{ "FullStudy":{ "Rank":218061, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513239", "OrgStudyIdInfo":{ "OrgStudyId":"3415A-002" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"132231", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"JAPIC-CTI" },{ "SecondaryId":"2011-004994-94", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Merck Sharp & Dohme Corp.", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)", "OfficialTitle":"A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to Clostridium Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium Difficile Toxin A and B) in Patients Receiving Antibiotic Therapy for Clostridium Difficile Infection (MODIFY II)", "Acronym":"MODIFY II" }, "StatusModule":{ "StatusVerifiedDate":"August 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 1, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 22, 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 22, 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"October 24, 2016", "ResultsFirstSubmitQCDate":"October 24, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"December 15, 2016", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 6, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 5, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Merck Sharp & Dohme Corp.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"MK-3415A is the combination of monoclonal antibodies to Clostridium (C.) difficile toxin A (MK-3415) and toxin B (MK-6072). This study will investigate whether: 1) treatment with MK-6072 or MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium Difficile Infection (CDI) recurrence compared with placebo; and 2) MK-6072 and MK-3415A will be generally well tolerated in participants receiving SOC therapy for CDI compared with placebo.", "DetailedDescription":"An extended 9-month follow-up to assess for CDI recurrence through Month 12 will be conducted in a subset of participants." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Clostridium Difficile Infection" ] }, "KeywordList":{ "Keyword":[ "Clostridium difficile", "Clostridium difficile infection (CDI)", "recurrent Clostridium difficile", "vancomycin", "metronidazole", "monoclonal antibody" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"1203", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"MK-6072 + SOC", "ArmGroupType":"Experimental", "ArmGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-6072 + Standard of Care (SOC) for CDI", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: MK-6072", "Drug: SOC" ] } },{ "ArmGroupLabel":"MK-3415A + SOC", "ArmGroupType":"Experimental", "ArmGroupDescription":"Single IV infusion of 10 mg/kg MK-3415A + SOC for CDI", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: MK-3415A", "Drug: SOC" ] } },{ "ArmGroupLabel":"Placebo + SOC", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Placebo", "Drug: SOC" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"MK-6072", "InterventionDescription":"Single IV infusion of MK-6072 (10 mg/kg of monoclonal antibody to C. difficile Toxin B)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "MK-6072 + SOC" ] } },{ "InterventionType":"Biological", "InterventionName":"MK-3415A", "InterventionDescription":"Single IV infusion of MK-3415A (10 mg/kg of monoclonal antibody to C. difficile Toxin A and 10 mg/kg of monoclonal antibody to C. difficile Toxin B)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "MK-3415A + SOC" ] } },{ "InterventionType":"Biological", "InterventionName":"Placebo", "InterventionDescription":"Single IV infusion of normal saline (0.9% sodium chloride)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo + SOC" ] } },{ "InterventionType":"Drug", "InterventionName":"SOC", "InterventionDescription":"SOC for CDI will be prescribed for 10 to 14 days and can begin on the day of study drug infusion; but the first dose must have been administered prior to or within a few hours following study drug infusion. SOC is defined as the receipt of oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "MK-3415A + SOC", "MK-6072 + SOC", "Placebo + SOC" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Participants With CDI Recurrence", "PrimaryOutcomeDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile after clinical cure of the initial CDI episode. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.", "PrimaryOutcomeTimeFrame":"12 weeks" },{ "PrimaryOutcomeMeasure":"Percentage of Participants With One or More Adverse Events During 4 Weeks Following Infusion Treatment", "PrimaryOutcomeDescription":"An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.", "PrimaryOutcomeTimeFrame":"Up to 4 weeks" },{ "PrimaryOutcomeMeasure":"Percentage of Participants With One or More Drug-related Adverse Events During 4 Weeks Following Infusion Treatment", "PrimaryOutcomeDescription":"An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event. A drug-related adverse event is determined by the investigator to be related to the drug.", "PrimaryOutcomeTimeFrame":"Up to 4 weeks" },{ "PrimaryOutcomeMeasure":"Percentage of Participants With One or More Serious Drug-related Adverse Events During 4 Weeks Following Infusion Treatment", "PrimaryOutcomeDescription":"A serious adverse event (SAE) is any AE occurring at any dose or during any use of the medicinal product that results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or other important medical events. A serious drug-related adverse event is determined by the investigator to be related to the drug.", "PrimaryOutcomeTimeFrame":"Up to 4 weeks" },{ "PrimaryOutcomeMeasure":"Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event During 4 Weeks Following Infusion Treatment", "PrimaryOutcomeDescription":"An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.", "PrimaryOutcomeTimeFrame":"Up to 4 weeks" },{ "PrimaryOutcomeMeasure":"Percentage of Participants With One or More Infusion-specific Adverse Events on the Day of Infusion or the Day After Infusion", "PrimaryOutcomeDescription":"An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.", "PrimaryOutcomeTimeFrame":"Up to 24 hours" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of Participants With Global Cure", "SecondaryOutcomeDescription":"Global cure is defined as the clinical cure of the initial CDI episode with no CDI recurrence through Week 12. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode", "SecondaryOutcomeDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With CDI Recurrence in Those With a History of CDI in the 6 Months Prior to Enrollment", "SecondaryOutcomeDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With CDI Recurrence in Those With the 027 Ribotype", "SecondaryOutcomeDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. The 027 ribotype is a more virulent, epidemic strain responsible for several outbreaks of disease associated with an increased risk of severity and mortality.", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With CDI Recurrence in Those With an Epidemic Strain", "SecondaryOutcomeDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. An epidemic strain includes ribotypes 027, 014, 002, 001, 106 or 020.", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With CDI Recurrence in Those With Clinically Severe CDI", "SecondaryOutcomeDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Participants with clinically severe CDI have a Zar Score greater than or equal to 2 points based on the presence of 1 or more of the following: 1) age >60 years old (1 point); 2) body temperature >38.3°C (>100°F) (1 point); 3) albumin level ˂2.5 mg/dl (1 point); 4) peripheral white blood cell count >15,000 cells/mm^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With CDI Recurrence in Those 65 Years and Older", "SecondaryOutcomeDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With CDI Recurrence in Those With Compromised Immunity", "SecondaryOutcomeDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Compromised immunity is an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.", "SecondaryOutcomeTimeFrame":"12 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nParticipant has a diagnosis of CDI defined as: a) presence of diarrhea (passage of 3 or more loose stools in 24 or fewer hours); and b) positive test for toxigenic C. difficile from a stool collected no more than 7 days before study infusion.