMeasurementLowerLimit":"58.1", "OutcomeMeasurementUpperLimit":"94.6" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"5.9", "OutcomeMeasurementLowerLimit":"0.1", "OutcomeMeasurementUpperLimit":"28.7" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"90.5", "OutcomeMeasurementLowerLimit":"69.6", "OutcomeMeasurementUpperLimit":"98.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"11.1", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"48.2" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13.3", "OutcomeMeasurementLowerLimit":"1.7", "OutcomeMeasurementUpperLimit":"40.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12.5", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"52.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"27.8", "OutcomeMeasurementLowerLimit":"9.7", "OutcomeMeasurementUpperLimit":"53.5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"18.2", "OutcomeMeasurementLowerLimit":"2.3", "OutcomeMeasurementUpperLimit":"51.8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"33.3", "OutcomeMeasurementLowerLimit":"14.6", "OutcomeMeasurementUpperLimit":"57.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"11.8", "OutcomeMeasurementLowerLimit":"1.5", "OutcomeMeasurementUpperLimit":"36.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"38.1", "OutcomeMeasurementLowerLimit":"18.1", "OutcomeMeasurementUpperLimit":"61.6" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"11.1", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"48.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes", "OutcomeMeasureDescription":"GMTs were assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, and TDV-4.", "OutcomeMeasurePopulationDescription":"The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received. Here \"n\" is the number of participants with microneutralizing (MN) assay samples.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"titer", "OutcomeMeasureTimeFrame":"Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Day 28, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1156.9", "OutcomeMeasurementLowerLimit":"582.0", "OutcomeMeasurementUpperLimit":"2299.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"396.1", "OutcomeMeasurementLowerLimit":"120.6", "OutcomeMeasurementUpperLimit":"1301.2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"919.5", "OutcomeMeasurementLowerLimit":"273.1", "OutcomeMeasurementUpperLimit":"3096.1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"204.9", "OutcomeMeasurementLowerLimit":"59.8", "OutcomeMeasurementUpperLimit":"702.6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"383.7", "OutcomeMeasurementLowerLimit":"178.1", "OutcomeMeasurementUpperLimit":"826.5" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"11.3", "OutcomeMeasurementLowerLimit":"4.4", "OutcomeMeasurementUpperLimit":"29.3" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"395.2", "OutcomeMeasurementLowerLimit":"190.0", "OutcomeMeasurementUpperLimit":"822.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.3", "OutcomeMeasurementLowerLimit":"4.7", "OutcomeMeasurementUpperLimit":"5.9" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"522.2", "OutcomeMeasurementLowerLimit":"396.5", "OutcomeMeasurementUpperLimit":"687.7" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"28.7", "OutcomeMeasurementLowerLimit":"14.8", "OutcomeMeasurementUpperLimit":"55.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2313.9", "OutcomeMeasurementLowerLimit":"1328.1", "OutcomeMeasurementUpperLimit":"4031.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"178.0", "OutcomeMeasurementLowerLimit":"44.4", "OutcomeMeasurementUpperLimit":"712.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1726.6", "OutcomeMeasurementLowerLimit":"539.2", "OutcomeMeasurementUpperLimit":"5528.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"420.2", "OutcomeMeasurementLowerLimit":"116.5", "OutcomeMeasurementUpperLimit":"1515.6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2357.2", "OutcomeMeasurementLowerLimit":"1218.6", "OutcomeMeasurementUpperLimit":"4559.7" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"13.9", "OutcomeMeasurementLowerLimit":"5.0", "OutcomeMeasurementUpperLimit":"38.6" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1134.6", "OutcomeMeasurementLowerLimit":"479.9", "OutcomeMeasurementUpperLimit":"2682.6" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the lower limit of detection (LLOD)." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"1496.5", "OutcomeMeasurementLowerLimit":"1129.1", "OutcomeMeasurementUpperLimit":"1983.4" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"16.4", "OutcomeMeasurementLowerLimit":"9.7", "OutcomeMeasurementUpperLimit":"27.9" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"538.2", "OutcomeMeasurementLowerLimit":"218.3", "OutcomeMeasurementUpperLimit":"1326.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"226.3", "OutcomeMeasurementLowerLimit":"70.1", "OutcomeMeasurementUpperLimit":"730.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"330.2", "OutcomeMeasurementLowerLimit":"94.4", "OutcomeMeasurementUpperLimit":"1155.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"304.5", "OutcomeMeasurementLowerLimit":"83.9", "OutcomeMeasurementUpperLimit":"1105.6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"314.8", "OutcomeMeasurementLowerLimit":"135.3", "OutcomeMeasurementUpperLimit":"732.3" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"8.5", "OutcomeMeasurementLowerLimit":"4.1", "OutcomeMeasurementUpperLimit":"17.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"129.6", "OutcomeMeasurementLowerLimit":"52.9", "OutcomeMeasurementUpperLimit":"317.6" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"206.9", "OutcomeMeasurementLowerLimit":"149.9", "OutcomeMeasurementUpperLimit":"285.7" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"19.4", "OutcomeMeasurementLowerLimit":"11.5", "OutcomeMeasurementUpperLimit":"32.6" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"130.7", "OutcomeMeasurementLowerLimit":"54.3", "OutcomeMeasurementUpperLimit":"314.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"55.1", "OutcomeMeasurementLowerLimit":"15.6", "OutcomeMeasurementUpperLimit":"194.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"56.6", "OutcomeMeasurementLowerLimit":"19.1", "OutcomeMeasurementUpperLimit":"167.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"46.4", "OutcomeMeasurementLowerLimit":"17.6", "OutcomeMeasurementUpperLimit":"122.4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"61.4", "OutcomeMeasurementLowerLimit":"27.1", "OutcomeMeasurementUpperLimit":"139.4" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"7.2", "OutcomeMeasurementLowerLimit":"3.9", "OutcomeMeasurementUpperLimit":"13.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"27.0", "OutcomeMeasurementLowerLimit":"12.5", "OutcomeMeasurementUpperLimit":"58.5" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"45.4", "OutcomeMeasurementLowerLimit":"33.2", "OutcomeMeasurementUpperLimit":"62.0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"11.0", "OutcomeMeasurementLowerLimit":"7.8", "OutcomeMeasurementUpperLimit":"15.6" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"961.3", "OutcomeMeasurementLowerLimit":"413.5", "OutcomeMeasurementUpperLimit":"2235.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"751.0", "OutcomeMeasurementLowerLimit":"227.1", "OutcomeMeasurementUpperLimit":"2483.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"555.4", "OutcomeMeasurementLowerLimit":"156.9", "OutcomeMeasurementUpperLimit":"1966.2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"215.3", "OutcomeMeasurementLowerLimit":"55.4", "OutcomeMeasurementUpperLimit":"836.4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"245.7", "OutcomeMeasurementLowerLimit":"82.2", "OutcomeMeasurementUpperLimit":"734.7" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"10.8", "OutcomeMeasurementLowerLimit":"4.2", "OutcomeMeasurementUpperLimit":"28.3" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"165.1", "OutcomeMeasurementLowerLimit":"69.4", "OutcomeMeasurementUpperLimit":"392.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"324.2", "OutcomeMeasurementLowerLimit":"239.1", "OutcomeMeasurementUpperLimit":"439.6" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"27.9", "OutcomeMeasurementLowerLimit":"14.6", "OutcomeMeasurementUpperLimit":"53.4" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2073.1", "OutcomeMeasurementLowerLimit":"1267.0", "OutcomeMeasurementUpperLimit":"3392.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"320.0", "OutcomeMeasurementLowerLimit":"74.2", "OutcomeMeasurementUpperLimit":"1379.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1146.4", "OutcomeMeasurementLowerLimit":"416.7", "OutcomeMeasurementUpperLimit":"3153.6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"463.9", "OutcomeMeasurementLowerLimit":"120.1", "OutcomeMeasurementUpperLimit":"1792.0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"966.9", "OutcomeMeasurementLowerLimit":"451.8", "OutcomeMeasurementUpperLimit":"2069.2" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"10.0", "OutcomeMeasurementLowerLimit":"4.3", "OutcomeMeasurementUpperLimit":"23.1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"467.0", "OutcomeMeasurementLowerLimit":"205.7", "OutcomeMeasurementUpperLimit":"1060.3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"463.5", "OutcomeMeasurementLowerLimit":"364.0", "OutcomeMeasurementUpperLimit":"590.2" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"15.2", "OutcomeMeasurementLowerLimit":"8.9", "OutcomeMeasurementUpperLimit":"25.9" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"510.5", "OutcomeMeasurementLowerLimit":"218.3", "OutcomeMeasurementUpperLimit":"1194.