{ "FullStudy":{ "Rank":217548, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519960", "OrgStudyIdInfo":{ "OrgStudyId":"YV25718" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-002732-70", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Hoffmann-La Roche", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B", "OfficialTitle":"A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon Alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children With HBeAg Positive Chronic Hepatitis B" }, "StatusModule":{ "StatusVerifiedDate":"February 2020", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"July 11, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 9, 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 9, 2021", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"December 6, 2011", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"July 8, 2016", "ResultsFirstSubmitQCDate":"July 8, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"August 17, 2016", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 4, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 6, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Hoffmann-La Roche", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment with Pegasys. Children in the untreated control Group B who have not experienced seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of Pegasys treatment. This offer will be available for 1 year following 48 weeks from randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hepatitis B, Chronic" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"165", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"A Pegasys", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: peginterferon alfa-2a [Pegasys]" ] } },{ "ArmGroupLabel":"B Untreated Control", "ArmGroupType":"No Intervention" },{ "ArmGroupLabel":"C Fibrosis non-randomized", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: peginterferon alfa-2a [Pegasys]" ] } },{ "ArmGroupLabel":"Switch", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: peginterferon alfa-2a [Pegasys]" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"peginterferon alfa-2a [Pegasys]", "InterventionDescription":"Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "A Pegasys", "C Fibrosis non-randomized" ] } },{ "InterventionType":"Drug", "InterventionName":"peginterferon alfa-2a [Pegasys]", "InterventionDescription":"Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, after Week 48 for Group B patients who have not experienced HBeAg seroconversion", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Switch" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B", "PrimaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method.", "PrimaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"The percentage of participants with loss of HBsAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Normal ALT at EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Quantitative Serum ALT Level in Groups A and B", "SecondaryOutcomeDescription":"Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Quantitative HBV DNA Level in Groups A and B", "SecondaryOutcomeDescription":"Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Quantitative HBV DNA Level in Groups A and B", "SecondaryOutcomeDescription":"The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.", "SecondaryOutcomeTimeFrame":"Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C", "SecondaryOutcomeDescription":"The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C", "SecondaryOutcomeDescription":"HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C", "SecondaryOutcomeDescription":"The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C", "SecondaryOutcomeDescription":"Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBeAg Seroconversion at EOT in Group C", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Loss of HBeAg at EOT in Group C", "SecondaryOutcomeDescription":"The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBsAg Seroconversion at EOT in Group C", "SecondaryOutcomeDescription":"HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Loss of HBsAg at EOT in Group C", "SecondaryOutcomeDescription":"The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Normal ALT at EOT in Group C", "SecondaryOutcomeDescription":"Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBV DNA Undetectable at EOT in Group C", "SecondaryOutcomeDescription":"HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"Week 48" },{ "SecondaryOutcomeMeasure":"Quantitative Serum ALT Level in Group C", "SecondaryOutcomeDescription":"Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Quantitative HBV DNA Level in Group C", "SecondaryOutcomeDescription":"Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Quantitative HBV DNA Level in Group C", "SecondaryOutcomeDescription":"The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.", "SecondaryOutcomeTimeFrame":"Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C", "SecondaryOutcomeDescription":"Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis.", "SecondaryOutcomeTimeFrame":"Baseline; Week 48; FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category", "SecondaryOutcomeDescription":"AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h*ng/mL).", "SecondaryOutcomeTimeFrame":"Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B", "SecondaryOutcomeDescription":"The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.", "SecondaryOutcomeTimeFrame":"Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B", "SecondaryOutcomeDescription":"The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.", "SecondaryOutcomeTimeFrame":"Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With >15% Drop in Height Percentile for Age in Group C", "SecondaryOutcomeDescription":"The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.", "SecondaryOutcomeTimeFrame":"Weeks 12, 24, 48; FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With >15% Drop in Weight Percentile for Age in Group C", "SecondaryOutcomeDescription":"The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.", "SecondaryOutcomeTimeFrame":"Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Height for Age Z-Score in Groups A and B", "SecondaryOutcomeDescription":"The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Weight for Age Z-Score in Groups A and B", "SecondaryOutcomeDescription":"The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Height for Age Z-Score in Group C", "SecondaryOutcomeDescription":"The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Weight for Age Z-Score in Group C", "SecondaryOutcomeDescription":"The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C", "SecondaryOutcomeDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "SecondaryOutcomeTimeFrame":"FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Quantitative Serum ALT Level in Groups A and B", "SecondaryOutcomeDescription":"The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).", "SecondaryOutcomeTimeFrame":"Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Quantitative HBeAg Level in Groups A and B", "SecondaryOutcomeDescription":"Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL).", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Quantitative HBeAg Level in Groups A and B", "SecondaryOutcomeDescription":"The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.", "SecondaryOutcomeTimeFrame":"Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Quantitative HBsAg Level in Groups A and B", "SecondaryOutcomeDescription":"Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Quantitative HBsAg Level in Groups A and B", "SecondaryOutcomeDescription":"The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.", "SecondaryOutcomeTimeFrame":"Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Quantitative Serum ALT Level in Group C", "SecondaryOutcomeDescription":"The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).", "SecondaryOutcomeTimeFrame":"Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Quantitative HBeAg Level in Group C", "SecondaryOutcomeDescription":"Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL.", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Quantitative HBeAg Level in Group C", "SecondaryOutcomeDescription":"The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.", "SecondaryOutcomeTimeFrame":"Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Quantitative HBsAg Level in Group C", "SecondaryOutcomeDescription":"Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.", "SecondaryOutcomeTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Quantitative HBsAg Level in Group C", "SecondaryOutcomeDescription":"The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.", "SecondaryOutcomeTimeFrame":"Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale or female patients, 3 years to <18 years of age at baseline\nPositive HBsAg for more than 6 months\nPositive HBeAg and detectable HBV DNA at screening\nNegative anti-HBs and anti-HBe at screening\nA liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous therapy for hepatitis B) to confirm the presence of advanced fibrosis or exclude cirrhosis\nCompensated liver disease (Child-Pugh Class A)\nElevated serum alanine transferase (ALT)\nNormal thyroid gland function at screening\n\nExclusion Criteria:\n\nSubjects with cirrhosis\nSubjects must not have received investigational drugs or licensed treatments with anti-HBV activity within 6 months of baseline. Subjects who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded\nKnown hypersensitivity to peginterferon\nPositive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV infection\nHistory or evidence of medical condition associated with chronic liver disease other than chronic hepatitis B\nHistory or evidence of bleeding from esophageal varices\nDecompensated liver disease (e.g. ascites, Child-Pugh Class B or C)\nHistory of immunologically mediated disease\nPregnant or lactating females", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"3 Years", "MaximumAge":"17 Years", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Clinical Trials", "OverallOfficialAffiliation":"Hoffmann-La