{ "FullStudy":{ "Rank":217851, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516008", "OrgStudyIdInfo":{ "OrgStudyId":"CR100459" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"R331333PAI3030", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Janssen Research & Development, LLC" } ] }, "Organization":{ "OrgFullName":"Janssen Research & Development, LLC", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy", "OfficialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy; Bridging Study for Korea" }, "StatusModule":{ "StatusVerifiedDate":"March 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 24, 2014", "ResultsFirstSubmitQCDate":"March 28, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"April 28, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 28, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 28, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Janssen Research & Development, LLC", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR 50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours (SPID48) to measure analgesic effect in Korean patients with acute pain following bunionectomy.", "DetailedDescription":"This is a randomized (study drug assigned by chance like flipping a coin), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of tapentadol immediate-release (IR) 50 mg and 75 mg in patients who are undergoing bunionectomy (a surgical procedure to remove a bunion). This study was designed to be a similar study to the pivotal global study of PAI-3003/KF32 in order to bridge the results from the global studies and to show similarity in effect of tapentadol between Korean and Caucasian population which will allow extrapolation of the foreign clinical data of tapentadol into Korea. The study will be divided into screening period, surgical period, qualification period, and a double-blind treatment period. The study length, including the screening period, will be up to a maximum duration of 32 days. Eligible patients will be randomly assigned to 1 of 3 treatment groups (tapentadol IR 50 mg, tapentadol IR 75 mg or placebo) in a 1:1:1 ratio. Efficacy and safety assessments will be performed during the study." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hallux Valgus" ] }, "KeywordList":{ "Keyword":[ "Hallux Valgus", "Bunionectomy", "Bunion", "Acute pain", "Tapentadol", "Tapentadol IR" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"353", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Tapentadol IR 50 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Tapentadol IR 50 mg" ] } },{ "ArmGroupLabel":"Tapentadol IR 75 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Tapentadol IR 75 mg" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Tapentadol IR 50 mg", "InterventionDescription":"Type= exact number, unit= mg, number= 50, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Tapentadol IR 50 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"Tapentadol IR 75 mg", "InterventionDescription":"Type= exact number, unit= mg, number= 75, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Tapentadol IR 75 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Form= tablet, route= oral use. Placebo tablets will be administered as a single oral dose every 4 to 6 hours, for a period of 72 hours.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Sum of Pain Intensity Differences (SPID) Over 48 Hours", "PrimaryOutcomeDescription":"Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.", "PrimaryOutcomeTimeFrame":"48 hours" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Time to First Rescue Medication Use", "SecondaryOutcomeDescription":"Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.", "SecondaryOutcomeTimeFrame":"Up to 48 hours" },{ "SecondaryOutcomeMeasure":"Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours", "SecondaryOutcomeDescription":"Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.", "SecondaryOutcomeTimeFrame":"Baseline (Day 1) and 12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours", "SecondaryOutcomeDescription":"Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.", "SecondaryOutcomeTimeFrame":"12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours", "SecondaryOutcomeDescription":"Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.", "SecondaryOutcomeTimeFrame":"12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours", "SecondaryOutcomeDescription":"Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.", "SecondaryOutcomeTimeFrame":"12, 24, and 72 hours" },{ "SecondaryOutcomeMeasure":"Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours", "SecondaryOutcomeDescription":"Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72 hours. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.", "SecondaryOutcomeTimeFrame":"12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours", "SecondaryOutcomeDescription":"Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.", "SecondaryOutcomeTimeFrame":"12, 24, 48, and 72 hours" },{ "SecondaryOutcomeMeasure":"Patient Global Impression of Change (PGI-C) Score at 72 Hours", "SecondaryOutcomeDescription":"The PGI-C is a 7-point scale that requires the patients to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.", "SecondaryOutcomeTimeFrame":"Baseline (Day 1) and 72 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients who are undergoing primary unilateral first metatarsal bunionectomy that includes a distal Chevron osteotomy only with or without the Akin procedure\nHealthy or medically stable on the basis of clinical laboratory tests performed at screening. If results are outside the normal reference ranges, the patient may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study\nWomen must be postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study. Women of childbearing potential must have a negative serum β human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test before surgery\nIf a male and sexually active, agrees to use an approved method of birth control to prevent pregnancy in his female partner and not to donate sperm from the day of first study drug intake until 3 months after the day of last study drug intake. To qualify for entry into the double-blind treatment period, the following criteria must be met:\nQualifying baseline pain intensity (PI) must be rated as greater than or equal to 4 on an 11-point (0 to10) PI numerical rating scale (NRS), recorded within 30 minutes before randomization\nQualifying PI must occur no earlier than 10 hours after the first surgical incision\nQualifying baseline PI must occur within 9 hours after termination of the systemic analgesia during the postoperative surgical period\n\nExclusion Criteria:\n\nHistory of seizure disorder or epilepsy suggested by