\nParticipant is receiving SOC therapy (i.e., oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole) for CDI.\nParticipant is highly unlikely to become pregnant or to impregnate a partner by meeting at least one of the following criteria: a) females not of reproductive potential (i.e., one who has either (1) reached natural menopause, defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone [FSH] levels in the postmenopausal range, or 12 months of spontaneous amenorrhea not including cases with an underlying disease, such as anorexia nervosa, that causes amenorrhea; (2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or (3) bilateral tubal ligation); or b) participants of reproductive potential who agree to remain abstinent or use (or have their partner use) two acceptable methods of birth control (i.e., intrauterine device [IUD], diaphragm with spermicide; contraceptive sponge, condom, vasectomy and any registered and marketed hormonal contraceptives that contain an estrogen and/or progestational agent including oral, subcutaneous, intrauterine, or intramuscular agents) starting at enrollment and throughout the 12-week study.\n\nExclusion Criteria:\n\nParticipant with an uncontrolled chronic diarrheal illness such that their normal 24-hour bowel movement habit is 3 or more loose stools.\nParticipant with planned surgery for CDI within 24 hours.\nFemale participant with a positive pregnancy test in the 48 hours before infusion and pre-menopausal females who are not sterilized and therefore have the potential to bear a child who are unwilling to undergo pregnancy testing.\nFemale participant breast feeding or planning to breast feed before completion of the 12-week study.\nFemale participant planning to donate ova before completion of the 12-week study and male participants planning to impregnate or donate sperm before completion of the 12-week study.\nParticipant has previously participated in this study, has previously received MK-3415 or MK-6072 (either alone or in combination), has received a C. difficile vaccine, or has received another experimental monoclonal antibody against C. difficile toxin A or B.\nParticipant plans to donate blood and/or blood products within 6 months after infusion.\nParticipant has received immune globulin within 6 months before infusion or is planning to receive immune globulin before completion of the 12-week study.\nTreatment with SOC therapy is planned for longer than 14 days.\nParticipant has received more than a 24-hour regimen of cholestyramine, colestimide, rifaximin, or nitazoxanide within 14 days before infusion or plans to receive these medication before completion of the 12-week study period.\nParticipant plans to take medications that are given to decrease gastrointestinal peristalsis, such as loperamide (Imodium™) or diphenoxylate hydrochloride/atropine sulfate (Lomotil™) any time during the 14 days after infusion. Participants receiving opioid medications at the onset of diarrhea may be included if they are on a stable dose or if there is anticipation of a dose decrease or cessation of use.\nParticipant plans to take the probiotic Saccaromyces boulardii or plans to receive fecal transplantation therapy, or any other therapies that have been demonstrated to decrease CDI recurrence at any time after infusion (Day 1) and through completion of the 12-week study period.\nParticipant has received another investigational study agent within the past 30 days or is currently participating in or scheduled to participate in any other clinical study with an investigational agent during the 12-week study.\nParticipant is not expected to survive for 72 hours.\nParticipant has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant, would make it unlikely for the participant to complete the study, or would confound the results of the study.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Medical Director", "OverallOfficialAffiliation":"Merck Sharp & Dohme Corp.", "OverallOfficialRole":"Study Director" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"31883370", "ReferenceType":"derived", "ReferenceCitation":"Goldstein EJC, Citron DM, Gerding DN, Wilcox MH, Gabryelski L, Pedley A, Zeng Z, Dorr MB. Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: 12-Month Observational Data From the Randomized Phase III Trial, MODIFY II. Clin Infect Dis. 2019 Dec 23. pii: ciz1151. doi: 10.1093/cid/ciz1151. [Epub ahead of print]" },{ "ReferencePMID":"31846705", "ReferenceType":"derived", "ReferenceCitation":"Zeng Z, Zhao H, Dorr MB, Shen J, Wilcox MH, Poxton IR, Guris D, Li J, Shaw PM. Bezlotoxumab for prevention of Clostridium difficile infection recurrence: Distinguishing relapse from reinfection with whole genome sequencing. Anaerobe. 2020 Feb;61:102137. doi: 10.1016/j.anaerobe.2019.102137. Epub 2019 Dec 14." },{ "ReferencePMID":"30460321", "ReferenceType":"derived", "ReferenceCitation":"Basu A, Prabhu VS, Dorr MB, Golan Y, Dubberke ER, Cornely OA, Heimann SM, Pedley A, Xu R, Hanson ME, Marcella S. Bezlotoxumab Is Associated With a Reduction in Cumulative Inpatient-Days: Analysis of the Hospitalization Data From the MODIFY I and II Clinical Trials. Open Forum Infect Dis. 2018 Nov 15;5(11):ofy218. doi: 10.1093/ofid/ofy218. eCollection 2018 Nov." },{ "ReferencePMID":"30455246", "ReferenceType":"derived", "ReferenceCitation":"Yee KL, Kleijn HJ, Kerbusch T, Matthews RP, Dorr MB, Garey KW, Wrishko RE. Population Pharmacokinetics and Pharmacodynamics of Bezlotoxumab in Adults with Primary and Recurrent Clostridium difficile Infection. Antimicrob Agents Chemother. 2019 Jan 29;63(2). pii: e01971-18. doi: 10.1128/AAC.01971-18. Print 2019 Feb." },{ "ReferencePMID":"30227108", "ReferenceType":"derived", "ReferenceCitation":"Kelly CP, Wilcox MH, Glerup H, Aboo N, Ellison MC, Eves K, Dorr MB. Bezlotoxumab for Clostridium difficile Infection Complicating Inflammatory Bowel Disease. Gastroenterology. 2018 Oct;155(4):1270-1271. doi: 10.1053/j.gastro.2018.06.080. Epub 2018 Sep 15." },{ "ReferencePMID":"30060024", "ReferenceType":"derived", "ReferenceCitation":"Prabhu VS, Cornely OA, Golan Y, Dubberke ER, Heimann SM, Hanson ME, Liao J, Pedley A, Dorr MB, Marcella S. Thirty-Day Readmissions in Hospitalized Patients Who Received Bezlotoxumab With Antibacterial Drug Treatment for Clostridium difficile Infection. Clin Infect Dis. 2017 Oct 1;65(7):1218-1221. doi: 10.1093/cid/cix523." },{ "ReferencePMID":"29788418", "ReferenceType":"derived", "ReferenceCitation":"Birch T, Golan Y, Rizzardini G, Jensen E, Gabryelski L, Guris D, Dorr MB. Efficacy of bezlotoxumab based on timing of administration relative to start of antibacterial therapy for Clostridium difficile infection. J Antimicrob Chemother. 2018 Sep 1;73(9):2524-2528. doi: 10.1093/jac/dky182." },{ "ReferencePMID":"29538686", "ReferenceType":"derived", "ReferenceCitation":"Gerding DN, Kelly CP, Rahav G, Lee C, Dubberke ER, Kumar PN, Yacyshyn B, Kao D, Eves K, Ellison MC, Hanson ME, Guris D, Dorr MB. Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection in Patients at Increased Risk for Recurrence. Clin Infect Dis. 2018 Aug 16;67(5):649-656. doi: 10.1093/cid/ciy171." },{ "ReferencePMID":"28121498", "ReferenceType":"derived", "ReferenceCitation":"Wilcox MH, Gerding DN, Poxton IR, Kelly C, Nathan R, Birch T, Cornely OA, Rahav G, Bouza E, Lee C, Jenkin G, Jensen W, Kim YS, Yoshida J, Gabryelski L, Pedley A, Eves K, Tipping R, Guris D, Kartsonis N, Dorr MB; MODIFY I and MODIFY II Investigators. Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection. N Engl J Med. 2017 Jan 26;376(4):305-317. doi: 10.1056/NEJMoa1602615." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Yes", "IPDSharingDescription":"https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf", "IPDSharingURL":"http://engagezone.msd.com/ds_documentation.php" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"Male and female participants 18 years of age or older, diagnosed with Clostridium difficile infection (CDI) and receiving Standard of Care (SOC) therapy were recruited for this trial.