Roche", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Univ of California SF, Benioff Children's Hospital; Pediatrics, Gastro, Hepatology & Nutrition", "LocationCity":"San Francisco", "LocationState":"California", "LocationZip":"94143", "LocationCountry":"United States" },{ "LocationFacility":"Johns Hopkins Hospital - Pediatric Gastroenterology", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21287-5554", "LocationCountry":"United States" },{ "LocationFacility":"Children's Hospital Boston-Harvard Medical School; Division of Gastoenterology", "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationZip":"02115", "LocationCountry":"United States" },{ "LocationFacility":"St. Louis University - Cardinal Glennon Children's Medical Center", "LocationCity":"Saint Louis", "LocationState":"Missouri", "LocationZip":"63104", "LocationCountry":"United States" },{ "LocationFacility":"Texas Children's Hospital", "LocationCity":"Houston", "LocationState":"Texas", "LocationZip":"77030", "LocationCountry":"United States" },{ "LocationFacility":"Seattle Children's Hospital", "LocationCity":"Seattle", "LocationState":"Washington", "LocationZip":"98105", "LocationCountry":"United States" },{ "LocationFacility":"Womens and Childrens Hospital; Department of Gastroenterology", "LocationCity":"North Adelaide", "LocationState":"South Australia", "LocationZip":"5006", "LocationCountry":"Australia" },{ "LocationFacility":"Royal Children's Hospital; Department of Gastroenterology", "LocationCity":"Melbourne", "LocationState":"Victoria", "LocationZip":"3053", "LocationCountry":"Australia" },{ "LocationFacility":"Cliniques Universitaires St-Luc", "LocationCity":"Bruxelles", "LocationZip":"1200", "LocationCountry":"Belgium" },{ "LocationFacility":"UZ Gent", "LocationCity":"Gent", "LocationZip":"9000", "LocationCountry":"Belgium" },{ "LocationFacility":"Specialized Hospital for Active Treatment of Pediatrics Diseases; Clinic of Gastroenterology", "LocationCity":"Sofia", "LocationZip":"1612", "LocationCountry":"Bulgaria" },{ "LocationFacility":"University Hospital \"St. Marine\"; Dept. of Pediatrics", "LocationCity":"Varna", "LocationZip":"9000", "LocationCountry":"Bulgaria" },{ "LocationFacility":"Beijing 302 Hospital; No. 2 Infectious Disease Section", "LocationCity":"Beijing", "LocationZip":"100039", "LocationCountry":"China" },{ "LocationFacility":"Beijing You An Hospital; Digestive Dept", "LocationCity":"Beijing", "LocationZip":"100069", "LocationCountry":"China" },{ "LocationFacility":"the First Hospital of Jilin University", "LocationCity":"Changchun", "LocationZip":"130021", "LocationCountry":"China" },{ "LocationFacility":"Southwest Hospital , Third Military Medical University", "LocationCity":"Chongqing", "LocationZip":"400038", "LocationCountry":"China" },{ "LocationFacility":"The Eighth People's Hospital of Guangzhou", "LocationCity":"Guangzhou", "LocationZip":"510060", "LocationCountry":"China" },{ "LocationFacility":"The Third Affiliated Hospital of Sun Yat-Sen University", "LocationCity":"Guangzhou", "LocationZip":"510630", "LocationCountry":"China" },{ "LocationFacility":"The First Affilliated Hospital of Kunming Medical College", "LocationCity":"Kunming", "LocationZip":"650032", "LocationCountry":"China" },{ "LocationFacility":"Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine", "LocationCity":"Urumqi (乌鲁木齐)", "LocationZip":"830000", "LocationCountry":"China" },{ "LocationFacility":"Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech", "LocationCity":"Wuhan", "LocationZip":"430030", "LocationCountry":"China" },{ "LocationFacility":"First Affiliated Hospital of Medical College of Xi'an Jiaotong University", "LocationCity":"Xi'an", "LocationZip":"710061", "LocationCountry":"China" },{ "LocationFacility":"HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke", "LocationCity":"Wuppertal", "LocationZip":"42283", "LocationCountry":"Germany" },{ "LocationFacility":"Rambam Medical Center", "LocationCity":"Haifa", "LocationZip":"3109601", "LocationCountry":"Israel" },{ "LocationFacility":"Hadassah University Hospital - Ein Kerem", "LocationCity":"Jerusalem", "LocationZip":"9112001", "LocationCountry":"Israel" },{ "LocationFacility":"Western Galilee Hospital - Nahariya", "LocationCity":"Nahariya", "LocationZip":"22100", "LocationCountry":"Israel" },{ "LocationFacility":"Uni Degli Studi Di Bologna - Policlinica S. Orsola; Inst. Di Malattie Infettive", "LocationCity":"Bologna", "LocationState":"Emilia-Romagna", "LocationZip":"40138", "LocationCountry":"Italy" },{ "LocationFacility":"Wojewodzki Szpital Obserwacyjno-Zakazny; Oddział Pediatrii, Chorób Infekcyjnych i Hepatologii", "LocationCity":"Bydgoszcz", "LocationZip":"85-030", "LocationCountry":"Poland" },{ "LocationFacility":"Krakowski Szpital Specjalistyczny im Jana Pawła II; Oddział Chorób Infekcyjnych Dzieci", "LocationCity":"Krakow", "LocationZip":"31-202", "LocationCountry":"Poland" },{ "LocationFacility":"Wojewodzki Specjalistyczny Szpital im. Dr W.Bieganskiego; Oddział Obserwacyjno-Zakażny dla Dzieci", "LocationCity":"Łodz", "LocationZip":"91-347", "LocationCountry":"Poland" },{ "LocationFacility":"SFI Sceintific Research institute of nutrition of RAMS", "LocationCity":"Moscow", "LocationZip":"115446", "LocationCountry":"Russian Federation" },{ "LocationFacility":"SI Sceintific children health center RAMS", "LocationCity":"Moscow", "LocationZip":"119991", "LocationCountry":"Russian Federation" },{ "LocationFacility":"FSI Scientific research Institute of children's infections", "LocationCity":"Saint Petersburg", "LocationZip":"197022", "LocationCountry":"Russian Federation" },{ "LocationFacility":"MC Gepatolog", "LocationCity":"Samara", "LocationZip":"443100", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Kyiv Children's Clinical Infectious Diseases Hospital", "LocationCity":"Kyiv", "LocationZip":"01119", "LocationCountry":"Ukraine" },{ "LocationFacility":"SI Institute of the pediatrics, obstetrics and gynecology", "LocationCity":"Kyiv", "LocationZip":"04050", "LocationCountry":"Ukraine" },{ "LocationFacility":"Birmingham Children'S Hopsital; Liver Unit", "LocationCity":"Birmingham", "LocationZip":"B4 6NH", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Kings College Hospital NHS Foundation Trust", "LocationCity":"London", "LocationZip":"SE5 9RS", "LocationCountry":"United Kingdom" },{ "LocationFacility":"Imperial College Healthcare Trust", "LocationCity":"London", "LocationZip":"W2 1PG", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"29689122", "ReferenceType":"derived", "ReferenceCitation":"Wirth S, Zhang H, Hardikar W, Schwarz KB, Sokal E, Yang W, Fan H, Morozov V, Mao Q, Deng H, Huang Y, Yang L, Frey N, Nasmyth-Miller C, Pavlovic V, Wat C. Efficacy and Safety of Peginterferon Alfa-2a (40KD) in Children With Chronic Hepatitis B: The PEG-B-ACTIVE Study. Hepatology. 2018 Nov;68(5):1681-1694. doi: 10.1002/hep.30050. Epub 2018 Oct 8." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"A total of 211 individuals were screened for entry into the study. Of these, there were 161 participants enrolled in the study and included in the main analyses.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "FlowGroupDescription":"Participants without advanced fibrosis were randomized and received peginterferon alfa-2a (PEG-IFN) monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on body surface area (BSA) and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 square meters (m^2), 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; greater than (>) 1.51 m^2, 180 mcg." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "FlowGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "FlowGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"101" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"50" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"Completed Week 48", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"99" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"47" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"Completed Follow-Up (FU) Week 12", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"101" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"26" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"Completed FU Week 24", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"101" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"15" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"101" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"50" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"10" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Ongoing in Follow-Up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"101" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"11" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"10" } ] } },{ "FlowDropWithdrawType":"Ongoing/Switched to PEG-IFN", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"33" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Full Analysis Population: All participants who were randomized into the study and who were included in any of the study analyses.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "BaselineGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "BaselineGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "BaselineGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"101" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"50" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"10" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"161" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10.41", "BaselineMeasurementSpread":"4.57" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"11.20", "BaselineMeasurementSpread":"5.01" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6.70", "BaselineMeasurementSpread":"3.27" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"10.42", "BaselineMeasurementSpread":"4.73" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"37" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"57" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"64" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"32" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"104" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"25.7", "OutcomeMeasurementLowerLimit":"17.56", "OutcomeMeasurementUpperLimit":"35.40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.0", "OutcomeMeasurementLowerLimit":"1.25", "OutcomeMeasurementUpperLimit":"16.55" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Analysis stratified by hepatitis B virus (HBV) genotype A versus non-A genotypes and alanine aminotransferase (ALT) less than (<) 5 times (×) upper limit of normal (ULN) versus greater than or equal (≥) 5 × ULN at Baseline.