the presence of mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, and/or severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, or posttraumatic amnesia of more than 24 hours duration within 15 years of screening\nHistory of malignancy within the past 2 years before the start of the study\nEvidence of active infections that may spread to other areas of the body or a history of human immunodeficiency virus 1 or 2\nClinical laboratory values reflecting severe renal insufficiency\nModerately or severely impaired hepatic function, or patients with abnormal alanine aminotransaminase or aspartate aminotransferase\nClinical laboratory values outside acceptable limits for surgery in the opinion of the investigator\nA clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments\nTreated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or serotonin norepinephrine reuptake inhibitor within 2 weeks before randomization\nSystemic steroid therapy, excluding inhalers or topical steroids, within the 4 weeks before screening\nWomen who plan to become pregnant during the study, or who are breast feeding", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "MaximumAge":"80 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Janssen Research & Development, LLC Clinical Trial", "OverallOfficialAffiliation":"Janssen Research & Development, LLC", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Busan", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Chungcheongbuk-Do", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Gwangju", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Gyeonggi-Do", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Pusan", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Seoul", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Ulsan", "LocationCountry":"Korea, Republic of" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25133962", "ReferenceType":"derived", "ReferenceCitation":"Lee YK, Ko JS, Rhim HY, Lee EJ, Karcher K, Li H, Shapiro D, Lee HS. Acute postoperative pain relief with immediate-release tapentadol: randomized, double-blind, placebo-controlled study conducted in South Korea. Curr Med Res Opin. 2014 Dec;30(12):2561-70. doi: 10.1185/03007995.2014.954665. Epub 2014 Aug 27." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"353 participants were randomly allocated to the 3 treatment arms. 352 participants received at least 1 dose of the study drug and were included in the intent-to-treat (ITT) analysis set.", "FlowRecruitmentDetails":"The study was conducted from 11 January 2012 to 2 February 2013. Participants were recruited at 17 study centers in Korea.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"Each participant received matching placebo once every 4 to 6 hours for 3 days" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Tapentadol IR 50 mg", "FlowGroupDescription":"Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Tapentadol IR 75 mg", "FlowGroupDescription":"Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"114" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"121" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"117" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"69" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"105" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"99" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"45" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"18" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"7" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"44" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"14" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"10" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Reason not specified", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"Each participant received matching placebo once every 4 to 6 hours for 3 days" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Tapentadol IR 50 mg", "BaselineGroupDescription":"Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Tapentadol IR 75 mg", "BaselineGroupDescription":"Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"114" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"121" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"117" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"352" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"51.3", "BaselineMeasurementSpread":"11.62" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"51.8", "BaselineMeasurementSpread":"11.9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"50.7", "BaselineMeasurementSpread":"13.45" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"51.3", "BaselineMeasurementSpread":"12.33" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"109" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"114" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"108" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"331" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"21" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Korea, Republic Of", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"114" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"121" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"117" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"352" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"<65 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"103" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"105" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"99" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"307" } ] } } ] } },{ "BaselineClassTitle":">=65 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"45" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Sum of Pain Intensity Differences (SPID) Over 48 Hours", "OutcomeMeasureDescription":"Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.", "OutcomeMeasurePopulationDescription":"Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"48 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Each participant received matching placebo once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Tapentadol IR 50 mg", "OutcomeGroupDescription":"Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Tapentadol IR 75 mg", "OutcomeGroupDescription":"Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"114" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"121" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"117" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"65.3", "OutcomeMeasurementSpread":"121.04" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"131.7", "OutcomeMeasurementSpread":"107.19" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"154.5", "OutcomeMeasurementSpread":"124.03" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisPValueComment":"P-value adjusted for multiple treatment group comparisons using the Hochberg method.