{ "FullStudy":{ "Rank":217551, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519921", "OrgStudyIdInfo":{ "OrgStudyId":"ML18495" }, "Organization":{ "OrgFullName":"Hoffmann-La Roche", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.", "OfficialTitle":"An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Patients With HBeAg Positive Chronic Hepatitis B" }, "StatusModule":{ "StatusVerifiedDate":"March 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2005" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2008", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2008", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 5, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"December 17, 2015", "ResultsFirstSubmitQCDate":"December 17, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"January 25, 2016", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 22, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 21, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Hoffmann-La Roche", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hepatitis B, Chronic" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"150", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"PEG-IFN alfa-2a (Treatment naïve)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: peginterferon alfa-2a [Pegasys]" ] } },{ "ArmGroupLabel":"PEG-IFN alfa-2a (YMDD mutant)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: peginterferon alfa-2a [Pegasys]" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"peginterferon alfa-2a [Pegasys]", "InterventionDescription":"Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PEG-IFN alfa-2a (Treatment naïve)", "PEG-IFN alfa-2a (YMDD mutant)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72", "PrimaryOutcomeDescription":"Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.", "PrimaryOutcomeTimeFrame":"Week 72" },{ "PrimaryOutcomeMeasure":"Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72", "PrimaryOutcomeDescription":"Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.", "PrimaryOutcomeTimeFrame":"Week 72" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of Participants With ALT Normalization At Week 48 and Week 72", "SecondaryOutcomeDescription":"Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.", "SecondaryOutcomeTimeFrame":"Week 48 and Week 72" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72", "SecondaryOutcomeDescription":"Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.", "SecondaryOutcomeTimeFrame":"Week 48 and Week 72" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With a Combined Response At Week 48 and Week 72", "SecondaryOutcomeDescription":"A responder with Combined Response was a participant with HBV-DNA<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.", "SecondaryOutcomeTimeFrame":"Week 48 and Week 72" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion", "SecondaryOutcomeDescription":"A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.", "SecondaryOutcomeTimeFrame":"Week 48 and Week 72" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72", "SecondaryOutcomeDescription":"A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.", "SecondaryOutcomeTimeFrame":"Week 48 and Week 72" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72", "SecondaryOutcomeDescription":"A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.", "SecondaryOutcomeTimeFrame":"Week 48 and Week 72" },{ "SecondaryOutcomeMeasure":"Number of Participants With Any Adverse Events and Any Serious Adverse Events", "SecondaryOutcomeDescription":"An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.", "SecondaryOutcomeTimeFrame":"Up to Week 72" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAdult patients, 18-65 years of age\nHBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve\nDetectable hepatitis B virus (HBV) DNA (>100,000 copies/mL)\n\nExclusion Criteria:\n\nCoinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)\nEvidence of decompensated liver disease\nA medical condition associated with chronic liver disease other than viral hepatitis", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Clinical Trials", "OverallOfficialAffiliation":"Hoffmann-La Roche", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Busan", "LocationZip":"49241", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Daegu", "LocationZip":"41944", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Seoul", "LocationZip":"03722", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Seoul", "LocationZip":"05505", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Seoul", "LocationZip":"06351", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Seoul", "LocationZip":"08308", "LocationCountry":"Korea, Republic of" },{ "LocationCity":"Seoul", "LocationZip":"14647", "LocationCountry":"Korea, Republic of" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"A total of 150 participants were enrolled in this study conducted from 26 October 2005 to 24 June 2008 at 7 centers in Republic of Korea.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "FlowGroupDescription":"Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "FlowGroupDescription":"Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"86" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"64" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"65" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"49" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"21" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"15" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"10" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"9" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Treatment refusal", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"High alanine aminotransferase (ALT)", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Baseline characteristics were analysed on Intent-to-treat (ITT) population which included all participants who received at least one dose of study drug. The ITT and the safety populations were identical.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "BaselineGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "BaselineGroupDescription":"Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"86" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"64" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"150" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"35.3", "BaselineMeasurementSpread":"9.20" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"36.8", "BaselineMeasurementSpread":"9.0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"35.9", "BaselineMeasurementSpread":"9.1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"33" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"63" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"54" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"117" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72", "OutcomeMeasureDescription":"Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.", "OutcomeMeasurePopulationDescription":"Intent-to-treat (ITT) population included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 72", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "OutcomeGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "OutcomeGroupDescription":"Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"86" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"64" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.9", "OutcomeMeasurementLowerLimit":"12.9", "OutcomeMeasurementUpperLimit":"31.