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"272.7", "OutcomeMeasurementLowerLimit":"86.4", "OutcomeMeasurementUpperLimit":"860.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"193.3", "OutcomeMeasurementLowerLimit":"54.9", "OutcomeMeasurementUpperLimit":"680.7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"336.2", "OutcomeMeasurementLowerLimit":"95.3", "OutcomeMeasurementUpperLimit":"1185.8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"195.0", "OutcomeMeasurementLowerLimit":"73.3", "OutcomeMeasurementUpperLimit":"518.8" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"8.5", "OutcomeMeasurementLowerLimit":"4.4", "OutcomeMeasurementUpperLimit":"16.5" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"66.2", "OutcomeMeasurementLowerLimit":"28.3", "OutcomeMeasurementUpperLimit":"154.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.3", "OutcomeMeasurementLowerLimit":"4.6", "OutcomeMeasurementUpperLimit":"6.1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"139.5", "OutcomeMeasurementLowerLimit":"99.7", "OutcomeMeasurementUpperLimit":"195.1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"17.1", "OutcomeMeasurementLowerLimit":"10.2", "OutcomeMeasurementUpperLimit":"28.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"125.7", "OutcomeMeasurementLowerLimit":"57.7", "OutcomeMeasurementUpperLimit":"274.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"36.0", "OutcomeMeasurementLowerLimit":"13.3", "OutcomeMeasurementUpperLimit":"97.2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"76.3", "OutcomeMeasurementLowerLimit":"29.3", "OutcomeMeasurementUpperLimit":"198.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"69.0", "OutcomeMeasurementLowerLimit":"23.7", "OutcomeMeasurementUpperLimit":"200.4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"31.2", "OutcomeMeasurementLowerLimit":"12.3", "OutcomeMeasurementUpperLimit":"79.3" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"7.5", "OutcomeMeasurementLowerLimit":"4.0", "OutcomeMeasurementUpperLimit":"14.3" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"16.8", "OutcomeMeasurementLowerLimit":"9.3", "OutcomeMeasurementUpperLimit":"30.5" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.3", "OutcomeMeasurementLowerLimit":"4.6", "OutcomeMeasurementUpperLimit":"6.1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"33.7", "OutcomeMeasurementLowerLimit":"25.4", "OutcomeMeasurementUpperLimit":"44.7" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"11.8", "OutcomeMeasurementLowerLimit":"8.2", "OutcomeMeasurementUpperLimit":"16.9" } ] } } ] } },{ "OutcomeClassTitle":"Day 120, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"156" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1240.3", "OutcomeMeasurementLowerLimit":"585.2", "OutcomeMeasurementUpperLimit":"2628.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"356.0", "OutcomeMeasurementLowerLimit":"117.8", "OutcomeMeasurementUpperLimit":"1076.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1300.3", "OutcomeMeasurementLowerLimit":"528.5", "OutcomeMeasurementUpperLimit":"3199.4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"164.0", "OutcomeMeasurementLowerLimit":"52.8", "OutcomeMeasurementUpperLimit":"509.4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"551.7", "OutcomeMeasurementLowerLimit":"231.6", "OutcomeMeasurementUpperLimit":"1313.8" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"13.9", "OutcomeMeasurementLowerLimit":"4.9", "OutcomeMeasurementUpperLimit":"39.2" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"582.3", "OutcomeMeasurementLowerLimit":"275.9", "OutcomeMeasurementUpperLimit":"1229.1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"710.4", "OutcomeMeasurementLowerLimit":"547.5", "OutcomeMeasurementUpperLimit":"921.9" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"29.6", "OutcomeMeasurementLowerLimit":"15.6", "OutcomeMeasurementUpperLimit":"56.1" } ] } } ] } },{ "OutcomeClassTitle":"Day 120, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"156" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2403.7", "OutcomeMeasurementLowerLimit":"1443.5", "OutcomeMeasurementUpperLimit":"4002.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"272.7", "OutcomeMeasurementLowerLimit":"60.9", "OutcomeMeasurementUpperLimit":"1221.6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1754.0", "OutcomeMeasurementLowerLimit":"744.2", "OutcomeMeasurementUpperLimit":"4134.4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"399.9", "OutcomeMeasurementLowerLimit":"109.7", "OutcomeMeasurementUpperLimit":"1457.7" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"983.0", "OutcomeMeasurementLowerLimit":"423.5", "OutcomeMeasurementUpperLimit":"2281.6" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"17.3", "OutcomeMeasurementLowerLimit":"4.6", "OutcomeMeasurementUpperLimit":"65.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"459.7", "OutcomeMeasurementLowerLimit":"232.6", "OutcomeMeasurementUpperLimit":"908.7" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"605.4", "OutcomeMeasurementLowerLimit":"490.6", "OutcomeMeasurementUpperLimit":"747.1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"16.2", "OutcomeMeasurementLowerLimit":"9.5", "OutcomeMeasurementUpperLimit":"27.8" } ] } } ] } },{ "OutcomeClassTitle":"Day 120, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"156" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"650.2", "OutcomeMeasurementLowerLimit":"288.1", "OutcomeMeasurementUpperLimit":"1467.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"287.6", "OutcomeMeasurementLowerLimit":"116.7", "OutcomeMeasurementUpperLimit":"709.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"340.8", "OutcomeMeasurementLowerLimit":"121.3", "OutcomeMeasurementUpperLimit":"957.6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"289.8", "OutcomeMeasurementLowerLimit":"82.7", "OutcomeMeasurementUpperLimit":"1016.1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"377.4", "OutcomeMeasurementLowerLimit":"170.3", "OutcomeMeasurementUpperLimit":"836.6" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"14.4", "OutcomeMeasurementLowerLimit":"5.0", "OutcomeMeasurementUpperLimit":"41.8" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"196.4", "OutcomeMeasurementLowerLimit":"115.2", "OutcomeMeasurementUpperLimit":"334.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"332.3", "OutcomeMeasurementLowerLimit":"263.1", "OutcomeMeasurementUpperLimit":"419.7" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"19.0", "OutcomeMeasurementLowerLimit":"11.3", "OutcomeMeasurementUpperLimit":"32.0" } ] } } ] } },{ "OutcomeClassTitle":"Day 120, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"156" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"193.3", "OutcomeMeasurementLowerLimit":"84.7", "OutcomeMeasurementUpperLimit":"441.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"36.0", "OutcomeMeasurementLowerLimit":"10.5", "OutcomeMeasurementUpperLimit":"123.2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"82.6", "OutcomeMeasurementLowerLimit":"31.8", "OutcomeMeasurementUpperLimit":"214.1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"69.0", "OutcomeMeasurementLowerLimit":"23.5", "OutcomeMeasurementUpperLimit":"202.7" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"64.6", "OutcomeMeasurementLowerLimit":"27.6", "OutcomeMeasurementUpperLimit":"151.1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"13.9", "OutcomeMeasurementLowerLimit":"5.4", "OutcomeMeasurementUpperLimit":"35.3" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"41.3", "OutcomeMeasurementLowerLimit":"24.9", "OutcomeMeasurementUpperLimit":"68.3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"76.5", "OutcomeMeasurementLowerLimit":"60.5", "OutcomeMeasurementUpperLimit":"96.8" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"11.2", "OutcomeMeasurementLowerLimit":"8.0", "OutcomeMeasurementUpperLimit":"15.9" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"831.7", "OutcomeMeasurementLowerLimit":"332.7", "OutcomeMeasurementUpperLimit":"2078.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"320.0", "OutcomeMeasurementLowerLimit":"86.0", "OutcomeMeasurementUpperLimit":"1191.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"954.7", "OutcomeMeasurementLowerLimit":"280.8", "OutcomeMeasurementUpperLimit":"3245.7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"141.6", "OutcomeMeasurementLowerLimit":"38.8", "OutcomeMeasurementUpperLimit":"516.4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"230.5", "OutcomeMeasurementLowerLimit":"107.2", "OutcomeMeasurementUpperLimit":"495.4" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"12.8", "OutcomeMeasurementLowerLimit":"4.7", "OutcomeMeasurementUpperLimit":"34.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"249.2", "OutcomeMeasurementLowerLimit":"113.5", "OutcomeMeasurementUpperLimit":"546.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2521.2", "OutcomeMeasurementLowerLimit":"1444.5", "OutcomeMeasurementUpperLimit":"4400.