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"MK-3415A + SOC", "FlowGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"MK-6072 + SOC", "FlowGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Placebo + SOC", "FlowGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" },{ "FlowGroupId":"FG003", "FlowGroupTitle":"MK-3415A + SOC 9-ME", "FlowGroupDescription":"9 Month Extension (9-ME) for participants treated with a single IV infusion of 10 mg/kg MK-3415A + SOC" },{ "FlowGroupId":"FG004", "FlowGroupTitle":"MK-6072 + SOC 9-ME", "FlowGroupDescription":"9-ME for participants treated with a single IV infusion of 10 mg/kg MK-6072 + SOC" },{ "FlowGroupId":"FG005", "FlowGroupTitle":"Placebo + SOC 9-ME", "FlowGroupDescription":"9-ME for participants treated with Placebo" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Period 1: Main Phase", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Randomized participants", "FlowAchievementNumSubjects":"397" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Randomized participants", "FlowAchievementNumSubjects":"407" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementComment":"Randomized participants", "FlowAchievementNumSubjects":"399" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"Treated", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Treated participants", "FlowAchievementNumSubjects":"391" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Treated participants", "FlowAchievementNumSubjects":"396" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementComment":"Treated participants", "FlowAchievementNumSubjects":"381" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"All Participants as Treated", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"One participant randomized to receive MK-3415A (MK-3415 plus MK-6072) received only MK-3415", "FlowAchievementNumSubjects":"390" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Treatment actually received", "FlowAchievementNumSubjects":"396" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementComment":"Treatment actually received", "FlowAchievementNumSubjects":"381" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"322" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"337" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"311" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"75" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"70" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"88" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"29" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"22" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"32" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"11" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"10" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"6" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Physician Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Technical Problems", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"27" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"29" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"42" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"Period 2: 9 Month Extension Phase", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"112" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"100" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"83" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"102" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"90" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"78" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"10" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"10" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"5" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"5" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"5" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Physician Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Technical Problems", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"All Randomized Participants", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"MK-3415A + SOC", "BaselineGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"MK-6072 + SOC", "BaselineGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Placebo + SOC", "BaselineGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"397" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"407" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"399" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"1203" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"65.9", "BaselineMeasurementSpread":"17.3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"62.6", "BaselineMeasurementSpread":"17.5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"64.3", "BaselineMeasurementSpread":"16.4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"64.2", "BaselineMeasurementSpread":"17.1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"216" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"220" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"239" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"675" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"181" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"187" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"160" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"528" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With CDI Recurrence", "OutcomeMeasureDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile after clinical cure of the initial CDI episode. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.", "OutcomeMeasurePopulationDescription":"The (Full Analysis Set) FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"390" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"395" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"378" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"25.7" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Adjusted Difference", "OutcomeAnalysisParamValue":"-10.7", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-16.4", "OutcomeAnalysisCIUpperLimit":"-5.1", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus Placebo + SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0003", "OutcomeAnalysisPValueComment":"One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Adjusted Difference", "OutcomeAnalysisParamValue":"-9.9", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-15.5", "OutcomeAnalysisCIUpperLimit":"-4.3", "OutcomeAnalysisEstimateComment":"MK-6072 + SOC minus Placebo + SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.3718", "OutcomeAnalysisPValueComment":"One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Adjusted Difference", "OutcomeAnalysisParamValue":"-0.8", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-5.9", "OutcomeAnalysisCIUpperLimit":"4.2", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus MK-6072 + SOC" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Global Cure", "OutcomeMeasureDescription":"Global cure is defined as the clinical cure of the initial CDI episode with no CDI recurrence through Week 12. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.", "OutcomeMeasurePopulationDescription":"The FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"390" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"395" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"378" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"57.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"66.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"52.1" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0722", "OutcomeAnalysisPValueComment":"One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Adjusted Difference", "OutcomeAnalysisParamValue":"5.2", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-1.8", "OutcomeAnalysisCIUpperLimit":"12.2", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus Placebo + SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Adjusted Difference", "OutcomeAnalysisParamValue":"14.6", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"7.7", "OutcomeAnalysisCIUpperLimit":"21.4", "OutcomeAnalysisEstimateComment":"MK-6072 + SOC minus Placebo + SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.9969", "OutcomeAnalysisPValueComment":"One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Adjusted Difference", "OutcomeAnalysisParamValue":"-9.4", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-16.1", "OutcomeAnalysisCIUpperLimit":"-2.7", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus MK-6072 + SOC" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode", "OutcomeMeasureDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.", "OutcomeMeasurePopulationDescription":"Treated participants who achieved a clinical cure of the initial CDI episode.