Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-29 @ 12:35 PM
Study NCT ID:
NCT01519960
Status:
COMPLETED
Last Update Posted:
2022-11-18
First Post:
2011-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100416', 'term': 'peginterferon alfa-2a'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'global.trial_information@roche.com', 'phone': '61 6878333', 'title': 'Roche Trial Information Hotline', 'organization': 'F. Hoffmann-La Roche AG'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline to approximately 4.5 years', 'description': 'Safety Population', 'eventGroups': [{'id': 'EG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': '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.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 80, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 18, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group D: Switch to PEG-IFN Monotherapy', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 21, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Group A - Long Term Follow-up', 'description': 'Participants without advanced fibrosis: 4.5-year extended follow-up', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 25, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group B - Long Term Follow-up', 'description': 'Participants without advanced fibrosis: 4.5-year extended follow-up', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 6, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Group C Long Term Follow-up', 'description': 'Participants with advanced fibrosis: 4.5-year extended follow-up', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Group D - Long Term Follow-up', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 27, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 26, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 107, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 35, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 20, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 71, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 30, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 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33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Expired product administered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 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{'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Microsporum infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '17.56', 'groupId': 'OG000', 'lowerLimit': '17.56', 'upperLimit': '35.4'}, {'value': '6', 'spread': '1.25', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '16.55'}]}]}], 'analyses': [{'pValue': '= 0.0043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.43', 'ciLowerLimit': '1.54', 'ciUpperLimit': '19.2', 'groupDescription': '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 to (≥) 5 × ULN at Baseline. The OR was calculated using Group B as reference.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.3732', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Breslow-Day', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '17.56', 'groupId': 'OG000', 'lowerLimit': '17.56', 'upperLimit': '35.4'}, {'value': '6', 'spread': '1.25', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '16.55'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '3.48', 'groupId': 'OG000', 'lowerLimit': '3.48', 'upperLimit': '15.01'}, {'value': '0', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '41.33', 'groupId': 'OG000', 'lowerLimit': '41.33', 'upperLimit': '61.55'}, {'value': '12', 'spread': '4.53', 'groupId': 'OG001', 'lowerLimit': '4.53', 'upperLimit': '24.31'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.7', 'spread': '24.56', 'groupId': 'OG000', 'lowerLimit': '24.56', 'upperLimit': '43.75'}, {'value': '4', 'spread': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '13.71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '20.15', 'groupId': 'OG000', 'lowerLimit': '20.15', 'upperLimit': '38.57'}, {'value': '2', 'spread': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '10.65'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'spread': '15.02', 'groupId': 'OG000', 'lowerLimit': '15.02', 'upperLimit': '32.18'}, {'value': '4', 'spread': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '13.71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'spread': '12.54', 'groupId': 'OG000', 'lowerLimit': '12.54', 'upperLimit': '28.91'}, {'value': '2', 'spread': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '10.65'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '3.48', 'groupId': 'OG000', 'lowerLimit': '3.48', 'upperLimit': '15.01'}, {'value': '6', 'spread': '1.25', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '16.55'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '4.16', 'groupId': 'OG000', 'lowerLimit': '4.16', 'upperLimit': '16.24'}, {'value': '6', 'spread': '1.25', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '16.55'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '2.83', 'groupId': 'OG000', 'lowerLimit': '2.83', 'upperLimit': '13.76'}, {'value': '0', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '5.56', 'groupId': 'OG000', 'lowerLimit': '5.56', 'upperLimit': '18.65'}, {'value': '0', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Normal ALT at EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'spread': '11.72', 'groupId': 'OG000', 'lowerLimit': '11.72', 'upperLimit': '27.81'}, {'value': '22', 'spread': '11.53', 'groupId': 'OG001', 'lowerLimit': '11.53', 'upperLimit': '35.96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'spread': '27.27', 'groupId': 'OG000', 'lowerLimit': '27.27', 'upperLimit': '46.81'}, {'value': '12', 'spread': '4.53', 'groupId': 'OG001', 'lowerLimit': '4.53', 'upperLimit': '24.31'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'spread': '21.9', 'groupId': 'OG000', 'lowerLimit': '21.9', 'upperLimit': '40.66'}, {'value': '2', 'spread': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '10.65'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'spread': '11.72', 'groupId': 'OG000', 'lowerLimit': '11.72', 'upperLimit': '27.81'}, {'value': '0', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '2.83', 'groupId': 'OG000', 'lowerLimit': '2.83', 'upperLimit': '13.76'}, {'value': '6', 'spread': '1.25', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '16.55'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '2.83', 'groupId': 'OG000', 'lowerLimit': '2.83', 'upperLimit': '13.76'}, {'value': '0', 'spread': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantitative Serum ALT Level in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.779', 'spread': '2.483', 'groupId': 'OG000'}, {'value': '2.878', 'spread': '1.997', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.427', 'spread': '2.687', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.846', 'spread': '1.885', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.343', 'spread': '2.455', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.262', 'spread': '2.797', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.189', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.036', 'spread': '2.389', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.753', 'spread': '2.725', 'groupId': 'OG000'}, {'value': '2.401', 'spread': '2.638', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.587', 'spread': '2.128', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.45', 'spread': '1.856', 'groupId': 'OG000'}, {'value': '2.341', 'spread': '2.204', 'groupId': 'OG001'}]}]}, {'title': 'Week 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.316', 'spread': '1.429', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.122', 'spread': '1.389', 'groupId': 'OG000'}, {'value': '1.954', 'spread': '1.371', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.303', 'spread': '1.74', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.064', 'spread': '2.027', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.477', 'spread': '1.625', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.385', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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). ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.', 'unitOfMeasure': 'factor of ULN', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.'}, {'type': 'SECONDARY', 'title': 'Quantitative HBV DNA Level in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.094', 'spread': '0.986', 'groupId': 'OG000'}, {'value': '8.056', 'spread': '0.987', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.49', 'spread': '2.009', 'groupId': 'OG000'}, {'value': '7.909', 'spread': '1.267', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.966', 'spread': '2.398', 'groupId': 'OG000'}, {'value': '7.857', 'spread': '1.327', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.575', 'spread': '2.513', 'groupId': 'OG000'}, {'value': '7.685', 'spread': '1.608', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.224', 'spread': '2.701', 'groupId': 'OG000'}, {'value': '7.551', 'spread': '1.761', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.739', 'spread': '2.935', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.914', 'spread': '3.065', 'groupId': 'OG000'}, {'value': '7.214', 'spread': '2.46', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.707', 'spread': '3.113', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.506', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative HBV DNA Level in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.588', 'spread': '1.625', 'groupId': 'OG000'}, {'value': '-0.156', 'spread': '1.093', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.112', 'spread': '1.996', 'groupId': 'OG000'}, {'value': '-0.168', 'spread': '1.214', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.525', 'spread': '2.148', 'groupId': 'OG000'}, {'value': '-0.359', 'spread': '1.411', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.877', 'spread': '2.374', 'groupId': 'OG000'}, {'value': '-0.493', 'spread': '1.518', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.34', 'spread': '2.582', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.164', 'spread': '2.737', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '2.163', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.381', 'spread': '2.778', 'groupId': 'OG000'}, {'value': '-0.587', 'spread': '2.259', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. 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.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '6.67', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '65.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.85'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.85'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '34.75', 'groupId': 'OG000', 'lowerLimit': '34.75', 'upperLimit': '93.33'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '34.75', 'groupId': 'OG000', 'lowerLimit': '34.75', 'upperLimit': '93.33'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '34.75', 'groupId': 'OG000', 'lowerLimit': '34.75', 'upperLimit': '93.33'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '6.67', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '65.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '6.67', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '65.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '6.67', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '65.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBeAg Seroconversion at EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '2.52', 'groupId': 'OG000', 'lowerLimit': '2.52', 'upperLimit': '55.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Loss of HBeAg at EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '2.52', 'groupId': 'OG000', 'lowerLimit': '2.52', 'upperLimit': '55.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBsAg Seroconversion at EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.85'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Loss of HBsAg at EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.85'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Normal ALT at EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '12.16', 'groupId': 'OG000', 'lowerLimit': '12.16', 'upperLimit': '73.76'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '12.16', 'groupId': 'OG000', 'lowerLimit': '12.16', 'upperLimit': '73.76'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '6.67', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '65.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA Undetectable at EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '2.52', 'groupId': 'OG000', 'lowerLimit': '2.52', 'upperLimit': '55.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '2.52', 'groupId': 'OG000', 'lowerLimit': '2.52', 'upperLimit': '55.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '2.52', 'groupId': 'OG000', 'lowerLimit': '2.52', 'upperLimit': '55.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantitative Serum ALT Level in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.804', 'spread': '1.118', 'groupId': 'OG000'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '3.117', 'spread': '1.322', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '2.896', 'spread': '1.304', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.444', 'spread': '1.727', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2.703', 'spread': '2.035', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.793', 'spread': '1.288', 'groupId': 'OG000'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '2.215', 'spread': '1.032', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '1.887', 'spread': '1.095', 'groupId': 'OG000'}]}]}, {'title': 'Week 30', 'categories': [{'measurements': [{'value': '2.22', 'spread': '1.553', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '2.172', 'spread': '1.09', 'groupId': 'OG000'}]}]}, {'title': 'Week 42', 'categories': [{'measurements': [{'value': '1.593', 'spread': '0.516', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '1.645', 'spread': '1.242', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 4', 'categories': [{'measurements': [{'value': '1.136', 'spread': '0.506', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'categories': [{'measurements': [{'value': '1.521', 'spread': '0.755', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '1.549', 'spread': '1.595', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.', 'unitOfMeasure': 'factor of ULN', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantitative HBV DNA Level in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.866', 'spread': '0.977', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.782', 'spread': '1.771', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '5.599', 'spread': '2.386', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.451', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '5.319', 'spread': '2.747', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 4', 'categories': [{'measurements': [{'value': '4.604', 'spread': '2.442', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'categories': [{'measurements': [{'value': '4.252', 'spread': '2.596', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '3.694', 'spread': '3.127', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative HBV DNA Level in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-2.084', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-2.267', 'spread': '1.595', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-2.529', 'spread': '1.879', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-2.546', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 4', 'categories': [{'measurements': [{'value': '-3.262', 'spread': '2.102', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'categories': [{'measurements': [{'value': '-3.613', 'spread': '2.519', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '-4.15', 'spread': '2.904', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Groups Combined', 'description': 'All participants enrolled in the study'}], 'classes': [{'title': '0.54-0.74 m^2', 'categories': [{'measurements': [{'value': '3320', 'groupId': 'OG000', 'lowerLimit': '633', 'upperLimit': '5064'}]}]}, {'title': '0.75-1.08 m^2', 'categories': [{'measurements': [{'value': '4037', 'groupId': 'OG000', 'lowerLimit': '1897', 'upperLimit': '6916'}]}]}, {'title': '1.09-1.51 m^2', 'categories': [{'measurements': [{'value': '2765', 'groupId': 'OG000', 'lowerLimit': '1750', 'upperLimit': '4392'}]}]}, {'title': '>1.51 m^2', 'categories': [{'measurements': [{'value': '3448', 'groupId': 'OG000', 'lowerLimit': '1914', 'upperLimit': '5000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': '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). PK Substudy Population: All participants who consented to participate in the PK substudy. "Number of subjects 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.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 12', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)', 'description': 'The percentage of participants with \\>15% drop in height percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects 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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'The percentage of participants with \\>15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects 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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.'}, {'type': 'SECONDARY', 'title': 'Quantitative HBeAg Level in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.736', 'spread': '0.502', 'groupId': 'OG000'}, {'value': '2.568', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.09', 'spread': '0.879', 'groupId': 'OG000'}, {'value': '2.391', 'spread': '0.878', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '1.865', 'spread': '0.956', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '0.896', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '1.604', 'spread': '0.991', 'groupId': 'OG000'}, {'value': '2.272', 'spread': '0.985', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '1.466', 'spread': '1.053', 'groupId': 'OG000'}, {'value': '2.124', 'spread': '1.091', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '1.537', 'spread': '1.334', 'groupId': 'OG000'}, {'value': '2.217', 'spread': '1.395', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL). 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.', 'unitOfMeasure': 'log10 PEIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantitative HBsAg Level in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.309', 'spread': '0.687', 'groupId': 'OG000'}, {'value': '4.383', 'spread': '0.721', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '3.844', 'spread': '1.186', 'groupId': 'OG000'}, {'value': '4.299', 'spread': '0.809', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '3.509', 'spread': '1.507', 'groupId': 'OG000'}, {'value': '4.336', 'spread': '0.732', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '3.265', 'spread': '1.661', 'groupId': 'OG000'}, {'value': '4.272', 'spread': '0.726', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '3.078', 'spread': '1.769', 'groupId': 'OG000'}, {'value': '4.215', 'spread': '0.718', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '3.37', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '4.394', 'spread': '0.939', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. 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.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantitative HBeAg Level in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.344', 'spread': '0.981', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.62', 'spread': '1.288', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '1.802', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '1.561', 'spread': '1.178', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '1.429', 'spread': '1.259', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '1.442', 'spread': '1.416', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.', 'unitOfMeasure': 'log10 PEIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantitative HBsAg Level in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.225', 'spread': '0.518', 'groupId': 'OG000', 'lowerLimit': '0.518'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '3.829', 'spread': '0.589', 'groupId': 'OG000', 'lowerLimit': '0.589'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '3.515', 'spread': '1.113', 'groupId': 'OG000', 'lowerLimit': '1.113'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '3.282', 'spread': '1.263', 'groupId': 'OG000', 'lowerLimit': '1.263'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '3.215', 'spread': '1.352', 'groupId': 'OG000', 'lowerLimit': '1.352'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '3.137', 'spread': '1.463', 'groupId': 'OG000', 'lowerLimit': '1.463'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}, {'id': 'OG002', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '2.151', 'groupId': 'OG000'}, {'value': '0.376', 'spread': '2.719', 'groupId': 'OG001'}, {'value': '-1.517', 'spread': '1.685', 'groupId': 'OG002'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '-1.026', 'spread': '2.269', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '2.633', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.033', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 48; FU Week 24 (up to 72 weeks overall)', 'description': '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. Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. "Number of subjects 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.', 'unitOfMeasure': 'kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >15% Drop in Height Percentile for Age in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Week 30', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'The percentage of participants with \\>15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height for Age Z-Score in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.271', 'spread': '1.149', 'groupId': 'OG000'}, {'value': '-0.062', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.258', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.185', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.293', 'groupId': 'OG000'}, {'value': '-0.071', 'spread': '0.264', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-0.056', 'spread': '0.337', 'groupId': 'OG000'}, {'value': '-0.025', 'spread': '0.328', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-0.099', 'spread': '0.365', 'groupId': 'OG000'}, {'value': '-0.013', 'spread': '0.284', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 12', 'categories': [{'measurements': [{'value': '-0.112', 'spread': '0.404', 'groupId': 'OG000'}, {'value': '-0.037', 'spread': '0.243', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '-0.117', 'spread': '0.429', 'groupId': 'OG000'}, {'value': '-0.079', 'spread': '0.282', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)', 'description': '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. Safety Population. "Number of subjects 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.', 'unitOfMeasure': 'standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weight for Age Z-Score in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.106', 'spread': '1.154', 'groupId': 'OG000'}, {'value': '-0.047', 'spread': '1.154', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.024', 'spread': '0.089', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.023', 'spread': '0.108', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.048', 'spread': '0.158', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.082', 'spread': '0.228', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.267', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.241', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.155', 'spread': '0.309', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.165', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.323', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.189', 'spread': '0.372', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.192', 'spread': '0.395', 'groupId': 'OG000'}, {'value': '-0.057', 'spread': '0.338', 'groupId': 'OG001'}]}]}, {'title': 'Week 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.375', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.214', 'spread': '0.371', 'groupId': 'OG000'}, {'value': '-0.082', 'spread': '0.343', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.156', 'spread': '0.346', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.089', 'spread': '0.384', 'groupId': 'OG000'}, {'value': '-0.263', 'spread': '0.333', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.046', 'spread': '0.452', 'groupId': 'OG000'}, {'value': '-0.322', 'spread': '0.325', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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.Safety Population. "Number of subjects 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.', 'unitOfMeasure': 'standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height for Age Z-Score in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.586', 'spread': '0.947', 'groupId': 'OG000', 'lowerLimit': '0.947'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.492', 'groupId': 'OG000', 'lowerLimit': '0.492'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.262', 'spread': '0.42', 'groupId': 'OG000', 'lowerLimit': '0.42'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.601', 'groupId': 'OG000', 'lowerLimit': '0.601'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.683', 'groupId': 'OG000', 'lowerLimit': '0.683'}]}]}, {'title': 'FU Week 12', 'categories': [{'measurements': [{'value': '0.205', 'spread': '0.611', 'groupId': 'OG000', 'lowerLimit': '0.611'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '0.064', 'spread': '0.634', 'groupId': 'OG000', 'lowerLimit': '0.634'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)', 'description': '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. Safety Population.', 'unitOfMeasure': 'standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weight for Age Z-Score in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.187', 'spread': '1.141', 'groupId': 'OG000'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-0.044', 'spread': '0.052', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-0.023', 'spread': '0.107', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.049', 'spread': '0.243', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.041', 'spread': '0.198', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.288', 'groupId': 'OG000'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '-0.018', 'spread': '0.377', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.089', 'spread': '0.245', 'groupId': 'OG000'}]}]}, {'title': 'Week 30', 'categories': [{'measurements': [{'value': '-0.094', 'spread': '0.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '0', 'spread': '0.443', 'groupId': 'OG000'}]}]}, {'title': 'Week 42', 'categories': [{'measurements': [{'value': '-0.032', 'spread': '0.344', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-0.208', 'spread': '0.374', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 4', 'categories': [{'measurements': [{'value': '-0.054', 'spread': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'categories': [{'measurements': [{'value': '-0.156', 'spread': '0.29', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '-0.161', 'spread': '0.309', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.', 'unitOfMeasure': 'standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '6.67', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '65.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative Serum ALT Level in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.606', 'spread': '1.565', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '2.283', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.564', 'spread': '3.026', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.463', 'spread': '3.225', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.415', 'spread': '3.732', 'groupId': 'OG000'}, {'value': '0.598', 'spread': '5.934', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.288', 'spread': '3.332', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '3.496', 'groupId': 'OG000'}, {'value': '-0.462', 'spread': '2.311', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.163', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.302', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '1.835', 'groupId': 'OG001'}]}]}, {'title': 'Week 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.436', 'spread': '2.732', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.63', 'spread': '2.652', 'groupId': 'OG000'}, {'value': '-0.939', 'spread': '1.914', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.474', 'spread': '2.889', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.736', 'spread': '2.972', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.302', 'spread': '2.766', 'groupId': 'OG000'}, {'value': '-0.701', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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). 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.', 'unitOfMeasure': 'factor of ULN', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative HBeAg Level in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.583', 'spread': '0.672', 'groupId': 'OG000'}, {'value': '-0.225', 'spread': '0.497', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.834', 'spread': '0.805', 'groupId': 'OG000'}, {'value': '-0.261', 'spread': '0.612', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '1.123', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.621', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-1.28', 'spread': '1.043', 'groupId': 'OG000'}, {'value': '-0.491', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '-1.24', 'spread': '1.205', 'groupId': 'OG000'}, {'value': '-0.452', 'spread': '0.793', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. ITT Population. "Number of subjects 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.', 'unitOfMeasure': 'log10 PEIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative HBsAg Level in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.444', 'spread': '1.021', 'groupId': 'OG000'}, {'value': '-0.081', 'spread': '0.356', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.798', 'spread': '1.343', 'groupId': 'OG000'}, {'value': '-0.032', 'spread': '0.392', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-1.051', 'spread': '1.534', 'groupId': 'OG000'}, {'value': '-0.126', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-1.239', 'spread': '1.652', 'groupId': 'OG000'}, {'value': '-0.188', 'spread': '0.285', 'groupId': 'OG001'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '-0.936', 'spread': '1.491', 'groupId': 'OG000'}, {'value': '-0.204', 'spread': '0.316', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. "Number of subjects 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.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative Serum ALT Level in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.313', 'spread': '0.414', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.091', 'spread': '0.991', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.361', 'spread': '1.566', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.101', 'spread': '1.895', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.012', 'spread': '1.613', 'groupId': 'OG000'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '-0.589', 'spread': '0.996', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.917', 'spread': '1.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 30', 'categories': [{'measurements': [{'value': '-0.584', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-0.633', 'spread': '1.455', 'groupId': 'OG000'}]}]}, {'title': 'Week 42', 'categories': [{'measurements': [{'value': '-1.211', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-1.104', 'spread': '1.084', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 4', 'categories': [{'measurements': [{'value': '-1.669', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 12', 'categories': [{'measurements': [{'value': '-1.283', 'spread': '1.501', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '-1.256', 'spread': '1.757', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.', 'unitOfMeasure': 'factor of ULN', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative HBeAg Level in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.779', 'spread': '0.645', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.817', 'spread': '0.678', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-0.817', 'spread': '0.685', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-0.762', 'spread': '0.818', 'groupId': 'OG000'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '-0.742', 'spread': '0.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. "Number of subjects 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.', 'unitOfMeasure': 'log10 PEIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative HBsAg Level in Group C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.397', 'spread': '0.428', 'groupId': 'OG000', 'lowerLimit': '0.428'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.712', 'groupId': 'OG000', 'lowerLimit': '0.712'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-0.943', 'spread': '0.913', 'groupId': 'OG000', 'lowerLimit': '0.913'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-1.01', 'spread': '1.019', 'groupId': 'OG000', 'lowerLimit': '1.019'}]}]}, {'title': 'FU Week 24', 'categories': [{'measurements': [{'value': '-1.088', 'spread': '1.141', 'groupId': 'OG000', 'lowerLimit': '1.141'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'OG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '3.59'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '7.11'}]}]}, {'title': 'Fu Year 1', 'categories': [{'measurements': [{'value': '32.7', 'spread': '23.67', 'groupId': 'OG000', 'lowerLimit': '23.67', 'upperLimit': '42.72'}, {'value': '6.08', 'spread': '1.25', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '16.55'}]}]}, {'title': 'Fu Year 2', 'categories': [{'measurements': [{'value': '33.7', 'spread': '24.56', 'groupId': 'OG000', 'lowerLimit': '24.56', 'upperLimit': '43.75'}, {'value': '6.08', 'spread': '1.25', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '16.55'}]}]}, {'title': 'Fu Year 3', 'categories': [{'measurements': [{'value': '46.5', 'spread': '36.55', 'groupId': 'OG000', 'lowerLimit': '36.55', 'upperLimit': '56.73'}, {'value': '6.08', 'spread': '1.25', 'groupId': 'OG001', 'lowerLimit': '1.25', 'upperLimit': '16.55'}]}]}, {'title': 'Fu Year 4', 'categories': [{'measurements': [{'value': '30.7', 'spread': '21.90', 'groupId': 'OG000', 'lowerLimit': '21.90', 'upperLimit': '40.66'}, {'value': '8.00', 'spread': '2.22', 'groupId': 'OG001', 'lowerLimit': '2.22', 'upperLimit': '19.23'}]}]}, {'title': 'Fu Year 5', 'categories': [{'measurements': [{'value': '5.9', 'spread': '2.21', 'groupId': 'OG000', 'lowerLimit': '2.21', 'upperLimit': '12.48'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '7.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, FU Years: 1, 2, 3, 4, 5', 'description': 'HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group D: Switch to PEG-IFN Monotherapy', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '15.59', 'upperLimit': '48.71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group D: Switch to PEG-IFN Monotherapy', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.92', 'upperLimit': '24.33'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group D: Switch to PEG-IFN Monotherapy', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '3.40', 'upperLimit': '28.20'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group D: Switch to PEG-IFN Monotherapy', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'groupId': 'OG000', 'lowerLimit': '25.48', 'upperLimit': '60.78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group D: Switch to PEG-IFN Monotherapy', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '20.40', 'upperLimit': '54.88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group D: Switch to PEG-IFN Monotherapy', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '13.30', 'upperLimit': '45.52'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group D: Switch to PEG-IFN Monotherapy', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '6.98', 'upperLimit': '35.46'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group D: Switch to PEG-IFN Monotherapy', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '13.30', 'upperLimit': '45.52'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': 'HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group D: Switch to PEG-IFN Monotherapy', 'description': 'Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up'}], 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '8.98', 'upperLimit': '38.91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'FG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}, {'id': 'FG002', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Completed Week 48', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Completed Follow-Up (FU) Week 12', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Completed FU Week 24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Completed FU 5 Year', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Switch Group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal from the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: PEG-IFN Monotherapy Without Advanced Fibrosis', 'description': 'Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on 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.'}, {'id': 'BG001', 'title': 'Group B: Untreated Control Without Advanced Fibrosis', 'description': '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.'}, {'id': 'BG002', 'title': 'Group C: PEG-IFN Monotherapy With Advanced Fibrosis', 'description': '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 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.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.41', 'spread': '4.57', 'groupId': 'BG000'}, {'value': '11.2', 'spread': '5.01', 'groupId': 'BG001'}, {'value': '6.7', 'spread': '3.27', 'groupId': 'BG002'}, {'value': '10.55', 'spread': '4.81', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'In utero', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Preterm newborn infants (gestational age < 37 wks)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Newborns (0-27 days)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Infants and toddlers (28 days-23 months)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Children (2-11 years)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}]}, {'title': 'Adolescents (12-17 years)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}, {'title': 'Adults (18-64 years)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'From 65-84 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': '85 years and over', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-28', 'size': 674367, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-03T14:50', 'hasProtocol': True}, {'date': '2016-02-19', 'size': 648185, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-03T14:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2011-12-06', 'resultsFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-08', 'studyFirstPostDateStruct': {'date': '2012-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': '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', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': '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', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': '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', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B', 'timeFrame': 'Week 48', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.'}, {'measure': 'Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B', 'timeFrame': 'Week 48', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.'}, {'measure': 'Percentage of Participants With Normal ALT at EOT/POP in Groups A and B', 'timeFrame': 'Week 48', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B', 'timeFrame': 'Week 48', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B', 'timeFrame': 'Week 48', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B', 'timeFrame': 'Week 48', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B', 'timeFrame': 'Week 48', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B', 'timeFrame': 'Week 48', 'description': '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. ITT Population.'}, {'measure': 'Quantitative Serum ALT Level in Groups A and B', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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). ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.'}, {'measure': 'Quantitative HBV DNA Level in Groups A and B', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.'}, {'measure': 'Change From Baseline in Quantitative HBV DNA Level in Groups A and B', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. 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.'}, {'measure': 'Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.'}, {'measure': 'Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population'}, {'measure': 'Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With HBeAg Seroconversion at EOT in Group C', 'timeFrame': 'Week 48', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With Loss of HBeAg at EOT in Group C', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.'}, {'measure': 'Percentage of Participants With HBsAg Seroconversion at EOT in Group C', 'timeFrame': 'Week 48', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With Loss of HBsAg at EOT in Group C', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.'}, {'measure': 'Percentage of Participants With Normal ALT at EOT in Group C', 'timeFrame': 'Week 48', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C', 'timeFrame': 'Week 48', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C', 'timeFrame': 'Week 48', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With HBV DNA Undetectable at EOT in Group C', 'timeFrame': 'Week 48', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C', 'timeFrame': 'Week 48', 'description': '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. Safety Population.'}, {'measure': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C', 'timeFrame': 'Week 48', 'description': '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. Safety Population.'}, {'measure': 'Quantitative Serum ALT Level in Group C', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.'}, {'measure': 'Quantitative HBV DNA Level in Group C', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.'}, {'measure': 'Change From Baseline in Quantitative HBV DNA Level in Group C', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.'}, {'measure': 'Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category', 'timeFrame': '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)', 'description': '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). PK Substudy Population: All participants who consented to participate in the PK substudy. "Number of subjects 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.'}, {'measure': 'Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)', 'description': 'The percentage of participants with \\>15% drop in height percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects 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.'}, {'measure': 'Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B', 'timeFrame': 'Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'The percentage of participants with \\>15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population. "Number of subjects 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.'}, {'measure': 'Quantitative HBeAg Level in Groups A and B', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL). 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.'}, {'measure': 'Quantitative HBsAg Level in Groups A and B', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. 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.'}, {'measure': 'Quantitative HBeAg Level in Group C', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.'}, {'measure': 'Quantitative HBsAg Level in Group C', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.'}, {'measure': 'Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C', 'timeFrame': 'Week 48; FU Week 24 (up to 72 weeks overall)', 'description': '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. Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. "Number of subjects 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.'}, {'measure': 'Percentage of Participants With >15% Drop in Height Percentile for Age in Group C', 'timeFrame': 'Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': 'The percentage of participants with \\>15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population.'}, {'measure': 'Change From Baseline in Height for Age Z-Score in Groups A and B', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)', 'description': '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. Safety Population. "Number of subjects 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.'}, {'measure': 'Change From Baseline in Weight for Age Z-Score in Groups A and B', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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.Safety Population. "Number of subjects 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.'}, {'measure': 'Change From Baseline in Height for Age Z-Score in Group C', 'timeFrame': 'Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)', 'description': '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. Safety Population.'}, {'measure': 'Change From Baseline in Weight for Age Z-Score in Group C', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.'}, {'measure': 'Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Safety Population.'}, {'measure': 'Change From Baseline in Quantitative Serum ALT Level in Groups A and B', 'timeFrame': 'Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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). 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.'}, {'measure': 'Change From Baseline in Quantitative HBeAg Level in Groups A and B', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. ITT Population. "Number of subjects 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.'}, {'measure': 'Change From Baseline in Quantitative HBsAg Level in Groups A and B', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. "Number of subjects 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.'}, {'measure': 'Change From Baseline in Quantitative Serum ALT Level in Group C', 'timeFrame': 'Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)', 'description': '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). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.'}, {'measure': 'Change From Baseline in Quantitative HBeAg Level in Group C', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. "Number of subjects 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.'}, {'measure': 'Change From Baseline in Quantitative HBsAg Level in Group C', 'timeFrame': 'Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)', 'description': 'The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.'}, {'measure': 'Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B', 'timeFrame': 'Baseline, FU Years: 1, 2, 3, 4, 5', 'description': 'HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.'}, {'measure': 'Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.'}, {'measure': 'Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.'}, {'measure': 'Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}, {'measure': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': 'HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.'}, {'measure': 'Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group', 'timeFrame': 'FU Week 24 (up to 72 weeks overall)', 'description': '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. ITT Population.'}]}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'referencesModule': {'references': [{'pmid': '29689122', 'type': 'DERIVED', 'citation': '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.'}]}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients, 3 years to \\<18 years of age at baseline\n* Positive HBsAg for more than 6 months\n* Positive HBeAg and detectable HBV DNA at screening\n* A 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\n* Compensated liver disease (Child-Pugh Class A)\n* Elevated serum alanine transferase (ALT)\n* Normal thyroid gland function at screening\n\nExclusion Criteria:\n\n* Subjects with cirrhosis\n* Subjects 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\n* Known hypersensitivity to peginterferon\n* Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV infection\n* History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis B\n* History or evidence of bleeding from esophageal varices\n* Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C)\n* History of immunologically mediated disease\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT01519960', 'briefTitle': 'A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, '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', 'orgStudyIdInfo': {'id': 'YV25718'}, 'secondaryIdInfos': [{'id': '2011-002732-70', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A Pegasys', 'interventionNames': ['Drug: peginterferon alfa-2a [Pegasys]']}, {'type': 'NO_INTERVENTION', 'label': 'B Untreated Control'}, {'type': 'EXPERIMENTAL', 'label': 'C Fibrosis non-randomized', 'interventionNames': ['Drug: peginterferon alfa-2a [Pegasys]']}, {'type': 'EXPERIMENTAL', 'label': 'Switch', 'interventionNames': ['Drug: peginterferon alfa-2a [Pegasys]']}], 'interventions': [{'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': 'Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48', 'armGroupLabels': ['A Pegasys', 'C Fibrosis non-randomized']}, {'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Switch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "Univ of California SF, Benioff Children's Hospital; 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