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"21.9", "OutcomeMeasurementLowerLimit":"12.5", "OutcomeMeasurementUpperLimit":"34.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72", "OutcomeMeasureDescription":"Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.", "OutcomeMeasurePopulationDescription":"The ITT population included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 72", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "OutcomeGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "OutcomeGroupDescription":"Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"86" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"64" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.9", "OutcomeMeasurementLowerLimit":"12.9", "OutcomeMeasurementUpperLimit":"31.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"23.4", "OutcomeMeasurementLowerLimit":"13.8", "OutcomeMeasurementUpperLimit":"35.7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With ALT Normalization At Week 48 and Week 72", "OutcomeMeasureDescription":"Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.", "OutcomeMeasurePopulationDescription":"The ITT population included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48 and Week 72", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "OutcomeGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "OutcomeGroupDescription":"Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"86" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"64" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 48 (EOT)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"34.9", "OutcomeMeasurementLowerLimit":"24.9", "OutcomeMeasurementUpperLimit":"45.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"29.7", "OutcomeMeasurementLowerLimit":"18.9", "OutcomeMeasurementUpperLimit":"42.4" } ] } } ] } },{ "OutcomeClassTitle":"Week 72 (EOF)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"36.0", "OutcomeMeasurementLowerLimit":"26.0", "OutcomeMeasurementUpperLimit":"47.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"29.7", "OutcomeMeasurementLowerLimit":"18.9", "OutcomeMeasurementUpperLimit":"42.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72", "OutcomeMeasureDescription":"Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.", "OutcomeMeasurePopulationDescription":"The ITT population included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 48 and Week 72", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "OutcomeGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "OutcomeGroupDescription":"Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"86" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"64" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 48 (EOT)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.5", "OutcomeMeasurementLowerLimit":"4.9", "OutcomeMeasurementUpperLimit":"18.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.9", "OutcomeMeasurementLowerLimit":"4.5", "OutcomeMeasurementUpperLimit":"21.2" } ] } } ] } },{ "OutcomeClassTitle":"Week 72 (EOF)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.5", "OutcomeMeasurementLowerLimit":"0.7", "OutcomeMeasurementUpperLimit":"9.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"9.4", "OutcomeMeasurementLowerLimit":"3.5", "OutcomeMeasurementUpperLimit":"19.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With a Combined Response At Week 48 and Week 72", "OutcomeMeasureDescription":"A responder with Combined Response was a participant with HBV-DNA<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.", "OutcomeMeasurePopulationDescription":"The ITT population included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 48 and Week 72", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "OutcomeGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "OutcomeGroupDescription":"Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"86" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"64" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 48 (EOT)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.1", "OutcomeMeasurementLowerLimit":"3.3", "OutcomeMeasurementUpperLimit":"16.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"9.4", "OutcomeMeasurementLowerLimit":"3.5", "OutcomeMeasurementUpperLimit":"19.3" } ] } } ] } },{ "OutcomeClassTitle":"Week 72 (EOF)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.3", "OutcomeMeasurementLowerLimit":"4.1", "OutcomeMeasurementUpperLimit":"17.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.1", "OutcomeMeasurementLowerLimit":"6.6", "OutcomeMeasurementUpperLimit":"25.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion", "OutcomeMeasureDescription":"A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.", "OutcomeMeasurePopulationDescription":"The ITT population included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 48 and Week 72", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "OutcomeGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "OutcomeGroupDescription":"Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"86" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"64" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 48 (EOT)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.1", "OutcomeMeasurementLowerLimit":"8.3", "OutcomeMeasurementUpperLimit":"24.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"23.4", "OutcomeMeasurementLowerLimit":"13.8", "OutcomeMeasurementUpperLimit":"35.7" } ] } } ] } },{ "OutcomeClassTitle":"Week 72 (EOF)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.9", "OutcomeMeasurementLowerLimit":"12.9", "OutcomeMeasurementUpperLimit":"31.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"21.9", "OutcomeMeasurementLowerLimit":"12.5", "OutcomeMeasurementUpperLimit":"34.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72", "OutcomeMeasureDescription":"A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.", "OutcomeMeasurePopulationDescription":"The ITT population included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 48 and Week 72", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "OutcomeGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "OutcomeGroupDescription":"Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"86" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"64" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 48 (EOT)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.2", "OutcomeMeasurementLowerLimit":"0.03", "OutcomeMeasurementUpperLimit":"6.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.6", "OutcomeMeasurementLowerLimit":"0.04", "OutcomeMeasurementUpperLimit":"8.4" } ] } } ] } },{ "OutcomeClassTitle":"Week 72 (EOF)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.2", "OutcomeMeasurementLowerLimit":"0.03", "OutcomeMeasurementUpperLimit":"6.