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"76.35", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"51.0", "OutcomeAnalysisCIUpperLimit":"101.7", "OutcomeAnalysisEstimateComment":"Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisPValueComment":"P-value is adjusted for multiple treatment group comparisons using the Hochberg method.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"90.60", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"65.1", "OutcomeAnalysisCIUpperLimit":"116.1", "OutcomeAnalysisEstimateComment":"Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to First Rescue Medication Use", "OutcomeMeasureDescription":"Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.", "OutcomeMeasurePopulationDescription":"Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"Hours", "OutcomeMeasureTimeFrame":"Up to 48 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Each participant received matching placebo once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Tapentadol IR 50 mg", "OutcomeGroupDescription":"Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Tapentadol IR 75 mg", "OutcomeGroupDescription":"Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"114" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"121" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"117" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementLowerLimit":"6.7", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent of participants (38.6 percent) used rescue medication." },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent of participants (14.0 percent) used rescue medication." },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementLowerLimit":"NA", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent of participants (9.4 percent) used rescue medication." } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisPValueComment":"P-value adjusted for multiple treatment group comparisons using the Hochberg method.", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Stratified by center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisPValueComment":"P-value adjusted for multiple treatment group comparisons using the Hochberg method.", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Stratified by center" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours", "OutcomeMeasureDescription":"Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.", "OutcomeMeasurePopulationDescription":"Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"Percentage Reduction", "OutcomeMeasureTimeFrame":"Baseline (Day 1) and 12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Each participant received matching placebo once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Tapentadol IR 50 mg", "OutcomeGroupDescription":"Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Tapentadol IR 75 mg", "OutcomeGroupDescription":"Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"114" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"121" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"117" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"12 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"30.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28.6", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"50.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"28.6", "OutcomeMeasurementLowerLimit":"12.5", "OutcomeMeasurementUpperLimit":"60.0" } ] } } ] } },{ "OutcomeClassTitle":"24 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"50.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"44.4", "OutcomeMeasurementLowerLimit":"22.2", "OutcomeMeasurementUpperLimit":"60.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"50.0", "OutcomeMeasurementLowerLimit":"25.0", "OutcomeMeasurementUpperLimit":"71.4" } ] } } ] } },{ "OutcomeClassTitle":"48 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"41.4", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"71.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"66.7", "OutcomeMeasurementLowerLimit":"42.9", "OutcomeMeasurementUpperLimit":"80.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"70.0", "OutcomeMeasurementLowerLimit":"40", "OutcomeMeasurementUpperLimit":"83.3" } ] } } ] } },{ "OutcomeClassTitle":"72 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"60.0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"85.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"77.8", "OutcomeMeasurementLowerLimit":"57.1", "OutcomeMeasurementUpperLimit":"90.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"80.0", "OutcomeMeasurementLowerLimit":"50.0", "OutcomeMeasurementUpperLimit":"90.0" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Between-group comparison of cumulative distributions of percent reduction" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Between-group comparison of cumulative distributions of percent reduction" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.001", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Between-group comparison of cumulative distributions of percent reduction" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Between-group comparison of cumulative distributions of percent reduction" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"48 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Between-group comparison of cumulative distributions of percent reduction" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"48 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Between-group comparison of cumulative distributions of percent reduction" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.001", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Between-group comparison of cumulative distributions of percent reduction" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Between-group comparison of cumulative distributions of percent reduction" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours", "OutcomeMeasureDescription":"Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.", "OutcomeMeasurePopulationDescription":"Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Each participant received matching placebo once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Tapentadol IR 50 mg", "OutcomeGroupDescription":"Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Tapentadol IR 75 mg", "OutcomeGroupDescription":"Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"114" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"121" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"117" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"12 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"27.