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"282" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"326" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"294" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"19.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"33.0" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0006", "OutcomeAnalysisPValueComment":"One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Adjusted Difference", "OutcomeAnalysisParamValue":"-11.9", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-19.0", "OutcomeAnalysisCIUpperLimit":"-4.7", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus Placebo + SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisPValueComment":"One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Adjusted Difference", "OutcomeAnalysisParamValue":"-13.7", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-20.4", "OutcomeAnalysisCIUpperLimit":"-6.9", "OutcomeAnalysisEstimateComment":"MK-6072 + SOC minus Placebo + SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.6962", "OutcomeAnalysisPValueComment":"One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Adjusted Difference", "OutcomeAnalysisParamValue":"1.6", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-4.6", "OutcomeAnalysisCIUpperLimit":"8.0", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus MK-6072 + SOC" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With One or More Adverse Events During 4 Weeks Following Infusion Treatment", "OutcomeMeasureDescription":"An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.", "OutcomeMeasurePopulationDescription":"All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK- 3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Up to 4 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"390" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"396" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"381" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"57.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"58.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"60.4" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.408", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Difference in Percentages", "OutcomeAnalysisParamValue":"-2.9", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-9.8", "OutcomeAnalysisCIUpperLimit":"4.0", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus Placebo +SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.517", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Difference in Percentages", "OutcomeAnalysisParamValue":"-2.3", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-9.2", "OutcomeAnalysisCIUpperLimit":"4.6", "OutcomeAnalysisEstimateComment":"MK-6072 + SOC minus Placebo + SOC" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With One or More Drug-related Adverse Events During 4 Weeks Following Infusion Treatment", "OutcomeMeasureDescription":"An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event. A drug-related adverse event is determined by the investigator to be related to the drug.", "OutcomeMeasurePopulationDescription":"APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Up to 4 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"390" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"396" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"381" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6.8" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.931", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Difference in Percentages", "OutcomeAnalysisParamValue":"-0.2", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-3.8", "OutcomeAnalysisCIUpperLimit":"3.5", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus Placebo + SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.997", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Difference in Percentages", "OutcomeAnalysisParamValue":"0.0", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-3.7", "OutcomeAnalysisCIUpperLimit":"3.6", "OutcomeAnalysisEstimateComment":"MK-6072 + SOC minus Placebo + SOC" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With One or More Serious Drug-related Adverse Events During 4 Weeks Following Infusion Treatment", "OutcomeMeasureDescription":"A serious adverse event (SAE) is any AE occurring at any dose or during any use of the medicinal product that results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or other important medical events. A serious drug-related adverse event is determined by the investigator to be related to the drug.", "OutcomeMeasurePopulationDescription":"APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Up to 4 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"390" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"396" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"381" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.3" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.328", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Difference in Percentages", "OutcomeAnalysisParamValue":"0.5", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.8", "OutcomeAnalysisCIUpperLimit":"2.0", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus Placebo + SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.308", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Difference in Percentages", "OutcomeAnalysisParamValue":"-0.3", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-1.5", "OutcomeAnalysisCIUpperLimit":"0.7", "OutcomeAnalysisEstimateComment":"MK-6072 + SOC minus Placebo + SOC" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event During 4 Weeks Following Infusion Treatment", "OutcomeMeasureDescription":"An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.", "OutcomeMeasurePopulationDescription":"APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Up to 4 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"390" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"396" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"381" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":">0.999", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Difference in Percentages", "OutcomeAnalysisParamValue":"0.0", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-1.0", "OutcomeAnalysisCIUpperLimit":"1.0", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus Placebo + SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":">0.999", "OutcomeAnalysisStatisticalMethod":"Miettinen and Nurminen", "OutcomeAnalysisParamType":"Difference in Percentages", "OutcomeAnalysisParamValue":"0.0", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-1.0", "OutcomeAnalysisCIUpperLimit":"1.0", "OutcomeAnalysisEstimateComment":"MK-6072 + SOC minus Placebo + SOC" } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With One or More Infusion-specific Adverse Events on the Day of Infusion or the Day After Infusion", "OutcomeMeasureDescription":"An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.", "OutcomeMeasurePopulationDescription":"APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Up to 24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"390" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"396" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"381" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7.6" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Difference in Percentages", "OutcomeAnalysisParamValue":"-0.4", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-4.2", "OutcomeAnalysisCIUpperLimit":"3.3", "OutcomeAnalysisEstimateComment":"MK-3415A + SOC minus Placebo + SOC" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Difference in Percentages", "OutcomeAnalysisParamValue":"1.2", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-2.7", "OutcomeAnalysisCIUpperLimit":"5.2", "OutcomeAnalysisEstimateComment":"MK-6072 + SOC minus Placebo + SOC" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With CDI Recurrence in Those With a History of CDI in the 6 Months Prior to Enrollment", "OutcomeMeasureDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.", "OutcomeMeasurePopulationDescription":"Treated participants with a history of CDI in the past 6 months.