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"226.3", "OutcomeMeasurementLowerLimit":"48.9", "OutcomeMeasurementUpperLimit":"1046.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1515.6", "OutcomeMeasurementLowerLimit":"593.7", "OutcomeMeasurementUpperLimit":"3869.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"412.3", "OutcomeMeasurementLowerLimit":"104.9", "OutcomeMeasurementUpperLimit":"1620.6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"642.5", "OutcomeMeasurementLowerLimit":"325.9", "OutcomeMeasurementUpperLimit":"1266.8" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"14.4", "OutcomeMeasurementLowerLimit":"4.9", "OutcomeMeasurementUpperLimit":"42.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"399.3", "OutcomeMeasurementLowerLimit":"194.7", "OutcomeMeasurementUpperLimit":"819.1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"422.2", "OutcomeMeasurementLowerLimit":"179.1", "OutcomeMeasurementUpperLimit":"995.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"285.1", "OutcomeMeasurementLowerLimit":"74.7", "OutcomeMeasurementUpperLimit":"1087.6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"321.2", "OutcomeMeasurementLowerLimit":"101.3", "OutcomeMeasurementUpperLimit":"1018.4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"206.1", "OutcomeMeasurementLowerLimit":"65.9", "OutcomeMeasurementUpperLimit":"645.0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"189.1", "OutcomeMeasurementLowerLimit":"84.2", "OutcomeMeasurementUpperLimit":"424.6" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"12.5", "OutcomeMeasurementLowerLimit":"5.5", "OutcomeMeasurementUpperLimit":"28.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"93.6", "OutcomeMeasurementLowerLimit":"41.4", "OutcomeMeasurementUpperLimit":"211.7" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"6.0", "OutcomeMeasurementLowerLimit":"4.0", "OutcomeMeasurementUpperLimit":"9.2" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"146.7", "OutcomeMeasurementLowerLimit":"62.8", "OutcomeMeasurementUpperLimit":"342.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"44.9", "OutcomeMeasurementLowerLimit":"13.0", "OutcomeMeasurementUpperLimit":"155.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"71.5", "OutcomeMeasurementLowerLimit":"27.6", "OutcomeMeasurementUpperLimit":"185.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"51.2", "OutcomeMeasurementLowerLimit":"19.8", "OutcomeMeasurementUpperLimit":"132.4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"47.2", "OutcomeMeasurementLowerLimit":"20.4", "OutcomeMeasurementUpperLimit":"109.3" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"9.2", "OutcomeMeasurementLowerLimit":"4.4", "OutcomeMeasurementUpperLimit":"19.4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"28.3", "OutcomeMeasurementLowerLimit":"14.3", "OutcomeMeasurementUpperLimit":"56.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ 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"OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2410.7", "OutcomeMeasurementLowerLimit":"1120.9", "OutcomeMeasurementUpperLimit":"5185.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"271.8", "OutcomeMeasurementLowerLimit":"60.9", "OutcomeMeasurementUpperLimit":"1212.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"852.2", "OutcomeMeasurementLowerLimit":"369.9", "OutcomeMeasurementUpperLimit":"1963.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"523.6", "OutcomeMeasurementLowerLimit":"113.4", "OutcomeMeasurementUpperLimit":"2416.7" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"329.5", "OutcomeMeasurementLowerLimit":"161.7", "OutcomeMeasurementUpperLimit":"671.1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"17.1", "OutcomeMeasurementLowerLimit":"6.0", "OutcomeMeasurementUpperLimit":"48.7" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"298.8", "OutcomeMeasurementLowerLimit":"141.1", "OutcomeMeasurementUpperLimit":"632.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", 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"OutcomeMeasurementUpperLimit":"574.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"209.5", "OutcomeMeasurementLowerLimit":"55.4", "OutcomeMeasurementUpperLimit":"792.9" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"103.1", "OutcomeMeasurementLowerLimit":"40.0", "OutcomeMeasurementUpperLimit":"265.6" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"11.8", "OutcomeMeasurementLowerLimit":"5.3", "OutcomeMeasurementUpperLimit":"26.0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"89.9", "OutcomeMeasurementLowerLimit":"43.9", "OutcomeMeasurementUpperLimit":"184.1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-4", "OutcomeClassDenomList":{ 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"OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"163.6", "OutcomeMeasurementLowerLimit":"56.2", "OutcomeMeasurementUpperLimit":"476.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"44.9", "OutcomeMeasurementLowerLimit":"13.5", "OutcomeMeasurementUpperLimit":"149.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"73.8", "OutcomeMeasurementLowerLimit":"26.9", "OutcomeMeasurementUpperLimit":"202.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"59.9", "OutcomeMeasurementLowerLimit":"19.4", "OutcomeMeasurementUpperLimit":"184.4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"27.0", "OutcomeMeasurementLowerLimit":"11.9", "OutcomeMeasurementUpperLimit":"61.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"7.5", "OutcomeMeasurementLowerLimit":"4.0", "OutcomeMeasurementUpperLimit":"14.0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"20.0", "OutcomeMeasurementLowerLimit":"10.8", "OutcomeMeasurementUpperLimit":"37.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"924.9", "OutcomeMeasurementLowerLimit":"289.1", "OutcomeMeasurementUpperLimit":"2959.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"691.2", "OutcomeMeasurementLowerLimit":"175.7", "OutcomeMeasurementUpperLimit":"2720.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"452.5", "OutcomeMeasurementLowerLimit":"124.5", "OutcomeMeasurementUpperLimit":"1644.5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"258.5", "OutcomeMeasurementLowerLimit":"67.0", "OutcomeMeasurementUpperLimit":"997.9" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"115.0", "OutcomeMeasurementLowerLimit":"45.4", "OutcomeMeasurementUpperLimit":"291.1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"12.8", "OutcomeMeasurementLowerLimit":"4.8", "OutcomeMeasurementUpperLimit":"34.2" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"248.7", "OutcomeMeasurementLowerLimit":"103.4", "OutcomeMeasurementUpperLimit":"597.9" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.7", "OutcomeMeasurementLowerLimit":"4.2", "OutcomeMeasurementUpperLimit":"7.9" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ 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"OutcomeMeasurementValue":"1399.4", "OutcomeMeasurementLowerLimit":"704.8", "OutcomeMeasurementUpperLimit":"2778.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"244.9", "OutcomeMeasurementLowerLimit":"50.1", "OutcomeMeasurementUpperLimit":"1197.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"714.0", "OutcomeMeasurementLowerLimit":"247.9", "OutcomeMeasurementUpperLimit":"2056.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"396.1", "OutcomeMeasurementLowerLimit":"98.3", "OutcomeMeasurementUpperLimit":"1595.4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"280.4", "OutcomeMeasurementLowerLimit":"135.1", "OutcomeMeasurementUpperLimit":"582.2" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"13.0", "OutcomeMeasurementLowerLimit":"5.0", "OutcomeMeasurementUpperLimit":"33.9" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"219.3", "OutcomeMeasurementLowerLimit":"106.7", "OutcomeMeasurementUpperLimit":"450.7" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.4", "OutcomeMeasurementLowerLimit":"4.6", "OutcomeMeasurementUpperLimit":"6.3" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"515.4", "OutcomeMeasurementLowerLimit":"140.6", "OutcomeMeasurementUpperLimit":"1888.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"403.2", "OutcomeMeasurementLowerLimit":"96.0", "OutcomeMeasurementUpperLimit":"1692.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"154.3", "OutcomeMeasurementLowerLimit":"36.7", "OutcomeMeasurementUpperLimit":"649.1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"303.4", "OutcomeMeasurementLowerLimit":"70.9", "OutcomeMeasurementUpperLimit":"1297.4" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"65.6", "OutcomeMeasurementLowerLimit":"21.2", "OutcomeMeasurementUpperLimit":"203.0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"8.8", "OutcomeMeasurementLowerLimit":"4.5", "OutcomeMeasurementUpperLimit":"17.5" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"104.6", "OutcomeMeasurementLowerLimit":"37.7", "OutcomeMeasurementUpperLimit":"289.8" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"8.1", "OutcomeMeasurementLowerLimit":"2.7", "OutcomeMeasurementUpperLimit":"24.3" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"106.0", "OutcomeMeasurementLowerLimit":"40.5", "OutcomeMeasurementUpperLimit":"277.