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"47.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"49.6" } ] } } ] } },{ "OutcomeClassTitle":"24 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"39.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"68.6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"70.9" } ] } } ] } },{ "OutcomeClassTitle":"48 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"53.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"79.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"76.9" } ] } } ] } },{ "OutcomeClassTitle":"72 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"57.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"81.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"80.3" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"48 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"48 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours", "OutcomeMeasureDescription":"Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.", "OutcomeMeasurePopulationDescription":"Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Each participant received matching placebo once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Tapentadol IR 50 mg", "OutcomeGroupDescription":"Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Tapentadol IR 75 mg", "OutcomeGroupDescription":"Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"114" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"121" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"117" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"12 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"32.5" } ] } } ] } },{ "OutcomeClassTitle":"24 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"46.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"54.7" } ] } } ] } },{ "OutcomeClassTitle":"48 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"48.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"71.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"70.1" } ] } } ] } },{ "OutcomeClassTitle":"72 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"56.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"79.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"76.9" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.021", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"48 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"48 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisStatisticalComment":"Controlling for center" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours", "OutcomeMeasureDescription":"Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.", "OutcomeMeasurePopulationDescription":"Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"12, 24, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Each participant received matching placebo once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Tapentadol IR 50 mg", "OutcomeGroupDescription":"Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Tapentadol IR 75 mg", "OutcomeGroupDescription":"Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"114" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"121" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"117" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"12 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.7", "OutcomeMeasurementSpread":"23.59" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"20.4", "OutcomeMeasurementSpread":"22.29" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"24.6", "OutcomeMeasurementSpread":"28.18" } ] } } ] } },{ "OutcomeClassTitle":"24 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17.7", "OutcomeMeasurementSpread":"51.88" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"48.1", "OutcomeMeasurementSpread":"47.92" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"60.1", "OutcomeMeasurementSpread":"58.56" } ] } } ] } },{ "OutcomeClassTitle":"72 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"127.9", "OutcomeMeasurementSpread":"198.61" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"234.5", "OutcomeMeasurementSpread":"170.84" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"264.1", "OutcomeMeasurementSpread":"192.70" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"16.52", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"11.1", "OutcomeAnalysisCIUpperLimit":"22.0", "OutcomeAnalysisEstimateComment":"Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"19.11", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"13.6", "OutcomeAnalysisCIUpperLimit":"24.6", "OutcomeAnalysisEstimateComment":"Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"34.71", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"23.2", "OutcomeAnalysisCIUpperLimit":"46.2", "OutcomeAnalysisEstimateComment":"Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"43.04", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"31.5", "OutcomeAnalysisCIUpperLimit":"54.6", "OutcomeAnalysisEstimateComment":"Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"122.32", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"81.8", "OutcomeAnalysisCIUpperLimit":"162.9", "OutcomeAnalysisEstimateComment":"Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"138.57", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"97.8", "OutcomeAnalysisCIUpperLimit":"179.4", "OutcomeAnalysisEstimateComment":"Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours", "OutcomeMeasureDescription":"Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72 hours. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.", "OutcomeMeasurePopulationDescription":"Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Each participant received matching placebo once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Tapentadol IR 50 mg", "OutcomeGroupDescription":"Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Tapentadol IR 75 mg", "OutcomeGroupDescription":"Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"114" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"121" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"117" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"12 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.8", "OutcomeMeasurementSpread":"7.21" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.0", "OutcomeMeasurementSpread":"8.94" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"15.1", "OutcomeMeasurementSpread":"9.99" } ] } } ] } },{ "OutcomeClassTitle":"24 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"19.4", "OutcomeMeasurementSpread":"16.91" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"34.5", "OutcomeMeasurementSpread":"19.04" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"35.1", "OutcomeMeasurementSpread":"19.50" } ] } } ] } },{ "OutcomeClassTitle":"48 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"53.8", "OutcomeMeasurementSpread":"44.60" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"88.4", "OutcomeMeasurementSpread":"40.24" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"87.6", "OutcomeMeasurementSpread":"41.34" } ] } } ] } },{ "OutcomeClassTitle":"72 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"94.7", "OutcomeMeasurementSpread":"76.12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"151.3", "OutcomeMeasurementSpread":"64.14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"148.5", "OutcomeMeasurementSpread":"65.29" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"7.15", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"5.0", "OutcomeAnalysisCIUpperLimit":"9.3", "OutcomeAnalysisEstimateComment":"Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"7.13", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"4.9", "OutcomeAnalysisCIUpperLimit":"9.3", "OutcomeAnalysisEstimateComment":"Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"15.21", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"10.6", "OutcomeAnalysisCIUpperLimit":"19.8", "OutcomeAnalysisEstimateComment":"Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"15.54", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"10.9", "OutcomeAnalysisCIUpperLimit":"20.2", "OutcomeAnalysisEstimateComment":"Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"48 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"34.76", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"24.3", "OutcomeAnalysisCIUpperLimit":"45.3", "OutcomeAnalysisEstimateComment":"Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"48 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"33.60", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"23.0", "OutcomeAnalysisCIUpperLimit":"44.2", "OutcomeAnalysisEstimateComment":"Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"56.59", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"39.4", "OutcomeAnalysisCIUpperLimit":"73.8", "OutcomeAnalysisEstimateComment":"Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"53.48", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"36.2", "OutcomeAnalysisCIUpperLimit":"70.8", "OutcomeAnalysisEstimateComment":"Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours", "OutcomeMeasureDescription":"Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.", "OutcomeMeasurePopulationDescription":"Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Scores on a scale", "OutcomeMeasureTimeFrame":"12, 24, 48, and 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Each participant received matching placebo once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Tapentadol IR 50 mg", "OutcomeGroupDescription":"Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Tapentadol IR 75 mg", "OutcomeGroupDescription":"Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"114" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"121" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"117" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"12 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13.6", "OutcomeMeasurementSpread":"29.13" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"35.4", "OutcomeMeasurementSpread":"28.74" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"39.7", "OutcomeMeasurementSpread":"36.18" } ] } } ] } },{ "OutcomeClassTitle":"24 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"37.1", "OutcomeMeasurementSpread":"65.27" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"82.6", "OutcomeMeasurementSpread":"61.99" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"95.2", "OutcomeMeasurementSpread":"74.14" } ] } } ] } },{ "OutcomeClassTitle":"48 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"119.1", "OutcomeMeasurementSpread":"159.28" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"220.2", "OutcomeMeasurementSpread":"137.54" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"242.1", "OutcomeMeasurementSpread":"157.04" } ] } } ] } },{ "OutcomeClassTitle":"72 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"222.6", "OutcomeMeasurementSpread":"265.92" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"385.7", "OutcomeMeasurementSpread":"220.15" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"412.6", "OutcomeMeasurementSpread":"244.92" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"23.66", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"16.4", "OutcomeAnalysisCIUpperLimit":"30.9", "OutcomeAnalysisEstimateComment":"Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"12 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"26.24", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"18.9", "OutcomeAnalysisCIUpperLimit":"33.6", "OutcomeAnalysisEstimateComment":"Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"49.93", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"34.4", "OutcomeAnalysisCIUpperLimit":"65.4", "OutcomeAnalysisEstimateComment":"Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"24 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"58.58", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"43.0", "OutcomeAnalysisCIUpperLimit":"74.2", "OutcomeAnalysisEstimateComment":"Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"48 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"111.12", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCILowerLimit":"76.3", "OutcomeAnalysisCIUpperLimit":"145.9", "OutcomeAnalysisEstimateComment":"Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"48 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"124.21", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"89.2", "OutcomeAnalysisCIUpperLimit":"159.2", "OutcomeAnalysisEstimateComment":"Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"178.91", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"122.4", "OutcomeAnalysisCIUpperLimit":"235.4", "OutcomeAnalysisEstimateComment":"Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisGroupDescription":"72 hours", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.001", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"ANCOVA with treatment group and center as factors and baseline pain intensity as covariate", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"192.05", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"135.2", "OutcomeAnalysisCIUpperLimit":"248.9", "OutcomeAnalysisEstimateComment":"Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Patient Global Impression of Change (PGI-C) Score at 72 Hours", "OutcomeMeasureDescription":"The PGI-C is a 7-point scale that requires the patients to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. 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