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"104" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"113" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"110" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"23.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"42.7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With CDI Recurrence in Those With the 027 Ribotype", "OutcomeMeasureDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. The 027 ribotype is a more virulent, epidemic strain responsible for several outbreaks of disease associated with an increased risk of severity and mortality.", "OutcomeMeasurePopulationDescription":"Treated participants with the 027 ribotype", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"39" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"64" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"20.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"32.8" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With CDI Recurrence in Those With an Epidemic Strain", "OutcomeMeasureDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. An epidemic strain includes ribotypes 027, 014, 002, 001, 106 or 020.", "OutcomeMeasurePopulationDescription":"Treated participants with an epidemic strain", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"116" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"102" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"127" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"18.6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"29.1" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With CDI Recurrence in Those With Clinically Severe CDI", "OutcomeMeasureDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Participants with clinically severe CDI have a Zar Score greater than or equal to 2 points based on the presence of 1 or more of the following: 1) age >60 years old (1 point); 2) body temperature >38.3°C (>100°F) (1 point); 3) albumin level ˂2.5 mg/dl (1 point); 4) peripheral white blood cell count >15,000 cells/mm^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).", "OutcomeMeasurePopulationDescription":"Treated participants with clinically severe CDI", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"80" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"55" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"65" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"20.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With CDI Recurrence in Those 65 Years and Older", "OutcomeMeasureDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.", "OutcomeMeasurePopulationDescription":"Treated participants 65 years and older.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"241" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"205" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"206" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"29.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With CDI Recurrence in Those With Compromised Immunity", "OutcomeMeasureDescription":"CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Compromised immunity is an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.", "OutcomeMeasurePopulationDescription":"Treated participants with compromised immunity", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"12 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"MK-3415A + SOC", "OutcomeGroupDescription":"Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"MK-6072 + SOC", "OutcomeGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Placebo + SOC", "OutcomeGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"85" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"91" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"61" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"26.2" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Non-serious adverse events up to Day 28; serious adverse events up to Day 90", "EventsDescription":"Main Phase AEs were assessed Systematically: All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm was treated with MK-3415, but was not treated with MK-6072, is placed in his own arm for MK-3415 (not a randomized arm for this study).\n\n9-Month Extension AEs were not planned for collection; and were therefore assessed Non-systematically.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"MK-3415A + SOC", "EventGroupDescription":"Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI", "EventGroupDeathsNumAffected":"31", "EventGroupDeathsNumAtRisk":"390", "EventGroupSeriousNumAffected":"118", "EventGroupSeriousNumAtRisk":"390", "EventGroupOtherNumAffected":"37", "EventGroupOtherNumAtRisk":"390" },{ "EventGroupId":"EG001", "EventGroupTitle":"MK-6072 + SOC", "EventGroupDescription":"Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI", "EventGroupDeathsNumAffected":"25", "EventGroupDeathsNumAtRisk":"396", "EventGroupSeriousNumAffected":"111", "EventGroupSeriousNumAtRisk":"396", "EventGroupOtherNumAffected":"44", "EventGroupOtherNumAtRisk":"396" },{ "EventGroupId":"EG002", "EventGroupTitle":"Placebo + SOC", "EventGroupDescription":"Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI", "EventGroupDeathsNumAffected":"33", "EventGroupDeathsNumAtRisk":"381", "EventGroupSeriousNumAffected":"129", "EventGroupSeriousNumAtRisk":"381", "EventGroupOtherNumAffected":"37", "EventGroupOtherNumAtRisk":"381" },{ "EventGroupId":"EG003", "EventGroupTitle":"MK-3415 + SOC", "EventGroupDescription":"Single IV infusion of 10 mg/kg MK-3415 + SOC for CDI", "EventGroupDeathsNumAffected":"1", "EventGroupDeathsNumAtRisk":"1", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"1", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"1" },{ "EventGroupId":"EG004", "EventGroupTitle":"MK-3415A + SOC 9-ME", "EventGroupDescription":"9 Month Extension (9-ME) for participants treated with a single IV infusion of 10 mg/kg MK-3415A + SOC", "EventGroupDeathsNumAffected":"2", "EventGroupDeathsNumAtRisk":"112", "EventGroupSeriousNumAffected":"6", "EventGroupSeriousNumAtRisk":"112", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"112" },{ "EventGroupId":"EG005", "EventGroupTitle":"MK-6072 + SOC 9-ME", "EventGroupDescription":"9-ME for participants treated with a single IV infusion of 10 mg/kg MK-6072 + SOC", "EventGroupDeathsNumAffected":"5", "EventGroupDeathsNumAtRisk":"100", "EventGroupSeriousNumAffected":"7", "EventGroupSeriousNumAtRisk":"100", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"100" },{ "EventGroupId":"EG006", "EventGroupTitle":"Placebo + SOC 9-ME", "EventGroupDescription":"9-ME for participants treated with Placebo", "EventGroupDeathsNumAffected":"2", "EventGroupDeathsNumAtRisk":"83", "EventGroupSeriousNumAffected":"3", "EventGroupSeriousNumAtRisk":"83", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"83" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Anaemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Anaemia of malignant disease", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Coagulopathy", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Disseminated intravascular coagulation", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Febrile neutropenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Haemolytic anaemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Haemorrhagic anaemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Leukopenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Neutropenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Sickle cell anaemia with crisis", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Acute coronary syndrome", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Acute myocardial infarction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Angina unstable", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Arrhythmia", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Arteriosclerosis