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0043", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"5.43", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.54", "OutcomeAnalysisCIUpperLimit":"19.20", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.3732", "OutcomeAnalysisStatisticalMethod":"Breslow-Day" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B", "OutcomeMeasureDescription":"The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"25.7", "OutcomeMeasurementLowerLimit":"17.56", "OutcomeMeasurementUpperLimit":"35.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.0", "OutcomeMeasurementLowerLimit":"1.25", "OutcomeMeasurementUpperLimit":"16.55" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0038", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"5.43", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.52", "OutcomeAnalysisCIUpperLimit":"29.32", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.9", "OutcomeMeasurementLowerLimit":"3.48", "OutcomeMeasurementUpperLimit":"15.01" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.00", "OutcomeMeasurementUpperLimit":"7.11" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0528", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT/POP in Groups A and B", "OutcomeMeasureDescription":"The percentage of participants with loss of HBsAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.9", "OutcomeMeasurementLowerLimit":"4.16", "OutcomeMeasurementUpperLimit":"16.24" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.00", "OutcomeMeasurementUpperLimit":"7.11" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0300", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B", "OutcomeMeasureDescription":"Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"51.5", "OutcomeMeasurementLowerLimit":"41.33", "OutcomeMeasurementUpperLimit":"61.55" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12.0", "OutcomeMeasurementLowerLimit":"4.53", "OutcomeMeasurementUpperLimit":"24.31" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"7.78", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"2.91", "OutcomeAnalysisCIUpperLimit":"24.05", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"33.7", "OutcomeMeasurementLowerLimit":"24.56", "OutcomeMeasurementUpperLimit":"43.75" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.0", "OutcomeMeasurementLowerLimit":"0.49", "OutcomeMeasurementUpperLimit":"13.71" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"12.18", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"2.85", "OutcomeAnalysisCIUpperLimit":"108.3", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"28.7", "OutcomeMeasurementLowerLimit":"20.15", "OutcomeMeasurementUpperLimit":"38.57" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementLowerLimit":"0.05", "OutcomeMeasurementUpperLimit":"10.65" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"19.74", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"3.02", "OutcomeAnalysisCIUpperLimit":"822.2", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16.8", "OutcomeMeasurementLowerLimit":"10.12", "OutcomeMeasurementUpperLimit":"25.58" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementLowerLimit":"0.05", "OutcomeMeasurementUpperLimit":"10.65" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0069", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"9.92", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.45", "OutcomeAnalysisCIUpperLimit":"422.7", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22.8", "OutcomeMeasurementLowerLimit":"15.02", "OutcomeMeasurementUpperLimit":"32.18" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.0", "OutcomeMeasurementLowerLimit":"0.49", "OutcomeMeasurementUpperLimit":"13.71" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0025", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"7.08", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.61", "OutcomeAnalysisCIUpperLimit":"64.02", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"19.8", "OutcomeMeasurementLowerLimit":"12.54", "OutcomeMeasurementUpperLimit":"28.91" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementLowerLimit":"0.05", "OutcomeMeasurementUpperLimit":"10.65" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0021", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"12.10", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.80", "OutcomeAnalysisCIUpperLimit":"511.5", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.9", "OutcomeMeasurementLowerLimit":"3.48", "OutcomeMeasurementUpperLimit":"15.01" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.0", "OutcomeMeasurementLowerLimit":"1.25", "OutcomeMeasurementUpperLimit":"16.55" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"1.0000", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"1.35", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.30", "OutcomeAnalysisCIUpperLimit":"8.23", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B", "OutcomeMeasureDescription":"The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.9", "OutcomeMeasurementLowerLimit":"4.16", "OutcomeMeasurementUpperLimit":"16.24" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.0", "OutcomeMeasurementLowerLimit":"1.25", "OutcomeMeasurementUpperLimit":"16.55" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.7515", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"1.53", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.36", "OutcomeAnalysisCIUpperLimit":"9.19", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.9", "OutcomeMeasurementLowerLimit":"2.83", "OutcomeMeasurementUpperLimit":"13.76" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.00", "OutcomeMeasurementUpperLimit":"7.11" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0960", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B", "OutcomeMeasureDescription":"The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.9", "OutcomeMeasurementLowerLimit":"5.56", "OutcomeMeasurementUpperLimit":"18.65" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.00", "OutcomeMeasurementUpperLimit":"7.11" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0163", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Normal ALT at EOT/POP in Groups A and B", "OutcomeMeasureDescription":"Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"18.8", "OutcomeMeasurementLowerLimit":"11.72", "OutcomeMeasurementUpperLimit":"27.81" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"22.0", "OutcomeMeasurementLowerLimit":"11.53", "OutcomeMeasurementUpperLimit":"35.96" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.6684", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"0.82", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.33", "OutcomeAnalysisCIUpperLimit":"2.11", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"36.6", "OutcomeMeasurementLowerLimit":"27.27", "OutcomeMeasurementUpperLimit":"46.81" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12.0", "OutcomeMeasurementLowerLimit":"4.53", "OutcomeMeasurementUpperLimit":"24.31" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0019", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"4.24", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"1.58", "OutcomeAnalysisCIUpperLimit":"13.23", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.7", "OutcomeMeasurementLowerLimit":"21.90", "OutcomeMeasurementUpperLimit":"40.66" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementLowerLimit":"0.05", "OutcomeMeasurementUpperLimit":"10.65" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"<0.0001", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"21.70", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"3.33", "OutcomeAnalysisCIUpperLimit":"902.1", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"18.8", "OutcomeMeasurementLowerLimit":"11.72", "OutcomeMeasurementUpperLimit":"27.81" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.00", "OutcomeMeasurementUpperLimit":"7.11" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0004", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.9", "OutcomeMeasurementLowerLimit":"2.83", "OutcomeMeasurementUpperLimit":"13.76" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.0", "OutcomeMeasurementLowerLimit":"1.25", "OutcomeMeasurementUpperLimit":"16.55" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"1.0000", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"1.17", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.25", "OutcomeAnalysisCIUpperLimit":"7.30", "OutcomeAnalysisEstimateComment":"The OR was calculated using Group B as reference." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"ITT Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.9", "OutcomeMeasurementLowerLimit":"2.83", "OutcomeMeasurementUpperLimit":"13.76" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.00", "OutcomeMeasurementUpperLimit":"7.11" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other (legacy)", "OutcomeAnalysisPValue":"0.0960", "OutcomeAnalysisStatisticalMethod":"Fisher's Exact" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Quantitative Serum ALT Level in Groups A and B", "OutcomeMeasureDescription":"Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).", "OutcomeMeasurePopulationDescription":"ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"factor of ULN", "OutcomeMeasureTimeFrame":"Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=101,50)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.779", "OutcomeMeasurementSpread":"2.483" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.878", "OutcomeMeasurementSpread":"1.997" } ] } } ] } },{ "OutcomeClassTitle":"Week 1 (n=98,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.427", "OutcomeMeasurementSpread":"2.687" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 2 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.846", "OutcomeMeasurementSpread":"1.885" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 4 (n=101,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.343", "OutcomeMeasurementSpread":"2.455" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 8 (n=100,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.262", "OutcomeMeasurementSpread":"2.797" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=97,49)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.189", "OutcomeMeasurementSpread":"3.060" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.492", "OutcomeMeasurementSpread":"6.532" } ] } } ] } },{ "OutcomeClassTitle":"Week 18 (n=98,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.036", "OutcomeMeasurementSpread":"2.389" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=99,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.753", "OutcomeMeasurementSpread":"2.725" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.401", "OutcomeMeasurementSpread":"2.638" } ] } } ] } },{ "OutcomeClassTitle":"Week 30 (n=98,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.587", "OutcomeMeasurementSpread":"2.128" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=99,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.450", "OutcomeMeasurementSpread":"1.856" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.341", "OutcomeMeasurementSpread":"2.204" } ] } } ] } },{ "OutcomeClassTitle":"Week 42 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.316", "OutcomeMeasurementSpread":"1.429" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=99,46)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.122", "OutcomeMeasurementSpread":"1.389" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.954", "OutcomeMeasurementSpread":"1.371" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.303", "OutcomeMeasurementSpread":"1.740" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=100,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.064", "OutcomeMeasurementSpread":"2.027" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=101,15)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.477", "OutcomeMeasurementSpread":"1.625" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.700", "OutcomeMeasurementSpread":"1.385" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Quantitative HBV DNA Level in Groups A and B", "OutcomeMeasureDescription":"Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.", "OutcomeMeasurePopulationDescription":"ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 IU/mL", "OutcomeMeasureTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=101,50)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.094", "OutcomeMeasurementSpread":"0.986" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.056", "OutcomeMeasurementSpread":"0.987" } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=98,49)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.490", "OutcomeMeasurementSpread":"2.009" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.909", "OutcomeMeasurementSpread":"1.267" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=99,46)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.966", "OutcomeMeasurementSpread":"2.398" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.857", "OutcomeMeasurementSpread":"1.327" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=99,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.575", "OutcomeMeasurementSpread":"2.513" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.685", "OutcomeMeasurementSpread":"1.608" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=99,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.224", "OutcomeMeasurementSpread":"2.701" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.551", "OutcomeMeasurementSpread":"1.761" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=97,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.739", "OutcomeMeasurementSpread":"2.935" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=98,21)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.914", "OutcomeMeasurementSpread":"3.065" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.214", "OutcomeMeasurementSpread":"2.460" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=98,13)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.707", "OutcomeMeasurementSpread":"3.113" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.200", "OutcomeMeasurementSpread":"2.506" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Quantitative HBV DNA Level in Groups A and B", "OutcomeMeasureDescription":"The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.", "OutcomeMeasurePopulationDescription":"ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 IU/mL", "OutcomeMeasureTimeFrame":"Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12 (n=98,49)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.588", "OutcomeMeasurementSpread":"1.625" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.156", "OutcomeMeasurementSpread":"1.093" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=99,46)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.112", "OutcomeMeasurementSpread":"1.996" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.168", "OutcomeMeasurementSpread":"1.214" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=99,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.525", "OutcomeMeasurementSpread":"2.148" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.359", "OutcomeMeasurementSpread":"1.411" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=99,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.877", "OutcomeMeasurementSpread":"2.374" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.493", "OutcomeMeasurementSpread":"1.518" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=97,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.340", "OutcomeMeasurementSpread":"2.582" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=98,21)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.164", "OutcomeMeasurementSpread":"2.737" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.860", "OutcomeMeasurementSpread":"2.163" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=98,13)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.381", "OutcomeMeasurementSpread":"2.778" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.587", "OutcomeMeasurementSpread":"2.259" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C", "OutcomeMeasureDescription":"The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.0", "OutcomeMeasurementLowerLimit":"6.67", "OutcomeMeasurementUpperLimit":"65.25" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C", "OutcomeMeasureDescription":"HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.00", "OutcomeMeasurementUpperLimit":"30.85" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C", "OutcomeMeasureDescription":"The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.00", "OutcomeMeasurementUpperLimit":"30.85" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C", "OutcomeMeasureDescription":"Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"70.0", "OutcomeMeasurementLowerLimit":"34.75", "OutcomeMeasurementUpperLimit":"93.33" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"70.0", "OutcomeMeasurementLowerLimit":"34.75", "OutcomeMeasurementUpperLimit":"93.33" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"70.0", "OutcomeMeasurementLowerLimit":"34.75", "OutcomeMeasurementUpperLimit":"93.33" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.0", "OutcomeMeasurementLowerLimit":"6.67", "OutcomeMeasurementUpperLimit":"65.25" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.0", "OutcomeMeasurementLowerLimit":"6.67", "OutcomeMeasurementUpperLimit":"65.25" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.0", "OutcomeMeasurementLowerLimit":"6.67", "OutcomeMeasurementUpperLimit":"65.25" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBeAg Seroconversion at EOT in Group C", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.0", "OutcomeMeasurementLowerLimit":"2.52", "OutcomeMeasurementUpperLimit":"55.61" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Loss of HBeAg at EOT in Group C", "OutcomeMeasureDescription":"The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.0", "OutcomeMeasurementLowerLimit":"2.52", "OutcomeMeasurementUpperLimit":"55.61" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBsAg Seroconversion at EOT in Group C", "OutcomeMeasureDescription":"HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.00", "OutcomeMeasurementUpperLimit":"30.85" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Loss of HBsAg at EOT in Group C", "OutcomeMeasureDescription":"The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0", "OutcomeMeasurementLowerLimit":"0.00", "OutcomeMeasurementUpperLimit":"30.85" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Normal ALT at EOT in Group C", "OutcomeMeasureDescription":"Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"40.0", "OutcomeMeasurementLowerLimit":"12.16", "OutcomeMeasurementUpperLimit":"73.76" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"40.0", "OutcomeMeasurementLowerLimit":"12.16", "OutcomeMeasurementUpperLimit":"73.76" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.0", "OutcomeMeasurementLowerLimit":"6.67", "OutcomeMeasurementUpperLimit":"65.25" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBV DNA Undetectable at EOT in Group C", "OutcomeMeasureDescription":"HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.0", "OutcomeMeasurementLowerLimit":"2.52", "OutcomeMeasurementUpperLimit":"55.61" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.0", "OutcomeMeasurementLowerLimit":"2.52", "OutcomeMeasurementUpperLimit":"55.61" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 48", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.0", "OutcomeMeasurementLowerLimit":"2.52", "OutcomeMeasurementUpperLimit":"55.61" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Quantitative Serum ALT Level in Group C", "OutcomeMeasureDescription":"Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).", "OutcomeMeasurePopulationDescription":"Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"factor of ULN", "OutcomeMeasureTimeFrame":"Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.804", "OutcomeMeasurementSpread":"1.118" } ] } } ] } },{ "OutcomeClassTitle":"Week 1 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.117", "OutcomeMeasurementSpread":"1.322" } ] } } ] } },{ "OutcomeClassTitle":"Week 2 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.896", "OutcomeMeasurementSpread":"1.304" } ] } } ] } },{ "OutcomeClassTitle":"Week 4 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.444", "OutcomeMeasurementSpread":"1.727" } ] } } ] } },{ "OutcomeClassTitle":"Week 8 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.703", "OutcomeMeasurementSpread":"2.035" } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.793", "OutcomeMeasurementSpread":"1.288" } ] } } ] } },{ "OutcomeClassTitle":"Week 18 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.215", "OutcomeMeasurementSpread":"1.032" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.887", "OutcomeMeasurementSpread":"1.095" } ] } } ] } },{ "OutcomeClassTitle":"Week 30 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.220", "OutcomeMeasurementSpread":"1.553" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.172", "OutcomeMeasurementSpread":"1.090" } ] } } ] } },{ "OutcomeClassTitle":"Week 42 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.593", "OutcomeMeasurementSpread":"0.516" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.645", "OutcomeMeasurementSpread":"1.242" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.136", "OutcomeMeasurementSpread":"0.506" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.521", "OutcomeMeasurementSpread":"0.755" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.549", "OutcomeMeasurementSpread":"1.595" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Quantitative HBV DNA Level in Group C", "OutcomeMeasureDescription":"Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.", "OutcomeMeasurePopulationDescription":"Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 IU/mL", "OutcomeMeasureTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.866", "OutcomeMeasurementSpread":"0.977" } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.782", "OutcomeMeasurementSpread":"1.771" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.599", "OutcomeMeasurementSpread":"2.386" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.200", "OutcomeMeasurementSpread":"2.451" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.319", "OutcomeMeasurementSpread":"2.747" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.604", "OutcomeMeasurementSpread":"2.442" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.252", "OutcomeMeasurementSpread":"2.596" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.694", "OutcomeMeasurementSpread":"3.127" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Quantitative HBV DNA Level in Group C", "OutcomeMeasureDescription":"The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.", "OutcomeMeasurePopulationDescription":"Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 IU/mL", "OutcomeMeasureTimeFrame":"Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.084", "OutcomeMeasurementSpread":"1.100" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.267", "OutcomeMeasurementSpread":"1.595" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.529", "OutcomeMeasurementSpread":"1.879" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-2.546", "OutcomeMeasurementSpread":"2.140" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-3.262", "OutcomeMeasurementSpread":"2.102" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-3.613", "OutcomeMeasurementSpread":"2.519" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-4.150", "OutcomeMeasurementSpread":"2.904" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C", "OutcomeMeasureDescription":"Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis.", "OutcomeMeasurePopulationDescription":"Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. The \"Number of Participants Analyzed\" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"kPa", "OutcomeMeasureTimeFrame":"Baseline; Week 48; FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"44" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"25" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 48 (n=40,21,6)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.490", "OutcomeMeasurementSpread":"2.151" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.376", "OutcomeMeasurementSpread":"2.719" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-1.517", "OutcomeMeasurementSpread":"1.685" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=38,5,6)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.026", "OutcomeMeasurementSpread":"2.269" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.720", "OutcomeMeasurementSpread":"2.633" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-1.700", "OutcomeMeasurementSpread":"1.033" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category", "OutcomeMeasureDescription":"AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h*ng/mL).", "OutcomeMeasurePopulationDescription":"PK Substudy Population: All participants who consented to participate in the PK substudy. The \"Number of Participants Analyzed\" reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"h*ng/mL", "OutcomeMeasureTimeFrame":"Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"All Groups Combined", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized to receive PEG-IFN monotherapy or were evaluated as untreated control for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for the same duration. For those who received PEG-IFN treatment, each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"30" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"0.54-0.74 m^2 (n=5)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3320", "OutcomeMeasurementLowerLimit":"633", "OutcomeMeasurementUpperLimit":"5064" } ] } } ] } },{ "OutcomeClassTitle":"0.75-1.08 m^2 (n=11)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4037", "OutcomeMeasurementLowerLimit":"1897", "OutcomeMeasurementUpperLimit":"6916" } ] } } ] } },{ "OutcomeClassTitle":"1.09-1.51 m^2 (n=7)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2765", "OutcomeMeasurementLowerLimit":"1750", "OutcomeMeasurementUpperLimit":"4392" } ] } } ] } },{ "OutcomeClassTitle":">1.51 m^2 (n=7)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3448", "OutcomeMeasurementLowerLimit":"1914", "OutcomeMeasurementUpperLimit":"5000" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B", "OutcomeMeasureDescription":"The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.", "OutcomeMeasurePopulationDescription":"Safety Population. The \"Number of Participants Analyzed\" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"48" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12 (n=99,48)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=100,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.5" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=99,48)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.2" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=98,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.1" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=101,24)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.2" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=100,15)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B", "OutcomeMeasureDescription":"The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.", "OutcomeMeasurePopulationDescription":"Safety Population. The \"Number of Participants Analyzed\" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"48" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 4 (n=101,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 8 (n=101,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=99,48)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.1" } ] } } ] } },{ "OutcomeClassTitle":"Week 18 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=100,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.5" } ] } } ] } },{ "OutcomeClassTitle":"Week 30 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=97,48)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.3" } ] } } ] } },{ "OutcomeClassTitle":"Week 42 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=96,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.5" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=101,24)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"20.8" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=100,15)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"20.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With >15% Drop in Height Percentile for Age in Group C", "OutcomeMeasureDescription":"The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Weeks 12, 24, 48; FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.0" } ] } } ] } },{ "OutcomeClassTitle":"Week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.0" } ] } } ] } },{ "OutcomeClassTitle":"Week 48", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.0" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With >15% Drop in Weight Percentile for Age in Group C", "OutcomeMeasureDescription":"The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 30", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.0" } ] } } ] } },{ "OutcomeClassTitle":"Week 36", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.0" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.0" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.0" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Height for Age Z-Score in Groups A and B", "OutcomeMeasureDescription":"The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.", "OutcomeMeasurePopulationDescription":"Safety Population. The \"Number of Participants Analyzed\" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"standard deviations", "OutcomeMeasureTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"49" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=101,49)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.271", "OutcomeMeasurementSpread":"1.149" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.062", "OutcomeMeasurementSpread":"1.170" } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=99,48)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.011", "OutcomeMeasurementSpread":"0.258" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.006", "OutcomeMeasurementSpread":"0.185" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=100,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.040", "OutcomeMeasurementSpread":"0.293" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.071", "OutcomeMeasurementSpread":"0.264" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=99,48)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.056", "OutcomeMeasurementSpread":"0.337" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.025", "OutcomeMeasurementSpread":"0.328" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=98,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.099", "OutcomeMeasurementSpread":"0.365" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.013", "OutcomeMeasurementSpread":"0.284" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=101,24)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.112", "OutcomeMeasurementSpread":"0.404" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.037", "OutcomeMeasurementSpread":"0.243" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=100,15)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.117", "OutcomeMeasurementSpread":"0.429" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.079", "OutcomeMeasurementSpread":"0.282" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Weight for Age Z-Score in Groups A and B", "OutcomeMeasureDescription":"The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.", "OutcomeMeasurePopulationDescription":"Safety Population. The \"Number of Participants Analyzed\" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"standard deviations", "OutcomeMeasureTimeFrame":"Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"49" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=101,49)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.106", "OutcomeMeasurementSpread":"1.154" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.047", "OutcomeMeasurementSpread":"1.154" } ] } } ] } },{ "OutcomeClassTitle":"Week 1 (n=100,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.024", "OutcomeMeasurementSpread":"0.089" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 2 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.023", "OutcomeMeasurementSpread":"0.108" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 4 (n=101,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.048", "OutcomeMeasurementSpread":"0.158" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 8 (n=101,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.082", "OutcomeMeasurementSpread":"0.228" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=99,48)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.090", "OutcomeMeasurementSpread":"0.267" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.041", "OutcomeMeasurementSpread":"0.241" } ] } } ] } },{ "OutcomeClassTitle":"Week 18 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.155", "OutcomeMeasurementSpread":"0.309" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=100,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.165", "OutcomeMeasurementSpread":"0.350" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.090", "OutcomeMeasurementSpread":"0.323" } ] } } ] } },{ "OutcomeClassTitle":"Week 30 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.189", "OutcomeMeasurementSpread":"0.372" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=97,48)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.192", "OutcomeMeasurementSpread":"0.395" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.057", "OutcomeMeasurementSpread":"0.338" } ] } } ] } },{ "OutcomeClassTitle":"Week 42 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.240", "OutcomeMeasurementSpread":"0.375" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=96,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.214", "OutcomeMeasurementSpread":"0.371" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.082", "OutcomeMeasurementSpread":"0.343" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.156", "OutcomeMeasurementSpread":"0.346" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=101,24)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.089", "OutcomeMeasurementSpread":"0.384" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.263", "OutcomeMeasurementSpread":"0.333" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=100,15)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.046", "OutcomeMeasurementSpread":"0.452" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.322", "OutcomeMeasurementSpread":"0.325" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Height for Age Z-Score in Group C", "OutcomeMeasureDescription":"The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"standard deviations", "OutcomeMeasureTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.586", "OutcomeMeasurementSpread":"0.947" } ] } } ] } },{ "OutcomeClassTitle":"Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.070", "OutcomeMeasurementSpread":"0.492" } ] } } ] } },{ "OutcomeClassTitle":"Week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.262", "OutcomeMeasurementSpread":"0.420" } ] } } ] } },{ "OutcomeClassTitle":"Week 36", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.300", "OutcomeMeasurementSpread":"0.601" } ] } } ] } },{ "OutcomeClassTitle":"Week 48", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.190", "OutcomeMeasurementSpread":"0.683" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.205", "OutcomeMeasurementSpread":"0.611" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.064", "OutcomeMeasurementSpread":"0.634" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Weight for Age Z-Score in Group C", "OutcomeMeasureDescription":"The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.", "OutcomeMeasurePopulationDescription":"Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"standard deviations", "OutcomeMeasureTimeFrame":"Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.187", "OutcomeMeasurementSpread":"1.141" } ] } } ] } },{ "OutcomeClassTitle":"Week 1 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.044", "OutcomeMeasurementSpread":"0.052" } ] } } ] } },{ "OutcomeClassTitle":"Week 2 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.023", "OutcomeMeasurementSpread":"0.107" } ] } } ] } },{ "OutcomeClassTitle":"Week 4 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.049", "OutcomeMeasurementSpread":"0.243" } ] } } ] } },{ "OutcomeClassTitle":"Week 8 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.041", "OutcomeMeasurementSpread":"0.198" } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.012", "OutcomeMeasurementSpread":"0.288" } ] } } ] } },{ "OutcomeClassTitle":"Week 18 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.018", "OutcomeMeasurementSpread":"0.377" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.089", "OutcomeMeasurementSpread":"0.245" } ] } } ] } },{ "OutcomeClassTitle":"Week 30 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.094", "OutcomeMeasurementSpread":"0.340" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.000", "OutcomeMeasurementSpread":"0.443" } ] } } ] } },{ "OutcomeClassTitle":"Week 42 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.032", "OutcomeMeasurementSpread":"0.344" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.208", "OutcomeMeasurementSpread":"0.374" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.054", "OutcomeMeasurementSpread":"0.350" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.156", "OutcomeMeasurementSpread":"0.290" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.161", "OutcomeMeasurementSpread":"0.309" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C", "OutcomeMeasureDescription":"HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30.0", "OutcomeMeasurementLowerLimit":"6.67", "OutcomeMeasurementUpperLimit":"65.25" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Quantitative Serum ALT Level in Groups A and B", "OutcomeMeasureDescription":"The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).", "OutcomeMeasurePopulationDescription":"ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"factor of ULN", "OutcomeMeasureTimeFrame":"Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 1 (n=98,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.606", "OutcomeMeasurementSpread":"1.565" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 2 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.060", "OutcomeMeasurementSpread":"2.283" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 4 (n=101,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.564", "OutcomeMeasurementSpread":"3.026" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 8 (n=100,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.463", "OutcomeMeasurementSpread":"3.225" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=97,49)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.415", "OutcomeMeasurementSpread":"3.732" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.598", "OutcomeMeasurementSpread":"5.934" } ] } } ] } },{ "OutcomeClassTitle":"Week 18 (n=98,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.288", "OutcomeMeasurementSpread":"3.332" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=99,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.004", "OutcomeMeasurementSpread":"3.496" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.462", "OutcomeMeasurementSpread":"2.311" } ] } } ] } },{ "OutcomeClassTitle":"Week 30 (n=98,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.100", "OutcomeMeasurementSpread":"3.163" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=99,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.302", "OutcomeMeasurementSpread":"2.800" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.510", "OutcomeMeasurementSpread":"1.835" } ] } } ] } },{ "OutcomeClassTitle":"Week 42 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.436", "OutcomeMeasurementSpread":"2.732" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=99,46)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.630", "OutcomeMeasurementSpread":"2.652" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.939", "OutcomeMeasurementSpread":"1.914" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=99,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.474", "OutcomeMeasurementSpread":"2.889" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=100,0)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.736", "OutcomeMeasurementSpread":"2.972" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"The calculation was not performed because no participants provided data for the visit." } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=101,15)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.302", "OutcomeMeasurementSpread":"2.766" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.701", "OutcomeMeasurementSpread":"2.220" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Quantitative HBeAg Level in Groups A and B", "OutcomeMeasureDescription":"Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL).", "OutcomeMeasurePopulationDescription":"ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 PEIU/mL", "OutcomeMeasureTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=92,43)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.736", "OutcomeMeasurementSpread":"0.502" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.568", "OutcomeMeasurementSpread":"0.650" } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=90,45)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.090", "OutcomeMeasurementSpread":"0.879" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.391", "OutcomeMeasurementSpread":"0.878" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=93,41)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.865", "OutcomeMeasurementSpread":"0.956" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.360", "OutcomeMeasurementSpread":"0.896" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=90,41)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.604", "OutcomeMeasurementSpread":"0.991" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.272", "OutcomeMeasurementSpread":"0.985" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=98,46)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.466", "OutcomeMeasurementSpread":"1.053" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.124", "OutcomeMeasurementSpread":"1.091" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=100,14)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.537", "OutcomeMeasurementSpread":"1.334" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.217", "OutcomeMeasurementSpread":"1.395" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Quantitative HBeAg Level in Groups A and B", "OutcomeMeasureDescription":"The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.", "OutcomeMeasurePopulationDescription":"ITT Population. The \"Number of Participants Analyzed\" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 PEIU/mL", "OutcomeMeasureTimeFrame":"Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"92" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12 (n=84,39)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.583", "OutcomeMeasurementSpread":"0.672" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.225", "OutcomeMeasurementSpread":"0.497" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=84,36)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.834", "OutcomeMeasurementSpread":"0.805" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.261", "OutcomeMeasurementSpread":"0.612" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=81,37)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.123", "OutcomeMeasurementSpread":"0.910" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.300", "OutcomeMeasurementSpread":"0.621" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=89,42)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.280", "OutcomeMeasurementSpread":"1.043" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.491", "OutcomeMeasurementSpread":"0.740" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=91,13)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.240", "OutcomeMeasurementSpread":"1.205" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.452", "OutcomeMeasurementSpread":"0.793" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Quantitative HBsAg Level in Groups A and B", "OutcomeMeasureDescription":"Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.", "OutcomeMeasurePopulationDescription":"ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 IU/mL", "OutcomeMeasureTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"50" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=101,44)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.309", "OutcomeMeasurementSpread":"0.687" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.383", "OutcomeMeasurementSpread":"0.721" } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=97,49)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.844", "OutcomeMeasurementSpread":"1.186" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.299", "OutcomeMeasurementSpread":"0.809" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=99,46)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.509", "OutcomeMeasurementSpread":"1.507" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.336", "OutcomeMeasurementSpread":"0.732" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=99,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.265", "OutcomeMeasurementSpread":"1.661" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.272", "OutcomeMeasurementSpread":"0.726" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=99,47)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.078", "OutcomeMeasurementSpread":"1.769" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.215", "OutcomeMeasurementSpread":"0.718" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=100,14)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.370", "OutcomeMeasurementSpread":"1.630" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.394", "OutcomeMeasurementSpread":"0.939" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Quantitative HBsAg Level in Groups A and B", "OutcomeMeasureDescription":"The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.", "OutcomeMeasurePopulationDescription":"ITT Population. The \"Number of Participants Analyzed\" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 IU/mL", "OutcomeMeasureTimeFrame":"Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "OutcomeGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"44" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12 (n=97,44)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.444", "OutcomeMeasurementSpread":"1.021" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.081", "OutcomeMeasurementSpread":"0.356" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=99,42)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.798", "OutcomeMeasurementSpread":"1.343" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.032", "OutcomeMeasurementSpread":"0.392" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=99,44)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.051", "OutcomeMeasurementSpread":"1.534" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.126", "OutcomeMeasurementSpread":"0.260" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=99,44)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.239", "OutcomeMeasurementSpread":"1.652" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.188", "OutcomeMeasurementSpread":"0.285" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=100,13)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.936", "OutcomeMeasurementSpread":"1.491" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.204", "OutcomeMeasurementSpread":"0.316" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Quantitative Serum ALT Level in Group C", "OutcomeMeasureDescription":"The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).", "OutcomeMeasurePopulationDescription":"Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"factor of ULN", "OutcomeMeasureTimeFrame":"Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 1 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.313", "OutcomeMeasurementSpread":"0.414" } ] } } ] } },{ "OutcomeClassTitle":"Week 2 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.091", "OutcomeMeasurementSpread":"0.991" } ] } } ] } },{ "OutcomeClassTitle":"Week 4 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.361", "OutcomeMeasurementSpread":"1.566" } ] } } ] } },{ "OutcomeClassTitle":"Week 8 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.101", "OutcomeMeasurementSpread":"1.895" } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.012", "OutcomeMeasurementSpread":"1.613" } ] } } ] } },{ "OutcomeClassTitle":"Week 18 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.589", "OutcomeMeasurementSpread":"0.996" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.917", "OutcomeMeasurementSpread":"1.310" } ] } } ] } },{ "OutcomeClassTitle":"Week 30 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.584", "OutcomeMeasurementSpread":"1.730" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.633", "OutcomeMeasurementSpread":"1.455" } ] } } ] } },{ "OutcomeClassTitle":"Week 42 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.211", "OutcomeMeasurementSpread":"1.050" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.104", "OutcomeMeasurementSpread":"1.084" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 4 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.669", "OutcomeMeasurementSpread":"0.950" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 