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"48.5", "OutcomeMeasurementLowerLimit":"13.1", "OutcomeMeasurementUpperLimit":"180.2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"66.7", "OutcomeMeasurementLowerLimit":"22.5", "OutcomeMeasurementUpperLimit":"197.2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"93.9", "OutcomeMeasurementLowerLimit":"29.0", "OutcomeMeasurementUpperLimit":"303.8" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"24.4", "OutcomeMeasurementLowerLimit":"10.8", "OutcomeMeasurementUpperLimit":"55.2" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"8.5", "OutcomeMeasurementLowerLimit":"4.7", "OutcomeMeasurementUpperLimit":"15.2" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"26.6", "OutcomeMeasurementLowerLimit":"12.3", "OutcomeMeasurementUpperLimit":"57.3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.7", "OutcomeMeasurementLowerLimit":"4.2", "OutcomeMeasurementUpperLimit":"7.9" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"718.4", "OutcomeMeasurementLowerLimit":"239.3", "OutcomeMeasurementUpperLimit":"2156.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"905.1", "OutcomeMeasurementLowerLimit":"243.2", "OutcomeMeasurementUpperLimit":"3368.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"508.0", "OutcomeMeasurementLowerLimit":"137.6", "OutcomeMeasurementUpperLimit":"1874.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"219.3", "OutcomeMeasurementLowerLimit":"41.2", "OutcomeMeasurementUpperLimit":"1165.6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"92.8", "OutcomeMeasurementLowerLimit":"36.5", "OutcomeMeasurementUpperLimit":"236.2" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"12.8", "OutcomeMeasurementLowerLimit":"4.8", "OutcomeMeasurementUpperLimit":"34.2" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"149.8", "OutcomeMeasurementLowerLimit":"63.9", "OutcomeMeasurementUpperLimit":"351.1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"6.3", "OutcomeMeasurementLowerLimit":"3.7", "OutcomeMeasurementUpperLimit":"10.7" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"702.0", "OutcomeMeasurementLowerLimit":"403.1", "OutcomeMeasurementUpperLimit":"1222.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"146.7", "OutcomeMeasurementLowerLimit":"27.3", "OutcomeMeasurementUpperLimit":"787.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"615.8", "OutcomeMeasurementLowerLimit":"277.5", "OutcomeMeasurementUpperLimit":"1366.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"256.7", "OutcomeMeasurementLowerLimit":"61.0", "OutcomeMeasurementUpperLimit":"1079.3" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"160.0", "OutcomeMeasurementLowerLimit":"76.5", "OutcomeMeasurementUpperLimit":"334.8" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"12.8", "OutcomeMeasurementLowerLimit":"5.2", "OutcomeMeasurementUpperLimit":"31.7" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"118.9", "OutcomeMeasurementLowerLimit":"57.0", "OutcomeMeasurementUpperLimit":"248.0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.0", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"291.8", "OutcomeMeasurementLowerLimit":"82.5", "OutcomeMeasurementUpperLimit":"1032.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"472.6", "OutcomeMeasurementLowerLimit":"84.6", "OutcomeMeasurementUpperLimit":"2641.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"201.6", "OutcomeMeasurementLowerLimit":"54.6", "OutcomeMeasurementUpperLimit":"744.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"264.9", "OutcomeMeasurementLowerLimit":"53.4", "OutcomeMeasurementUpperLimit":"1313.1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"70.1", "OutcomeMeasurementLowerLimit":"27.6", "OutcomeMeasurementUpperLimit":"178.4" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"9.6", "OutcomeMeasurementLowerLimit":"4.6", "OutcomeMeasurementUpperLimit":"20.1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"80.0", "OutcomeMeasurementLowerLimit":"31.9", "OutcomeMeasurementUpperLimit":"200.7" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"9.3", "OutcomeMeasurementLowerLimit":"2.2", "OutcomeMeasurementUpperLimit":"38.3" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"81.9", "OutcomeMeasurementLowerLimit":"30.9", "OutcomeMeasurementUpperLimit":"216.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"80.0", "OutcomeMeasurementLowerLimit":"17.5", "OutcomeMeasurementUpperLimit":"364.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"61.1", "OutcomeMeasurementLowerLimit":"21.7", "OutcomeMeasurementUpperLimit":"172.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"80.0", "OutcomeMeasurementLowerLimit":"18.9", "OutcomeMeasurementUpperLimit":"338.6" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"17.5", "OutcomeMeasurementLowerLimit":"8.4", "OutcomeMeasurementUpperLimit":"36.6" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"7.2", "OutcomeMeasurementLowerLimit":"4.2", "OutcomeMeasurementUpperLimit":"12.3" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"17.0", "OutcomeMeasurementLowerLimit":"8.6", "OutcomeMeasurementUpperLimit":"33.3" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"5.4", "OutcomeMeasurementLowerLimit":"4.5", "OutcomeMeasurementUpperLimit":"6.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"fold rise", "OutcomeMeasureTimeFrame":"Day 28 and Day 90 (Parts 1 and 2) and Days 120, 180, 360, 720 and 1080 in Part 1", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Day 28, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.41", "OutcomeMeasurementLowerLimit":"1.61", "OutcomeMeasurementUpperLimit":"7.24" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.90", "OutcomeMeasurementLowerLimit":"0.57", "OutcomeMeasurementUpperLimit":"1.41" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8.93", "OutcomeMeasurementLowerLimit":"3.61", "OutcomeMeasurementUpperLimit":"22.09" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.03", "OutcomeMeasurementLowerLimit":"0.67", "OutcomeMeasurementUpperLimit":"1.56" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"29.47", "OutcomeMeasurementLowerLimit":"11.70", "OutcomeMeasurementUpperLimit":"74.22" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"0.88", "OutcomeMeasurementUpperLimit":"1.13" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"27.94", "OutcomeMeasurementLowerLimit":"13.64", "OutcomeMeasurementUpperLimit":"57.23" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.05", "OutcomeMeasurementLowerLimit":"0.94", "OutcomeMeasurementUpperLimit":"1.18" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"27.58", "OutcomeMeasurementLowerLimit":"20.91", "OutcomeMeasurementUpperLimit":"36.38" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0.97", "OutcomeMeasurementLowerLimit":"0.82", "OutcomeMeasurementUpperLimit":"1.16" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.89", "OutcomeMeasurementLowerLimit":"2.01", "OutcomeMeasurementUpperLimit":"31.00" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.71", "OutcomeMeasurementLowerLimit":"0.45", "OutcomeMeasurementUpperLimit":"1.11" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"20.26", "OutcomeMeasurementLowerLimit":"5.34", "OutcomeMeasurementUpperLimit":"76.93" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.05", "OutcomeMeasurementLowerLimit":"0.69", "OutcomeMeasurementUpperLimit":"1.59" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"181.02", "OutcomeMeasurementLowerLimit":"47.86", "OutcomeMeasurementUpperLimit":"684.60" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.39", "OutcomeMeasurementLowerLimit":"0.81", "OutcomeMeasurementUpperLimit":"2.37" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"128.00", "OutcomeMeasurementLowerLimit":"44.62", "OutcomeMeasurementUpperLimit":"367.22" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the lower limit of detection (LLOD)." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"113.02", "OutcomeMeasurementLowerLimit":"0.1", "OutcomeMeasurementUpperLimit":"8192.0" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0.94", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"2.0" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.34", "OutcomeMeasurementLowerLimit":"1.22", "OutcomeMeasurementUpperLimit":"4.52" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.97", "OutcomeMeasurementLowerLimit":"0.74", "OutcomeMeasurementUpperLimit":"1.28" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.40", "OutcomeMeasurementLowerLimit":"1.85", "OutcomeMeasurementUpperLimit":"10.48" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.08", "OutcomeMeasurementLowerLimit":"0.71", "OutcomeMeasurementUpperLimit":"1.63" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"24.17", "OutcomeMeasurementLowerLimit":"10.16", "OutcomeMeasurementUpperLimit":"57.49" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.02", "OutcomeMeasurementLowerLimit":"0.98", "OutcomeMeasurementUpperLimit":"1.07" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"13.76", "OutcomeMeasurementLowerLimit":"6.01", "OutcomeMeasurementUpperLimit":"31.50" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"12.47", "OutcomeMeasurementLowerLimit":"9.18", "OutcomeMeasurementUpperLimit":"16.92" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0.82", "OutcomeMeasurementLowerLimit":"0.71", "OutcomeMeasurementUpperLimit":"0.94" } ] } } ] } },{ "OutcomeClassTitle":"Day 28, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"24" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"158" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.71", "OutcomeMeasurementLowerLimit":"0.88", "OutcomeMeasurementUpperLimit":"3.31" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.11", "OutcomeMeasurementLowerLimit":"0.65", "OutcomeMeasurementUpperLimit":"1.90" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.74", "OutcomeMeasurementLowerLimit":"1.11", "OutcomeMeasurementUpperLimit":"6.80" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.82", "OutcomeMeasurementLowerLimit":"0.53", "OutcomeMeasurementUpperLimit":"1.26" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"7.49", "OutcomeMeasurementLowerLimit":"3.60", "OutcomeMeasurementUpperLimit":"15.58" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.13", "OutcomeMeasurementLowerLimit":"0.94", "OutcomeMeasurementUpperLimit":"1.36" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"4.00", "OutcomeMeasurementLowerLimit":"1.85", "OutcomeMeasurementUpperLimit":"8.66" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.95", "OutcomeMeasurementLowerLimit":"0.84", "OutcomeMeasurementUpperLimit":"1.06" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"74.1", "OutcomeMeasurementLowerLimit":"66.5", "OutcomeMeasurementUpperLimit":"80.7" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"35.8", "OutcomeMeasurementLowerLimit":"23.1", "OutcomeMeasurementUpperLimit":"50.2" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.10", "OutcomeMeasurementLowerLimit":"1.26", "OutcomeMeasurementUpperLimit":"7.59" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.70", "OutcomeMeasurementLowerLimit":"0.75", "OutcomeMeasurementUpperLimit":"3.90" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5.40", "OutcomeMeasurementLowerLimit":"2.50", "OutcomeMeasurementUpperLimit":"11.63" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.08", "OutcomeMeasurementLowerLimit":"0.71", "OutcomeMeasurementUpperLimit":"1.63" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"18.87", "OutcomeMeasurementLowerLimit":"7.61", "OutcomeMeasurementUpperLimit":"46.81" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0.96", "OutcomeMeasurementLowerLimit":"0.88", "OutcomeMeasurementUpperLimit":"1.05" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"11.14", "OutcomeMeasurementLowerLimit":"5.37", "OutcomeMeasurementUpperLimit":"23.09" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.000", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"324.2", "OutcomeMeasurementLowerLimit":"239.1", "OutcomeMeasurementUpperLimit":"439.6" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"27.9", "OutcomeMeasurementLowerLimit":"14.6", "OutcomeMeasurementUpperLimit":"53.4" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.09", "OutcomeMeasurementLowerLimit":"2.20", "OutcomeMeasurementUpperLimit":"22.83" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.27", "OutcomeMeasurementLowerLimit":"0.78", "OutcomeMeasurementUpperLimit":"2.08" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"13.45", "OutcomeMeasurementLowerLimit":"4.52", "OutcomeMeasurementUpperLimit":"40.08" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.16", "OutcomeMeasurementLowerLimit":"0.74", "OutcomeMeasurementUpperLimit":"1.83" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"74.25", "OutcomeMeasurementLowerLimit":"30.35", "OutcomeMeasurementUpperLimit":"181.64" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"0.88", "OutcomeMeasurementUpperLimit":"1.13" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"51.33", "OutcomeMeasurementLowerLimit":"20.33", "OutcomeMeasurementUpperLimit":"129.62" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"463.5", "OutcomeMeasurementLowerLimit":"364.0", "OutcomeMeasurementUpperLimit":"590.2" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"15.2", "OutcomeMeasurementLowerLimit":"8.9", "OutcomeMeasurementUpperLimit":"25.9" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.29", "OutcomeMeasurementLowerLimit":"1.29", "OutcomeMeasurementUpperLimit":"4.05" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.17", "OutcomeMeasurementLowerLimit":"0.74", "OutcomeMeasurementUpperLimit":"1.85" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.57", "OutcomeMeasurementLowerLimit":"1.14", "OutcomeMeasurementUpperLimit":"5.80" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.19", "OutcomeMeasurementLowerLimit":"0.67", "OutcomeMeasurementUpperLimit":"2.13" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"14.98", "OutcomeMeasurementLowerLimit":"6.11", "OutcomeMeasurementUpperLimit":"36.75" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.02", "OutcomeMeasurementLowerLimit":"0.92", "OutcomeMeasurementUpperLimit":"1.13" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"6.83", "OutcomeMeasurementLowerLimit":"3.13", "OutcomeMeasurementUpperLimit":"14.93" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.07", "OutcomeMeasurementLowerLimit":"0.93", "OutcomeMeasurementUpperLimit":"1.23" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"139.5", "OutcomeMeasurementLowerLimit":"99.7", "OutcomeMeasurementUpperLimit":"195.1" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"17.1", "OutcomeMeasurementLowerLimit":"10.2", "OutcomeMeasurementUpperLimit":"28.5" } ] } } ] } },{ "OutcomeClassTitle":"Day 90, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"23" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"159" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.64", "OutcomeMeasurementLowerLimit":"1.02", "OutcomeMeasurementUpperLimit":"2.66" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.73", "OutcomeMeasurementLowerLimit":"0.52", "OutcomeMeasurementUpperLimit":"1.01" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.70", "OutcomeMeasurementLowerLimit":"1.78", "OutcomeMeasurementUpperLimit":"7.66" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.22", "OutcomeMeasurementLowerLimit":"0.72", "OutcomeMeasurementUpperLimit":"2.07" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"3.81", "OutcomeMeasurementLowerLimit":"1.73", "OutcomeMeasurementUpperLimit":"8.36" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.18", "OutcomeMeasurementLowerLimit":"0.90", "OutcomeMeasurementUpperLimit":"1.54" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2.45", "OutcomeMeasurementLowerLimit":"1.39", "OutcomeMeasurementUpperLimit":"4.32" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"0.81", "OutcomeMeasurementUpperLimit":"1.23" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"33.7", "OutcomeMeasurementLowerLimit":"25.4", "OutcomeMeasurementUpperLimit":"44.7" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"11.8", "OutcomeMeasurementLowerLimit":"8.2", "OutcomeMeasurementUpperLimit":"16.9" } ] } } ] } },{ "OutcomeClassTitle":"Day 120, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"156" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.64", "OutcomeMeasurementLowerLimit":"1.09", "OutcomeMeasurementUpperLimit":"12.10" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.81", "OutcomeMeasurementLowerLimit":"0.56", "OutcomeMeasurementUpperLimit":"1.16" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"12.63", "OutcomeMeasurementLowerLimit":"5.56", "OutcomeMeasurementUpperLimit":"28.70" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.82", "OutcomeMeasurementLowerLimit":"0.34", "OutcomeMeasurementUpperLimit":"2.01" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"42.36", "OutcomeMeasurementLowerLimit":"19.57", "OutcomeMeasurementUpperLimit":"91.70" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.23", "OutcomeMeasurementLowerLimit":"0.72", "OutcomeMeasurementUpperLimit":"2.09" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"39.27", "OutcomeMeasurementLowerLimit":"24.12", "OutcomeMeasurementUpperLimit":"63.94" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"35.44", "OutcomeMeasurementLowerLimit":"26.46", "OutcomeMeasurementUpperLimit":"47.48" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1.01", "OutcomeMeasurementLowerLimit":"0.79", "OutcomeMeasurementUpperLimit":"1.28" } ] } } ] } },{ "OutcomeClassTitle":"Day 120, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"156" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.79", "OutcomeMeasurementLowerLimit":"2.81", "OutcomeMeasurementUpperLimit":"27.47" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.08", "OutcomeMeasurementLowerLimit":"0.79", "OutcomeMeasurementUpperLimit":"1.49" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"20.59", "OutcomeMeasurementLowerLimit":"6.45", "OutcomeMeasurementUpperLimit":"65.66" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"0.67", "OutcomeMeasurementUpperLimit":"1.50" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"75.48", "OutcomeMeasurementLowerLimit":"29.82", "OutcomeMeasurementUpperLimit":"191.08" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.73", "OutcomeMeasurementLowerLimit":"0.56", "OutcomeMeasurementUpperLimit":"5.38" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"50.53", "OutcomeMeasurementLowerLimit":"24.11", "OutcomeMeasurementUpperLimit":"105.89" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"44.16", "OutcomeMeasurementLowerLimit":"33.51", "OutcomeMeasurementUpperLimit":"58.20" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0.92", "OutcomeMeasurementLowerLimit":"0.67", "OutcomeMeasurementUpperLimit":"1.28" } ] } } ] } },{ "OutcomeClassTitle":"Day 120, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"156" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.78", "OutcomeMeasurementLowerLimit":"1.44", "OutcomeMeasurementUpperLimit":"5.37" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.24", "OutcomeMeasurementLowerLimit":"0.70", "OutcomeMeasurementUpperLimit":"2.20" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.54", "OutcomeMeasurementLowerLimit":"2.02", "OutcomeMeasurementUpperLimit":"10.17" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.03", "OutcomeMeasurementLowerLimit":"0.60", "OutcomeMeasurementUpperLimit":"1.75" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"28.98", "OutcomeMeasurementLowerLimit":"14.52", "OutcomeMeasurementUpperLimit":"57.87" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.73", "OutcomeMeasurementLowerLimit":"0.73", "OutcomeMeasurementUpperLimit":"4.14" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"20.26", "OutcomeMeasurementLowerLimit":"12.02", "OutcomeMeasurementUpperLimit":"34.17" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"19.20", "OutcomeMeasurementLowerLimit":"14.75", "OutcomeMeasurementUpperLimit":"24.98" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"0.80", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"1.01" } ] } } ] } },{ "OutcomeClassTitle":"Day 120, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"156" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"53" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.45", "OutcomeMeasurementLowerLimit":"1.44", "OutcomeMeasurementUpperLimit":"4.19" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.73", "OutcomeMeasurementLowerLimit":"0.43", "OutcomeMeasurementUpperLimit":"1.23" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.00", "OutcomeMeasurementLowerLimit":"2.00", "OutcomeMeasurementUpperLimit":"8.00" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.22", "OutcomeMeasurementLowerLimit":"0.72", "OutcomeMeasurementUpperLimit":"2.07" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"7.87", "OutcomeMeasurementLowerLimit":"4.25", "OutcomeMeasurementUpperLimit":"14.57" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"2.17", "OutcomeMeasurementLowerLimit":"0.99", "OutcomeMeasurementUpperLimit":"4.76" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"6.02", "OutcomeMeasurementLowerLimit":"3.81", "OutcomeMeasurementUpperLimit":"9.53" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.94", "OutcomeMeasurementLowerLimit":"0.82", "OutcomeMeasurementUpperLimit":"1.08" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"7.43", "OutcomeMeasurementLowerLimit":"5.96", "OutcomeMeasurementUpperLimit":"9.27" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1.03", "OutcomeMeasurementLowerLimit":"0.91", "OutcomeMeasurementUpperLimit":"1.16" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.94", "OutcomeMeasurementLowerLimit":"1.35", "OutcomeMeasurementUpperLimit":"11.54" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.89", "OutcomeMeasurementLowerLimit":"0.59", "OutcomeMeasurementUpperLimit":"1.35" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9.16", "OutcomeMeasurementLowerLimit":"2.89", "OutcomeMeasurementUpperLimit":"29.05" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.71", "OutcomeMeasurementLowerLimit":"0.45", "OutcomeMeasurementUpperLimit":"1.10" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"17.70", "OutcomeMeasurementLowerLimit":"10.04", "OutcomeMeasurementUpperLimit":"31.22" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.13", "OutcomeMeasurementLowerLimit":"0.77", "OutcomeMeasurementUpperLimit":"1.66" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"16.81", "OutcomeMeasurementLowerLimit":"9.56", "OutcomeMeasurementUpperLimit":"29.53" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11.53", "OutcomeMeasurementLowerLimit":"3.61", "OutcomeMeasurementUpperLimit":"36.83" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.94", "OutcomeMeasurementLowerLimit":"0.55", "OutcomeMeasurementUpperLimit":"1.63" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"17.16", "OutcomeMeasurementLowerLimit":"5.15", "OutcomeMeasurementUpperLimit":"57.17" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.03", "OutcomeMeasurementLowerLimit":"0.58", "OutcomeMeasurementUpperLimit":"1.84" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"49.34", "OutcomeMeasurementLowerLimit":"22.02", "OutcomeMeasurementUpperLimit":"110.57" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.44", "OutcomeMeasurementLowerLimit":"0.66", "OutcomeMeasurementUpperLimit":"3.17" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"43.89", "OutcomeMeasurementLowerLimit":"21.22", "OutcomeMeasurementUpperLimit":"90.80" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.42", "OutcomeMeasurementLowerLimit":"1.23", "OutcomeMeasurementUpperLimit":"4.76" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.26", "OutcomeMeasurementLowerLimit":"0.95", "OutcomeMeasurementUpperLimit":"1.68" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.58", "OutcomeMeasurementLowerLimit":"1.72", "OutcomeMeasurementUpperLimit":"12.21" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.73", "OutcomeMeasurementLowerLimit":"0.44", "OutcomeMeasurementUpperLimit":"1.20" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"14.52", "OutcomeMeasurementLowerLimit":"7.70", "OutcomeMeasurementUpperLimit":"27.38" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.50", "OutcomeMeasurementLowerLimit":"0.86", "OutcomeMeasurementUpperLimit":"2.64" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"9.66", "OutcomeMeasurementLowerLimit":"4.84", "OutcomeMeasurementUpperLimit":"19.30" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.21", "OutcomeMeasurementLowerLimit":"0.79", "OutcomeMeasurementUpperLimit":"1.84" } ] } } ] } },{ "OutcomeClassTitle":"Day 180, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"20" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"14" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.38", "OutcomeMeasurementLowerLimit":"1.43", "OutcomeMeasurementUpperLimit":"3.95" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"0.63", "OutcomeMeasurementUpperLimit":"1.58" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.35", "OutcomeMeasurementLowerLimit":"1.60", "OutcomeMeasurementUpperLimit":"7.01" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.91", "OutcomeMeasurementLowerLimit":"0.60", "OutcomeMeasurementUpperLimit":"1.37" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"5.76", "OutcomeMeasurementLowerLimit":"3.14", "OutcomeMeasurementUpperLimit":"10.55" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.44", "OutcomeMeasurementLowerLimit":"0.88", "OutcomeMeasurementUpperLimit":"2.36" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"4.13", "OutcomeMeasurementLowerLimit":"2.29", "OutcomeMeasurementUpperLimit":"7.43" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.94", "OutcomeMeasurementLowerLimit":"0.82", "OutcomeMeasurementUpperLimit":"1.08" } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-1", "OutcomeClassDenomList":{ 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"OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.51", "OutcomeMeasurementLowerLimit":"2.13", "OutcomeMeasurementUpperLimit":"14.26" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.67", "OutcomeMeasurementLowerLimit":"0.47", "OutcomeMeasurementUpperLimit":"0.95" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6.17", "OutcomeMeasurementLowerLimit":"2.36", "OutcomeMeasurementUpperLimit":"16.14" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.09", "OutcomeMeasurementLowerLimit":"0.50", "OutcomeMeasurementUpperLimit":"2.37" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"10.14", "OutcomeMeasurementLowerLimit":"4.81", "OutcomeMeasurementUpperLimit":"21.39" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.39", "OutcomeMeasurementLowerLimit":"0.91", "OutcomeMeasurementUpperLimit":"2.12" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"14.90", "OutcomeMeasurementLowerLimit":"7.48", "OutcomeMeasurementUpperLimit":"29.66" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.07", "OutcomeMeasurementLowerLimit":"0.93", "OutcomeMeasurementUpperLimit":"1.23" } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.04", "OutcomeMeasurementLowerLimit":"2.76", "OutcomeMeasurementUpperLimit":"29.60" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.93", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"1.34" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9.65", "OutcomeMeasurementLowerLimit":"3.34", "OutcomeMeasurementUpperLimit":"27.83" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.16", "OutcomeMeasurementLowerLimit":"0.54", "OutcomeMeasurementUpperLimit":"2.46" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"25.30", "OutcomeMeasurementLowerLimit":"10.10", "OutcomeMeasurementUpperLimit":"63.38" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.71", "OutcomeMeasurementLowerLimit":"0.81", "OutcomeMeasurementUpperLimit":"3.59" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"32.84", "OutcomeMeasurementLowerLimit":"15.76", "OutcomeMeasurementUpperLimit":"68.42" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { 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"OutcomeMeasurementLowerLimit":"1.21", "OutcomeMeasurementUpperLimit":"5.39" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.95", "OutcomeMeasurementLowerLimit":"0.71", "OutcomeMeasurementUpperLimit":"1.27" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.44", "OutcomeMeasurementLowerLimit":"1.00", "OutcomeMeasurementUpperLimit":"5.96" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.83", "OutcomeMeasurementLowerLimit":"0.44", "OutcomeMeasurementUpperLimit":"1.57" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"7.92", "OutcomeMeasurementLowerLimit":"3.28", "OutcomeMeasurementUpperLimit":"19.10" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.41", "OutcomeMeasurementLowerLimit":"0.88", "OutcomeMeasurementUpperLimit":"2.29" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"9.28", "OutcomeMeasurementLowerLimit":"4.55", "OutcomeMeasurementUpperLimit":"18.92" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 360, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"12" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.32", "OutcomeMeasurementLowerLimit":"1.15", "OutcomeMeasurementUpperLimit":"4.70" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.75", "OutcomeMeasurementLowerLimit":"0.53", "OutcomeMeasurementUpperLimit":"1.06" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.45", "OutcomeMeasurementLowerLimit":"1.66", "OutcomeMeasurementUpperLimit":"7.17" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.03", "OutcomeMeasurementLowerLimit":"0.45", "OutcomeMeasurementUpperLimit":"2.38" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"3.29", "OutcomeMeasurementLowerLimit":"1.83", "OutcomeMeasurementUpperLimit":"5.89" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.18", "OutcomeMeasurementLowerLimit":"0.96", "OutcomeMeasurementUpperLimit":"1.44" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2.92", "OutcomeMeasurementLowerLimit":"1.71", "OutcomeMeasurementUpperLimit":"4.98" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.94", "OutcomeMeasurementLowerLimit":"0.82", "OutcomeMeasurementUpperLimit":"1.08" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.65", "OutcomeMeasurementLowerLimit":"1.45", "OutcomeMeasurementUpperLimit":"14.97" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.63", "OutcomeMeasurementLowerLimit":"0.43", "OutcomeMeasurementUpperLimit":"0.92" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.65", "OutcomeMeasurementLowerLimit":"1.68", "OutcomeMeasurementUpperLimit":"7.96" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.27", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"2.54" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"8.83", "OutcomeMeasurementLowerLimit":"4.69", "OutcomeMeasurementUpperLimit":"16.64" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.13", "OutcomeMeasurementLowerLimit":"0.87", "OutcomeMeasurementUpperLimit":"1.46" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"16.77", "OutcomeMeasurementLowerLimit":"7.12", "OutcomeMeasurementUpperLimit":"39.51" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.15", "OutcomeMeasurementLowerLimit":"0.84", "OutcomeMeasurementUpperLimit":"1.57" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.13", "OutcomeMeasurementLowerLimit":"2.52", "OutcomeMeasurementUpperLimit":"33.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.80", "OutcomeMeasurementLowerLimit":"0.51", "OutcomeMeasurementUpperLimit":"1.24" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8.61", "OutcomeMeasurementLowerLimit":"3.28", "OutcomeMeasurementUpperLimit":"22.56" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.88", "OutcomeMeasurementLowerLimit":"0.52", "OutcomeMeasurementUpperLimit":"1.48" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"21.53", "OutcomeMeasurementLowerLimit":"9.91", "OutcomeMeasurementUpperLimit":"46.81" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.30", "OutcomeMeasurementLowerLimit":"0.73", "OutcomeMeasurementUpperLimit":"2.32" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"24.10", "OutcomeMeasurementLowerLimit":"11.73", "OutcomeMeasurementUpperLimit":"49.52" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.07", "OutcomeMeasurementLowerLimit":"0.92", "OutcomeMeasurementUpperLimit":"1.25" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.15", "OutcomeMeasurementLowerLimit":"1.38", "OutcomeMeasurementUpperLimit":"7.21" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.93", "OutcomeMeasurementLowerLimit":"0.67", "OutcomeMeasurementUpperLimit":"1.28" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.00", "OutcomeMeasurementLowerLimit":"0.76", "OutcomeMeasurementUpperLimit":"5.28" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.21", "OutcomeMeasurementLowerLimit":"0.72", "OutcomeMeasurementUpperLimit":"2.02" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"5.04", "OutcomeMeasurementLowerLimit":"2.21", "OutcomeMeasurementUpperLimit":"11.50" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.06", "OutcomeMeasurementLowerLimit":"0.80", "OutcomeMeasurementUpperLimit":"1.41" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"10.79", "OutcomeMeasurementLowerLimit":"4.16", "OutcomeMeasurementUpperLimit":"28.00" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.62", "OutcomeMeasurementLowerLimit":"0.54", "OutcomeMeasurementUpperLimit":"4.87" } ] } } ] } },{ "OutcomeClassTitle":"Day 720, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"16" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"19" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"13" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"22" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"10" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.54", "OutcomeMeasurementLowerLimit":"0.77", "OutcomeMeasurementUpperLimit":"3.10" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.56", "OutcomeMeasurementLowerLimit":"0.39", "OutcomeMeasurementUpperLimit":"0.82" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.88", "OutcomeMeasurementLowerLimit":"1.41", "OutcomeMeasurementUpperLimit":"5.90" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.62", "OutcomeMeasurementLowerLimit":"0.76", "OutcomeMeasurementUpperLimit":"3.43" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2.97", "OutcomeMeasurementLowerLimit":"1.56", "OutcomeMeasurementUpperLimit":"5.66" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.33", "OutcomeMeasurementLowerLimit":"0.95", "OutcomeMeasurementUpperLimit":"1.86" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"3.88", "OutcomeMeasurementLowerLimit":"1.89", "OutcomeMeasurementUpperLimit":"7.96" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.07", "OutcomeMeasurementLowerLimit":"0.74", "OutcomeMeasurementUpperLimit":"1.55" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-1", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.91", "OutcomeMeasurementLowerLimit":"1.40", "OutcomeMeasurementUpperLimit":"10.94" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.77", "OutcomeMeasurementLowerLimit":"0.45", "OutcomeMeasurementUpperLimit":"1.31" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.43", "OutcomeMeasurementLowerLimit":"1.66", "OutcomeMeasurementUpperLimit":"7.08" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.33", "OutcomeMeasurementLowerLimit":"0.73", "OutcomeMeasurementUpperLimit":"2.41" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"7.13", "OutcomeMeasurementLowerLimit":"3.86", "OutcomeMeasurementUpperLimit":"13.17" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.13", "OutcomeMeasurementLowerLimit":"0.79", "OutcomeMeasurementUpperLimit":"1.62" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"9.59", "OutcomeMeasurementLowerLimit":"4.72", "OutcomeMeasurementUpperLimit":"19.48" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.26", "OutcomeMeasurementLowerLimit":"0.74", "OutcomeMeasurementUpperLimit":"2.15" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-2", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.59", "OutcomeMeasurementLowerLimit":"1.45", "OutcomeMeasurementUpperLimit":"14.59" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.68", "OutcomeMeasurementLowerLimit":"0.51", "OutcomeMeasurementUpperLimit":"0.90" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6.35", "OutcomeMeasurementLowerLimit":"2.54", "OutcomeMeasurementUpperLimit":"15.87" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.83", "OutcomeMeasurementLowerLimit":"0.51", "OutcomeMeasurementUpperLimit":"1.34" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"12.29", "OutcomeMeasurementLowerLimit":"5.76", "OutcomeMeasurementUpperLimit":"26.22" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.28", "OutcomeMeasurementLowerLimit":"0.73", "OutcomeMeasurementUpperLimit":"2.24" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"12.70", "OutcomeMeasurementLowerLimit":"5.92", "OutcomeMeasurementUpperLimit":"27.25" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Lower and upper limits of CI could not be evaluated as titers were below the LLOD." } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-3", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.87", "OutcomeMeasurementLowerLimit":"0.98", "OutcomeMeasurementUpperLimit":"3.54" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.04", "OutcomeMeasurementLowerLimit":"0.75", "OutcomeMeasurementUpperLimit":"1.45" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.33", "OutcomeMeasurementLowerLimit":"0.97", "OutcomeMeasurementUpperLimit":"5.59" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.17", "OutcomeMeasurementLowerLimit":"0.65", "OutcomeMeasurementUpperLimit":"2.10" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"5.38", "OutcomeMeasurementLowerLimit":"2.71", "OutcomeMeasurementUpperLimit":"10.71" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.15", "OutcomeMeasurementLowerLimit":"0.89", "OutcomeMeasurementUpperLimit":"1.50" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"8.55", "OutcomeMeasurementLowerLimit":"3.97", "OutcomeMeasurementUpperLimit":"18.38" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.85", "OutcomeMeasurementLowerLimit":"0.45", "OutcomeMeasurementUpperLimit":"7.67" } ] } } ] } },{ "OutcomeClassTitle":"Day 1080, TDV-4", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"15" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"8" },{ "OutcomeClassDenomCountGroupId":"OG002", "OutcomeClassDenomCountValue":"18" },{ "OutcomeClassDenomCountGroupId":"OG003", "OutcomeClassDenomCountValue":"11" },{ "OutcomeClassDenomCountGroupId":"OG004", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG005", "OutcomeClassDenomCountValue":"17" },{ "OutcomeClassDenomCountGroupId":"OG006", "OutcomeClassDenomCountValue":"21" },{ "OutcomeClassDenomCountGroupId":"OG007", "OutcomeClassDenomCountValue":"9" },{ "OutcomeClassDenomCountGroupId":"OG008", "OutcomeClassDenomCountValue":"0" },{ "OutcomeClassDenomCountGroupId":"OG009", "OutcomeClassDenomCountValue":"0" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.15", "OutcomeMeasurementLowerLimit":"0.71", "OutcomeMeasurementUpperLimit":"1.87" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"0.58", "OutcomeMeasurementUpperLimit":"1.71" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.42", "OutcomeMeasurementLowerLimit":"1.18", "OutcomeMeasurementUpperLimit":"4.98" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.46", "OutcomeMeasurementLowerLimit":"0.66", "OutcomeMeasurementUpperLimit":"3.21" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2.14", "OutcomeMeasurementLowerLimit":"1.23", "OutcomeMeasurementUpperLimit":"3.72" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1.13", "OutcomeMeasurementLowerLimit":"0.94", "OutcomeMeasurementUpperLimit":"1.36" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"2.44", "OutcomeMeasurementLowerLimit":"1.40", "OutcomeMeasurementUpperLimit":"4.25" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"0.77", "OutcomeMeasurementUpperLimit":"1.31" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Confirmed Dengue Fever", "OutcomeMeasureDescription":"Dengue fever was assessed in participants who had 3 consecutive days of fever >38°C and tested positive for dengue virus by polymerase chain reaction (PCR) analysis.", "OutcomeMeasurePopulationDescription":"The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Day 1 to Day 1080", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part I: TDV 21 to 45 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part I: Placebo 21 to 45 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part I: TDV 12 to 20 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part I: Placebo 12 to 20 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years." },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part I: TDV 6 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part I: Placebo 6 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years." },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part I: TDV 1.5 to 5 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part I: Placebo 1.5 to 5 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Part II: TDV 1.5 to 11 Years", "OutcomeGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU." },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Part II: Placebo 1.5 to 11 Years", "OutcomeGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"21" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"17" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"159" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Serious AEs were collected throughout the study Day 0 up to Day 1080. Other (non-serious) AEs were collected within 28 days of all vaccinations (up to Day 28 and Day 118).", "EventsDescription":"At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Part I: TDV 21 to 45 Years", "EventGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 plaque forming units (PFU), 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "EventGroupSeriousNumAffected":"4", "EventGroupSeriousNumAtRisk":"24", "EventGroupOtherNumAffected":"11", "EventGroupOtherNumAtRisk":"24" },{ "EventGroupId":"EG001", "EventGroupTitle":"Part I: Placebo 21 to 45 Years", "EventGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 21 to 45 years.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"14", "EventGroupOtherNumAffected":"7", "EventGroupOtherNumAtRisk":"14" },{ "EventGroupId":"EG002", "EventGroupTitle":"Part I: TDV 12 to 20 Years", "EventGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"22", "EventGroupOtherNumAffected":"13", "EventGroupOtherNumAtRisk":"22" },{ "EventGroupId":"EG003", "EventGroupTitle":"Part I: Placebo 12 to 20 Years", "EventGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 12 to 20 years.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"14", "EventGroupOtherNumAffected":"8", "EventGroupOtherNumAtRisk":"14" },{ "EventGroupId":"EG004", "EventGroupTitle":"Part I: TDV 6 to 11 Years", "EventGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "EventGroupSeriousNumAffected":"4", "EventGroupSeriousNumAtRisk":"21", "EventGroupOtherNumAffected":"9", "EventGroupOtherNumAtRisk":"21" },{ "EventGroupId":"EG005", "EventGroupTitle":"Part I: Placebo 6 to 11 Years", "EventGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 6 to 11 years.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"17", "EventGroupOtherNumAffected":"11", "EventGroupOtherNumAtRisk":"17" },{ "EventGroupId":"EG006", "EventGroupTitle":"Part I: TDV 1.5 to 5 Years", "EventGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"23", "EventGroupOtherNumAffected":"14", "EventGroupOtherNumAtRisk":"23" },{ "EventGroupId":"EG007", "EventGroupTitle":"Part I: Placebo 1.5 to 5 Years", "EventGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"13", "EventGroupOtherNumAffected":"12", "EventGroupOtherNumAtRisk":"13" },{ "EventGroupId":"EG008", "EventGroupTitle":"Part II: TDV 1.5 to 11 Years", "EventGroupDescription":"TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 11 years. TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.", "EventGroupSeriousNumAffected":"14", "EventGroupSeriousNumAtRisk":"159", "EventGroupOtherNumAffected":"87", "EventGroupOtherNumAtRisk":"159" },{ "EventGroupId":"EG009", "EventGroupTitle":"Part II: Placebo 1.5 to 11 Years", "EventGroupDescription":"TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose) in participants aged 1.5 to 5 years.", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"53", "EventGroupOtherNumAffected":"30", "EventGroupOtherNumAtRisk":"53" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Cholecystitis", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG008", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG009", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Cholecystitis acute", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG008", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG009", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Incision site haematoma", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG008", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG009", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Incision site haemorrhage", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG008", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG009", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Brain contusion", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG008", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG009", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Child maltreatment syndrome", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG008", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG009", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Forearm fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG008", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG009", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Skull fractured base", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG008", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG009", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Abortion spontaneous", "SeriousEventOrganSystem":"Pregnancy, puerperium and perinatal conditions", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG008", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG009", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Abscess limb", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ 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"SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG008", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"159" },{ "SeriousEventStatsGroupId":"EG009", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"53" } ] } },{ "SeriousEventTerm":"Bronchitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", 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"SeriousEventSourceVocabulary":"MedDRA (14.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"22" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"17" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"23" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumAffected":"1", 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