coronary artery", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Atrial fibrillation", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Atrial flutter", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Bradycardia", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cardiac arrest", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cardiac disorder", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cardiac failure", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cardiac failure acute", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cardiac failure chronic", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cardiac failure congestive", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cardio-respiratory arrest", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Myocardial infarction", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Prinzmetal angina", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Supraventricular tachycardia", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hyperparathyroidism", "SeriousEventOrganSystem":"Endocrine disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hyperthyroidism", "SeriousEventOrganSystem":"Endocrine disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Blindness unilateral", "SeriousEventOrganSystem":"Eye disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Abdominal pain", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Anal fissure", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Anal fistula", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Colitis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Diarrhoea", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"7", "SeriousEventStatsNumAffected":"7", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"6", "SeriousEventStatsNumAffected":"6", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Diverticulum intestinal haemorrhagic", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Duodenal ulcer", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Dysphagia", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Gastric haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Gastrointestinal haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Gastrointestinal inflammation", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Haematochezia", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Haemorrhagic erosive gastritis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Haemorrhoids", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Ileus", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Impaired gastric emptying", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Intestinal haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Intestinal perforation", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Large intestinal haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Mesenteric artery thrombosis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Nausea", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Oesophageal ulcer", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pancreatitis acute", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Small intestinal obstruction", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Subileus", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Vomiting", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Asthenia", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Chest pain", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Death", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Device breakage", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Device malfunction", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Disuse syndrome", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Drug withdrawal syndrome", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Fatigue", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"General physical health deterioration", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Generalised oedema", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Impaired healing", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Influenza like illness", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Multi-organ failure", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Non-cardiac chest pain", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Oedema peripheral", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pelvic mass", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pyrexia", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Suprapubic pain", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cholangitis", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cholangitis acute", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cholecystitis acute", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hepatic cirrhosis", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hepatic failure", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Anaphylactic reaction", "SeriousEventOrganSystem":"Immune system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Abdominal abscess", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Anal abscess", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Arthritis infective", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Bacteraemia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Bursitis infective staphylococcal", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cellulitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Clostridium difficile infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"13", "SeriousEventStatsNumAffected":"13", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"15", "SeriousEventStatsNumAffected":"14", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"34", "SeriousEventStatsNumAffected":"28", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cytomegalovirus viraemia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Device related infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Diabetic foot infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Diverticulitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Endocarditis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Erysipelas", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Fungaemia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Gangrene", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Gastroenteritis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"HIV infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Infective spondylitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Influenza", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Kidney infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Lower respiratory tract infection viral", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Lung abscess", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Meningitis tuberculous", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Necrotising fasciitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Osteomyelitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pelvic abscess", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Periodontitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Peritonitis bacterial", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pneumonia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"9", "SeriousEventStatsNumAffected":"9", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"9", "SeriousEventStatsNumAffected":"9", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pseudomembranous colitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pyelonephritis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pyelonephritis acute", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Rhinitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Sepsis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"7", "SeriousEventStatsNumAffected":"6", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"14", "SeriousEventStatsNumAffected":"13", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Septic shock", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"6", "SeriousEventStatsNumAffected":"6", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Upper