12 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.283", "OutcomeMeasurementSpread":"1.501" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.256", "OutcomeMeasurementSpread":"1.757" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Quantitative HBeAg Level in Group C", "OutcomeMeasureDescription":"Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL.", "OutcomeMeasurePopulationDescription":"Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 PEIU/mL", "OutcomeMeasureTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.344", "OutcomeMeasurementSpread":"0.981" } ] } } ] } },{ "OutcomeClassTitle":"Week 12 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.620", "OutcomeMeasurementSpread":"1.288" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.802", "OutcomeMeasurementSpread":"1.140" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.561", "OutcomeMeasurementSpread":"1.178" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.429", "OutcomeMeasurementSpread":"1.259" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.442", "OutcomeMeasurementSpread":"1.416" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Quantitative HBeAg Level in Group C", "OutcomeMeasureDescription":"The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.", "OutcomeMeasurePopulationDescription":"Safety Population. The \"Number of Participants Analyzed\" reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 PEIU/mL", "OutcomeMeasureTimeFrame":"Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12 (n=8)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.779", "OutcomeMeasurementSpread":"0.645" } ] } } ] } },{ "OutcomeClassTitle":"Week 24 (n=8)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.817", "OutcomeMeasurementSpread":"0.678" } ] } } ] } },{ "OutcomeClassTitle":"Week 36 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.817", "OutcomeMeasurementSpread":"0.685" } ] } } ] } },{ "OutcomeClassTitle":"Week 48 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.762", "OutcomeMeasurementSpread":"0.818" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24 (n=9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.742", "OutcomeMeasurementSpread":"0.840" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Quantitative HBsAg Level in Group C", "OutcomeMeasureDescription":"Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 IU/mL", "OutcomeMeasureTimeFrame":"Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.225", "OutcomeMeasurementSpread":"0.518" } ] } } ] } },{ "OutcomeClassTitle":"Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.829", "OutcomeMeasurementSpread":"0.589" } ] } } ] } },{ "OutcomeClassTitle":"Week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.515", "OutcomeMeasurementSpread":"1.113" } ] } } ] } },{ "OutcomeClassTitle":"Week 36", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.282", "OutcomeMeasurementSpread":"1.263" } ] } } ] } },{ "OutcomeClassTitle":"Week 48", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.215", "OutcomeMeasurementSpread":"1.352" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.137", "OutcomeMeasurementSpread":"1.463" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Quantitative HBsAg Level in Group C", "OutcomeMeasureDescription":"The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.", "OutcomeMeasurePopulationDescription":"Safety Population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"log10 IU/mL", "OutcomeMeasureTimeFrame":"Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "OutcomeGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.397", "OutcomeMeasurementSpread":"0.428" } ] } } ] } },{ "OutcomeClassTitle":"Week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.710", "OutcomeMeasurementSpread":"0.712" } ] } } ] } },{ "OutcomeClassTitle":"Week 36", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.943", "OutcomeMeasurementSpread":"0.913" } ] } } ] } },{ "OutcomeClassTitle":"Week 48", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.010", "OutcomeMeasurementSpread":"1.019" } ] } } ] } },{ "OutcomeClassTitle":"FU Week 24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.088", "OutcomeMeasurementSpread":"1.141" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"From Baseline to FU Week 24 (up to 72 weeks overall)", "EventsDescription":"Safety Population.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Group A: PEG-IFN Monotherapy Without Advanced Fibrosis", "EventGroupDescription":"Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.", "EventGroupSeriousNumAffected":"6", "EventGroupSeriousNumAtRisk":"101", "EventGroupOtherNumAffected":"80", "EventGroupOtherNumAtRisk":"101" },{ "EventGroupId":"EG001", "EventGroupTitle":"Group B: Untreated Control Without Advanced Fibrosis", "EventGroupDescription":"Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"49", "EventGroupOtherNumAffected":"18", "EventGroupOtherNumAtRisk":"49" },{ "EventGroupId":"EG002", "EventGroupTitle":"Group C: PEG-IFN Monotherapy With Advanced Fibrosis", "EventGroupDescription":"Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"10", "EventGroupOtherNumAffected":"9", "EventGroupOtherNumAtRisk":"10" },{ "EventGroupId":"EG003", "EventGroupTitle":"Group D: Switch to PEG-IFN Monotherapy", "EventGroupDescription":"Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy. Treatment was given over 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. Because participants could switch from Group B to Group D for up to 1 year following the Week 48 visit, not all participants had reached FU Week 24 at time of analysis.", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"33", "EventGroupOtherNumAffected":"21", "EventGroupOtherNumAtRisk":"33" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Hepatitis B", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA (18.1)", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"101" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"49" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"33" } ] } },{ "SeriousEventTerm":"Latent tuberculosis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA (18.1)", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"101" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"49" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"33" } ] } },{ "SeriousEventTerm":"Microsporum infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA (18.1)", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"101" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"49" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"33" } ] } },{ "SeriousEventTerm":"Pneumonia", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA (18.1)", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"101" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"49" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"33" } ] } },{ "SeriousEventTerm":"Tonsillitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA (18.1)", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"101" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"49" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"33" } ] } },{ "SeriousEventTerm":"Alanine aminotransferase increased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA (18.1)", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"101" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"49" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"33" } ] } },{ "SeriousEventTerm":"Aspartate aminotransferase increased", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA (18.1)", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"101" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"49" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"33" } ] } },{ "SeriousEventTerm":"Osteochondrosis", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"MedDRA (18.1)", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"101" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"49" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"33" } ] } },{ "SeriousEventTerm":"Suicidal ideation", "SeriousEventOrganSystem":"Psychiatric disorders", "SeriousEventSourceVocabulary":"MedDRA (18.1)", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"101" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"49" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"33" } ] } },{ "SeriousEventTerm":"Nephropathy", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA (18.1)", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"101" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"49" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"33" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Neutropenia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Abdominal pain", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"19", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Vomiting", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"14", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Asthenia", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"10", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Fatigue", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"9", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Influenza like illness", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"15", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Injection site pain", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Pyrexia", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"49", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"13", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Nasopharyngitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"7", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Oral herpes", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"101" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"49" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"33" } ] } },{ "OtherEventTerm":"Peritonsillar abscess", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA (18.1)", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ 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