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.6", "OutcomeMeasurementLowerLimit":"0.04", "OutcomeMeasurementUpperLimit":"8.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72", "OutcomeMeasureDescription":"A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.", "OutcomeMeasurePopulationDescription":"The ITT population included all participants who received at least one dose of study drug.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Week 48 and Week 72", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "OutcomeGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "OutcomeGroupDescription":"Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"86" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"64" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 48 (EOT)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.2", "OutcomeMeasurementLowerLimit":"0.03", "OutcomeMeasurementUpperLimit":"6.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.0", "OutcomeMeasurementUpperLimit":"0.0" } ] } } ] } },{ "OutcomeClassTitle":"Week 72 (EOF)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.2", "OutcomeMeasurementLowerLimit":"0.03", "OutcomeMeasurementUpperLimit":"6.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.6", "OutcomeMeasurementLowerLimit":"0.04", "OutcomeMeasurementUpperLimit":"8.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Any Adverse Events and Any Serious Adverse Events", "OutcomeMeasureDescription":"An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.", "OutcomeMeasurePopulationDescription":"Safety population included participants who received at least one dose of study medication and who had at least one post-baseline safety assessment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"Up to Week 72", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "OutcomeGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "OutcomeGroupDescription":"Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"86" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"64" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Any AEs", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"75" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"54" } ] } } ] } },{ "OutcomeClassTitle":"Any SAEs", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Up to Week 72", "EventsDescription":"An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An AE was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"PEG-IFN Alfa-2a (Treatment naïve)", "EventGroupDescription":"Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.", "EventGroupSeriousNumAffected":"4", "EventGroupSeriousNumAtRisk":"86", "EventGroupOtherNumAffected":"69", "EventGroupOtherNumAtRisk":"86" },{ "EventGroupId":"EG001", "EventGroupTitle":"PEG-IFN Alfa-2a (YMDD Mutant)", "EventGroupDescription":"Group B included tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants who received PEGASYS 180mcg subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up.", "EventGroupSeriousNumAffected":"5", "EventGroupSeriousNumAtRisk":"64", "EventGroupOtherNumAffected":"52", "EventGroupOtherNumAtRisk":"64" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Lymphadenopathy", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 11.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"86" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"64" } ] } },{ "SeriousEventTerm":"Abdominal pain upper", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 11.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"86" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"64" } ] } },{ "SeriousEventTerm":"Appendicitis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 11.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"86" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"64" } ] } },{ "SeriousEventTerm":"Exomphalos", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 11.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"86" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"64" } ] } },{ "SeriousEventTerm":"Haemorrhoids", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 11.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"86" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"64" } ] } },{ "SeriousEventTerm":"Pyrexia", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 11.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"86" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"64" } ] } },{ "SeriousEventTerm":"Cholecystitis acute", "SeriousEventOrganSystem":"Hepatobiliary disorders", "SeriousEventSourceVocabulary":"MedDRA 11.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"86" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"64" } ] } },{ "SeriousEventTerm":"Wrist fracture", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 11.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"86" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"64" } ] } },{ "SeriousEventTerm":"Liver function test abnormal", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 11.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"86" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"64" } ] } },{ "SeriousEventTerm":"Bronchopneumonia", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 11.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"86" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"64" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Neutropenia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"21", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"18", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Abdominal pain upper", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Diarrhoea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Dyspepsia", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"10", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Asthenia", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Fatigue", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"16", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"17", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Influenza like illness", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"11", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"12", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Pain", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"13", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Pyrexia", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Liver function test abnormal", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"10", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Weight decreased", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Anorexia", "OtherEventOrganSystem":"Metabolism and nutrition disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Myalgia", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"9", "OtherEventStatsNumAtRisk":"86" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"64" } ] } },{ "OtherEventTerm":"Dizziness", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA 11.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { 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