respiratory tract infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Urinary tract infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"7", "SeriousEventStatsNumAffected":"7", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"11", "SeriousEventStatsNumAffected":"9", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Urosepsis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Viraemia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Wound infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Arteriovenous fistula site haematoma", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Concussion", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Femur fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Frostbite", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hip fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Intentional overdose", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Post procedural inflammation", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Spinal compression fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Toxicity to various agents", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Alanine aminotransferase increased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Aspartate aminotransferase increased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Blood lactic acid increased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Blood pressure decreased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Escherichia test positive", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"International normalised ratio increased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Dehydration", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Diabetic ketoacidosis", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Fluid overload", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hypercreatininaemia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hyperkalaemia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hypoglycaemia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hypokalaemia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hyponatraemia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Shock hypoglycaemic", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Arthritis reactive", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Muscular weakness", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Musculoskeletal chest pain", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Soft tissue necrosis", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Acute myeloid leukaemia", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Acute myeloid leukaemia recurrent", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Adenocarcinoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Adenocarcinoma gastric", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Basal cell carcinoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Bile duct cancer", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Bone cancer", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Bone cancer metastatic", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Breast cancer metastatic", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Colon cancer", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Gastrointestinal cancer metastatic", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Glioblastoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hepatocellular carcinoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hodgkin's disease", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Leiomyosarcoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Lung adenocarcinoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Lung neoplasm", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Lymphocytic leukaemia", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Malignant melanoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Medulloblastoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Metastatic renal cell carcinoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Metastatic squamous cell carcinoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Myeloid leukaemia", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Oesophageal carcinoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pancreatic carcinoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Peripheral T-cell lymphoma unspecified", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Plasma cell myeloma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Prostate cancer", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Renal cancer metastatic", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Squamous cell carcinoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Altered state of consciousness", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Aphasia", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cerebellar haemorrhage", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cerebral haemorrhage", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cerebral infarction", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cerebral ischaemia", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Cerebrovascular accident", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Dementia", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Dizziness", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Epilepsy", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hemiparesis", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hypoxic-ischaemic encephalopathy", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Ischaemic stroke", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Loss of consciousness", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Metabolic encephalopathy", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Neuralgia", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Presyncope", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Seizure", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Senile dementia", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"0" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"0" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"0" } ] } },{ "SeriousEventTerm":"Spinal cord compression", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Status epilepticus", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Syncope", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Transient ischaemic attack", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Wernicke's encephalopathy", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Agitation", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Anxiety disorder", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Confusional state", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Mental status changes", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Acute kidney injury", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Calculus ureteric", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Chronic kidney disease", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Dysuria", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Haematuria", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Nephritic syndrome", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Urinary retention", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Prostatitis", "SeriousEventOrganSystem":"Reproductive system and breast disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Acute pulmonary oedema", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Acute respiratory failure", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Asthma", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Chronic obstructive pulmonary disease", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hypoxia", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Interstitial lung disease", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Laryngeal stenosis", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Lung disorder", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pneumonia aspiration", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pneumothorax", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pulmonary embolism", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pulmonary haemorrhage", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pulmonary oedema", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Respiratory arrest", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Respiratory depression", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Respiratory distress", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Respiratory failure", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Upper respiratory tract inflammation", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Decubitus ulcer", "SeriousEventOrganSystem":"Skin and subcutaneous tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Dermatitis allergic", "SeriousEventOrganSystem":"Skin and subcutaneous tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Skin ulcer", "SeriousEventOrganSystem":"Skin and subcutaneous tissue disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Circulatory collapse", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Deep vein thrombosis", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Dry gangrene", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hypertension", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hypertensive crisis", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Hypotension", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Orthostatic hypotension", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Peripheral arterial occlusive disease", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Peripheral ischaemia", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Phlebitis", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Shock", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Thrombophlebitis", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Encephalopathy", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Emphysematous cholecystitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA version 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Osteoporotic fracture", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA version 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Bladder cancer", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA version 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Chronic lymphocytic leukaemia", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA version 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Lymphoma", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA version 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Pancreatic carcinoma metastatic", "SeriousEventOrganSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)", "SeriousEventSourceVocabulary":"MedDRA version 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } },{ "SeriousEventTerm":"Haemorrhage intracranial", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA version 16.1", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"390" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"396" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"381" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"112" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"100" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"83" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Diarrhoea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 16.1", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"19", "OtherEventStatsNumAffected":"17", "OtherEventStatsNumAtRisk":"390" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"18", "OtherEventStatsNumAffected":"17", "OtherEventStatsNumAtRisk":"396" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"23", "OtherEventStatsNumAffected":"21", "OtherEventStatsNumAtRisk":"381" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"112" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"100" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"83" } ] } },{ "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 16.1", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"17", "OtherEventStatsNumAffected":"17", "OtherEventStatsNumAtRisk":"390" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"23", "OtherEventStatsNumAffected":"23", "OtherEventStatsNumAtRisk":"396" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"12", "OtherEventStatsNumAffected":"12", "OtherEventStatsNumAtRisk":"381" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"112" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"100" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"83" } ] } },{ "OtherEventTerm":"Clostridium difficile infection", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 16.1", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"390" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"396" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"381" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"112" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"100" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"83" } ] } },{ "OtherEventTerm":"Lymphocyte count decreased", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 16.1", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"390" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"396" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"381" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"112" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"100" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"83" } ] } },{ "OtherEventTerm":"Neutrophil count increased", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 16.1", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"390" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"396" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"381" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"112" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"100" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"83" } ] } },{ "OtherEventTerm":"White blood cell count increased", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 16.1", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"390" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"396" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"381" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"1" },{ "OtherEventStatsGroupId":"EG004", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"112" },{ "OtherEventStatsGroupId":"EG005", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"100" },{ "OtherEventStatsGroupId":"EG006", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"83" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission." }, "PointOfContact":{ "PointOfContactTitle":"Senior Vice President, Global Clinical Development", "PointOfContactOrganization":"Merck Sharp & Dohme Corp.", "PointOfContactEMail":"ClinicalTrialsDisclosure@merck.com", "PointOfContactPhone":"1-800-672-6372" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "Argentina", "Canada", "Czech Republic", "Finland", "France", "Germany", "Israel", "Japan", "Korea, Republic of", "Poland", "Russian Federation", "Spain", "Sweden", "Switzerland", "Taiwan", "Turkey", "United States" ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000007239", "ConditionMeshTerm":"Infection" },{ "ConditionMeshId":"D000003141", "ConditionMeshTerm":"Communicable Diseases" },{ "ConditionMeshId":"D000003015", "ConditionMeshTerm":"Clostridium Infections" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000016908", "ConditionAncestorTerm":"Gram-Positive Bacterial Infections" },{ "ConditionAncestorId":"D000001424", "ConditionAncestorTerm":"Bacterial Infections" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafAsFound":"Infection", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafAsFound":"Infection", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4830", "ConditionBrowseLeafName":"Clostridium Infections", "ConditionBrowseLeafAsFound":"Clostridium Difficile Infection", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3303", "ConditionBrowseLeafName":"Bacterial Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M17835", "ConditionBrowseLeafName":"Gram-Positive Bacterial Infections", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }