Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT01066793
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2010-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'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'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'global.trial_information@roche.com', 'phone': '+41 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': 'Up to 24 Weeks after EOT. The EOT is 12, 24, 48 or 72 weeks after initiation of treatment.', 'description': 'Documentation of adverse events or serious adverse events was not within scope of this study. Serious Adverse Drug Reactions (SADRs) were reported through spontaneous reporting system for marketed drugs. In most SADRs, the study number was missing on form; thus it could not be assigned to study and hence no data was available for reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2)', 'categories': [{'measurements': [{'value': '46.1', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '49.7'}, {'value': '78.0', 'groupId': 'OG001', 'lowerLimit': '73.7', 'upperLimit': '81.9'}, {'value': '68.3', 'groupId': 'OG002', 'lowerLimit': '63.1', 'upperLimit': '73.1'}, {'value': '43.0', 'groupId': 'OG003', 'lowerLimit': '33.7', 'upperLimit': '52.6'}, {'value': '55.6', 'groupId': 'OG004', 'lowerLimit': '21.2', 'upperLimit': '86.3'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000', 'lowerLimit': '32.4', 'upperLimit': '47.1'}, {'value': '81.7', 'groupId': 'OG001', 'lowerLimit': '72.9', 'upperLimit': '88.6'}, {'value': '68.9', 'groupId': 'OG002', 'lowerLimit': '57.1', 'upperLimit': '79.2'}, {'value': '35.7', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '64.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of \\<15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection \\[LLOD\\] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2)', 'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000', 'lowerLimit': '43.4', 'upperLimit': '50.9'}, {'value': '79.5', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '83.5'}, {'value': '68.9', 'groupId': 'OG002', 'lowerLimit': '63.3', 'upperLimit': '74.1'}, {'value': '40.2', 'groupId': 'OG003', 'lowerLimit': '30.6', 'upperLimit': '50.4'}, {'value': '57.1', 'groupId': 'OG004', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '47.3'}, {'value': '80.5', 'groupId': 'OG001', 'lowerLimit': '70.6', 'upperLimit': '88.2'}, {'value': '69.1', 'groupId': 'OG002', 'lowerLimit': '56.7', 'upperLimit': '79.8'}, {'value': '35.7', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '64.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of \\<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '5.8'}, {'value': '21.7', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '26.0'}, {'value': '9.9', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '13.5'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '7.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '7.8'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '13.4'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '2.2', 'upperLimit': '15.1'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '28.8'}, {'value': '80.4', 'groupId': 'OG001', 'lowerLimit': '76.3', 'upperLimit': '84.1'}, {'value': '70.8', 'groupId': 'OG002', 'lowerLimit': '65.8', 'upperLimit': '75.5'}, {'value': '36.8', 'groupId': 'OG003', 'lowerLimit': '28.0', 'upperLimit': '46.4'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '22.1'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '65.6', 'upperLimit': '83.0'}, {'value': '67.6', 'groupId': 'OG002', 'lowerLimit': '55.7', 'upperLimit': '78.0'}, {'value': '42.9', 'groupId': 'OG003', 'lowerLimit': '17.7', 'upperLimit': '71.1'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000', 'lowerLimit': '55.2', 'upperLimit': '62.2'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '88.7', 'upperLimit': '94.2'}, {'value': '91.5', 'groupId': 'OG002', 'lowerLimit': '88.1', 'upperLimit': '94.2'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '57.2', 'upperLimit': '75.2'}, {'value': '88.9', 'groupId': 'OG004', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk12,PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000', 'lowerLimit': '35.0', 'upperLimit': '49.8'}, {'value': '91.3', 'groupId': 'OG001', 'lowerLimit': '84.2', 'upperLimit': '96.0'}, {'value': '87.8', 'groupId': 'OG002', 'lowerLimit': '78.2', 'upperLimit': '94.3'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '23.0', 'upperLimit': '77.0'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000', 'lowerLimit': '68.2', 'upperLimit': '74.6'}, {'value': '91.3', 'groupId': 'OG001', 'lowerLimit': '88.2', 'upperLimit': '93.8'}, {'value': '91.8', 'groupId': 'OG002', 'lowerLimit': '88.4', 'upperLimit': '94.4'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '57.2', 'upperLimit': '75.2'}, {'value': '88.9', 'groupId': 'OG004', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '46.3', 'upperLimit': '61.2'}, {'value': '90.4', 'groupId': 'OG001', 'lowerLimit': '83.0', 'upperLimit': '95.3'}, {'value': '89.2', 'groupId': 'OG002', 'lowerLimit': '79.8', 'upperLimit': '95.2'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}, {'title': '12wk PEOT,PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000', 'lowerLimit': '45.7', 'upperLimit': '52.8'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '75.8', 'upperLimit': '83.7'}, {'value': '70.8', 'groupId': 'OG002', 'lowerLimit': '65.8', 'upperLimit': '75.5'}, {'value': '46.5', 'groupId': 'OG003', 'lowerLimit': '37.1', 'upperLimit': '56.1'}, {'value': '55.6', 'groupId': 'OG004', 'lowerLimit': '21.2', 'upperLimit': '86.3'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': '12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2)', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000', 'lowerLimit': '33.5', 'upperLimit': '48.2'}, {'value': '81.7', 'groupId': 'OG001', 'lowerLimit': '72.9', 'upperLimit': '88.6'}, {'value': '70.3', 'groupId': 'OG002', 'lowerLimit': '58.5', 'upperLimit': '80.3'}, {'value': '35.7', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '64.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT', 'description': 'Virological response (VR) was defined as HCV RNA \\<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '5.7'}, {'value': '23.3', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '28.0'}, {'value': '10.4', 'groupId': 'OG002', 'lowerLimit': '7.2', 'upperLimit': '14.4'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '6.9'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '41.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.2'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '15.9'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '16.3'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2)', 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000', 'lowerLimit': '23.2', 'upperLimit': '29.8'}, {'value': '82.5', 'groupId': 'OG001', 'lowerLimit': '78.2', 'upperLimit': '86.3'}, {'value': '71.2', 'groupId': 'OG002', 'lowerLimit': '65.7', 'upperLimit': '76.3'}, {'value': '38.2', 'groupId': 'OG003', 'lowerLimit': '28.8', 'upperLimit': '48.4'}, {'value': '28.6', 'groupId': 'OG004', 'lowerLimit': '3.7', 'upperLimit': '71.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '21.8'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '65.5', 'upperLimit': '84.4'}, {'value': '64.7', 'groupId': 'OG002', 'lowerLimit': '52.2', 'upperLimit': '75.9'}, {'value': '42.9', 'groupId': 'OG003', 'lowerLimit': '17.7', 'upperLimit': '71.1'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7, 2)', 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000', 'lowerLimit': '56.2', 'upperLimit': '63.6'}, {'value': '93.1', 'groupId': 'OG001', 'lowerLimit': '89.9', 'upperLimit': '95.5'}, {'value': '92.3', 'groupId': 'OG002', 'lowerLimit': '88.7', 'upperLimit': '95.1'}, {'value': '68.6', 'groupId': 'OG003', 'lowerLimit': '58.7', 'upperLimit': '77.5'}, {'value': '85.7', 'groupId': 'OG004', 'lowerLimit': '42.1', 'upperLimit': '99.6'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '42.4', 'groupId': 'OG000', 'lowerLimit': '34.6', 'upperLimit': '50.5'}, {'value': '92.0', 'groupId': 'OG001', 'lowerLimit': '84.1', 'upperLimit': '96.7'}, {'value': '86.8', 'groupId': 'OG002', 'lowerLimit': '76.4', 'upperLimit': '93.8'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '23.0', 'upperLimit': '77.0'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'EOT, PEG-IFN alfa-2a (n=704,361,299,102, 7, 2)', 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '69.4', 'upperLimit': '76.1'}, {'value': '92.2', 'groupId': 'OG001', 'lowerLimit': '89.0', 'upperLimit': '94.8'}, {'value': '92.3', 'groupId': 'OG002', 'lowerLimit': '88.7', 'upperLimit': '95.1'}, {'value': '65.7', 'groupId': 'OG003', 'lowerLimit': '55.6', 'upperLimit': '74.8'}, {'value': '85.7', 'groupId': 'OG004', 'lowerLimit': '42.1', 'upperLimit': '99.6'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2)', 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '60.5'}, {'value': '89.7', 'groupId': 'OG001', 'lowerLimit': '81.3', 'upperLimit': '95.2'}, {'value': '89.7', 'groupId': 'OG002', 'lowerLimit': '79.9', 'upperLimit': '95.8'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}, {'title': '12wk PEOT,PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000', 'lowerLimit': '46.5', 'upperLimit': '54.0'}, {'value': '81.4', 'groupId': 'OG001', 'lowerLimit': '77.0', 'upperLimit': '85.3'}, {'value': '71.2', 'groupId': 'OG002', 'lowerLimit': '65.7', 'upperLimit': '76.3'}, {'value': '44.1', 'groupId': 'OG003', 'lowerLimit': '34.3', 'upperLimit': '54.3'}, {'value': '57.1', 'groupId': 'OG004', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': '12wk PEOT, PEG-IFN alfa-2b (n=158, 87, 68,14,2,2)', 'categories': [{'measurements': [{'value': '39.9', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '48.0'}, {'value': '80.5', 'groupId': 'OG001', 'lowerLimit': '70.6', 'upperLimit': '88.2'}, {'value': '70.6', 'groupId': 'OG002', 'lowerLimit': '58.3', 'upperLimit': '81.0'}, {'value': '35.7', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '64.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT', 'description': 'Virological response (VR) was defined as HCV RNA \\<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '6.5'}, {'value': '24.9', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '29.3'}, {'value': '12.7', 'groupId': 'OG002', 'lowerLimit': '9.5', 'upperLimit': '16.7'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '8.7'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '7.8'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '18.1'}, {'value': '12.2', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '21.8'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': '33.8'}, {'value': '85.5', 'groupId': 'OG001', 'lowerLimit': '81.7', 'upperLimit': '88.8'}, {'value': '75.1', 'groupId': 'OG002', 'lowerLimit': '70.2', 'upperLimit': '79.5'}, {'value': '41.2', 'groupId': 'OG003', 'lowerLimit': '32.1', 'upperLimit': '50.8'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '27.5'}, {'value': '86.5', 'groupId': 'OG001', 'lowerLimit': '78.4', 'upperLimit': '92.4'}, {'value': '74.3', 'groupId': 'OG002', 'lowerLimit': '62.8', 'upperLimit': '83.8'}, {'value': '42.9', 'groupId': 'OG003', 'lowerLimit': '17.7', 'upperLimit': '71.1'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '60.1', 'upperLimit': '67.0'}, {'value': '94.0', 'groupId': 'OG001', 'lowerLimit': '91.2', 'upperLimit': '96.1'}, {'value': '93.2', 'groupId': 'OG002', 'lowerLimit': '90.1', 'upperLimit': '95.6'}, {'value': '70.2', 'groupId': 'OG003', 'lowerLimit': '60.9', 'upperLimit': '78.4'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '66.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000', 'lowerLimit': '40.4', 'upperLimit': '55.3'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '87.9', 'upperLimit': '97.9'}, {'value': '93.2', 'groupId': 'OG002', 'lowerLimit': '84.9', 'upperLimit': '97.8'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '23.0', 'upperLimit': '77.0'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'EOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000', 'lowerLimit': '70.5', 'upperLimit': '76.8'}, {'value': '92.8', 'groupId': 'OG001', 'lowerLimit': '89.8', 'upperLimit': '95.1'}, {'value': '92.4', 'groupId': 'OG002', 'lowerLimit': '89.1', 'upperLimit': '94.9'}, {'value': '67.5', 'groupId': 'OG003', 'lowerLimit': '58.1', 'upperLimit': '76.0'}, {'value': '88.9', 'groupId': 'OG004', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'EOT, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '49.6', 'upperLimit': '64.4'}, {'value': '92.3', 'groupId': 'OG001', 'lowerLimit': '85.4', 'upperLimit': '96.6'}, {'value': '89.2', 'groupId': 'OG002', 'lowerLimit': '79.8', 'upperLimit': '95.2'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}, {'title': '12wk PEOT, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '46.4', 'upperLimit': '53.6'}, {'value': '80.2', 'groupId': 'OG001', 'lowerLimit': '76.0', 'upperLimit': '83.9'}, {'value': '71.4', 'groupId': 'OG002', 'lowerLimit': '66.4', 'upperLimit': '76.0'}, {'value': '46.5', 'groupId': 'OG003', 'lowerLimit': '37.1', 'upperLimit': '56.1'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': '12wk PEOT, PEG-IFN alfa-2b (n=182,104, 4,14,2,2)', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000', 'lowerLimit': '33.5', 'upperLimit': '48.2'}, {'value': '83.7', 'groupId': 'OG001', 'lowerLimit': '75.1', 'upperLimit': '90.2'}, {'value': '70.3', 'groupId': 'OG002', 'lowerLimit': '58.5', 'upperLimit': '80.3'}, {'value': '35.7', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '64.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT', 'description': 'Modified virological response (mVR) was defined as HCV RNA \\<50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7, 2)', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '6.5'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '21.6', 'upperLimit': '30.9'}, {'value': '12.7', 'groupId': 'OG002', 'lowerLimit': '9.2', 'upperLimit': '17.0'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '8.4'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '41.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.2'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '21.5'}, {'value': '13.2', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '23.6'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '33.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2a (n=704, 361,299,102,7,2)', 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': '35.3'}, {'value': '87.3', 'groupId': 'OG001', 'lowerLimit': '83.4', 'upperLimit': '90.5'}, {'value': '74.9', 'groupId': 'OG002', 'lowerLimit': '69.6', 'upperLimit': '79.7'}, {'value': '43.1', 'groupId': 'OG003', 'lowerLimit': '33.4', 'upperLimit': '53.3'}, {'value': '28.6', 'groupId': 'OG004', 'lowerLimit': '3.7', 'upperLimit': '71.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '28.1'}, {'value': '88.5', 'groupId': 'OG001', 'lowerLimit': '79.9', 'upperLimit': '94.3'}, {'value': '72.1', 'groupId': 'OG002', 'lowerLimit': '59.9', 'upperLimit': '82.3'}, {'value': '42.9', 'groupId': 'OG003', 'lowerLimit': '17.7', 'upperLimit': '71.1'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '65.1', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '68.6'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '92.2', 'upperLimit': '97.0'}, {'value': '94.0', 'groupId': 'OG002', 'lowerLimit': '90.7', 'upperLimit': '96.4'}, {'value': '71.6', 'groupId': 'OG003', 'lowerLimit': '61.8', 'upperLimit': '80.1'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '59.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk12,PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2)', 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000', 'lowerLimit': '40.1', 'upperLimit': '56.2'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '87.1', 'upperLimit': '98.1'}, {'value': '92.6', 'groupId': 'OG002', 'lowerLimit': '83.7', 'upperLimit': '97.6'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '23.0', 'upperLimit': '77.0'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'EOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '74.9', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '78.0'}, {'value': '93.6', 'groupId': 'OG001', 'lowerLimit': '90.6', 'upperLimit': '95.9'}, {'value': '92.6', 'groupId': 'OG002', 'lowerLimit': '89.1', 'upperLimit': '95.3'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '56.6', 'upperLimit': '75.7'}, {'value': '85.7', 'groupId': 'OG004', 'lowerLimit': '42.1', 'upperLimit': '99.6'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'EOT, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2)', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000', 'lowerLimit': '48.2', 'upperLimit': '64.2'}, {'value': '92.0', 'groupId': 'OG001', 'lowerLimit': '84.1', 'upperLimit': '96.7'}, {'value': '89.7', 'groupId': 'OG002', 'lowerLimit': '79.9', 'upperLimit': '95.8'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}, {'title': '12wk PEOT, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000', 'lowerLimit': '47.4', 'upperLimit': '54.9'}, {'value': '81.4', 'groupId': 'OG001', 'lowerLimit': '77.0', 'upperLimit': '85.3'}, {'value': '71.9', 'groupId': 'OG002', 'lowerLimit': '66.4', 'upperLimit': '76.9'}, {'value': '44.1', 'groupId': 'OG003', 'lowerLimit': '34.3', 'upperLimit': '54.3'}, {'value': '57.1', 'groupId': 'OG004', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': '12wk PEOT, PEG-IFN alfa-2b (n=158,87,68,14,2,2)', 'categories': [{'measurements': [{'value': '39.9', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '48.0'}, {'value': '82.8', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '90.0'}, {'value': '70.6', 'groupId': 'OG002', 'lowerLimit': '58.3', 'upperLimit': '81.0'}, {'value': '35.7', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '64.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT', 'description': 'Modified virological response (mVR) is defined as HCV RNA \\<50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'PEG-IFN alfa-2a (n=778, 414, 353,114, 9, 2)', 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000', 'lowerLimit': '43.0', 'upperLimit': '50.1'}, {'value': '78.3', 'groupId': 'OG001', 'lowerLimit': '74.0', 'upperLimit': '82.1'}, {'value': '68.6', 'groupId': 'OG002', 'lowerLimit': '63.4', 'upperLimit': '73.4'}, {'value': '43.0', 'groupId': 'OG003', 'lowerLimit': '33.7', 'upperLimit': '52.6'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000', 'lowerLimit': '32.4', 'upperLimit': '47.1'}, {'value': '82.7', 'groupId': 'OG001', 'lowerLimit': '74.0', 'upperLimit': '89.4'}, {'value': '68.9', 'groupId': 'OG002', 'lowerLimit': '57.1', 'upperLimit': '79.2'}, {'value': '35.7', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '64.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'analyses': [{'pValue': '0.0211', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.527', 'ciLowerLimit': '0.306', 'ciUpperLimit': '0.908', 'groupDescription': 'The statistical analysis is presented for Gamma-Glutamyl Transferase (Gamma-GT) in log10 international units per liter (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \\[Wk\\]12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.078', 'ciLowerLimit': '1.065', 'ciUpperLimit': '1.092', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0053', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.220', 'ciLowerLimit': '1.061', 'ciUpperLimit': '1.403', 'groupDescription': 'The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0079', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.464', 'ciLowerLimit': '0.264', 'ciUpperLimit': '0.818', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\< 140 vs \\>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1808', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.737', 'ciLowerLimit': '0.471', 'ciUpperLimit': '1.153', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\>=140 - \\< 180 vs \\>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.082', 'ciLowerLimit': '1.069', 'ciUpperLimit': '1.095', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.676', 'ciLowerLimit': '0.542', 'ciUpperLimit': '0.844', 'groupDescription': 'The statistical analysis is presented for Weight per 10 kilogram (kg). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0041', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.573', 'ciLowerLimit': '0.392', 'ciUpperLimit': '0.838', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.094', 'ciLowerLimit': '1.048', 'ciUpperLimit': '1.142', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0031', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.945', 'ciLowerLimit': '2.013', 'ciUpperLimit': '31.359', 'groupDescription': 'The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0012', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.900', 'ciLowerLimit': '0.844', 'ciUpperLimit': '0.959', 'groupDescription': 'The statistical analysis is presented for body mass index (BMI) in kilogram per square meter (kg/m\\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0085', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.619', 'ciLowerLimit': '0.433', 'ciUpperLimit': '0.885', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.130', 'ciLowerLimit': '1.087', 'ciUpperLimit': '1.174', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0341', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.784', 'ciLowerLimit': '0.626', 'ciUpperLimit': '0.982', 'groupDescription': 'The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0443', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.575', 'ciLowerLimit': '0.335', 'ciUpperLimit': '0.986', 'groupDescription': 'The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\\> 1.5 vs \\<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.100', 'ciLowerLimit': '1.057', 'ciUpperLimit': '1.144', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0039', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.867', 'ciLowerLimit': '2.730', 'ciUpperLimit': '191.56', 'groupDescription': 'The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0244', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.780', 'ciLowerLimit': '0.628', 'ciUpperLimit': '0.968', 'groupDescription': 'The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.128', 'ciLowerLimit': '1.086', 'ciUpperLimit': '1.172', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0453', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.547', 'ciLowerLimit': '0.303', 'ciUpperLimit': '0.987', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0184', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.133', 'ciLowerLimit': '0.025', 'ciUpperLimit': '0.712', 'groupDescription': 'The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.103', 'ciLowerLimit': '1.072', 'ciUpperLimit': '1.134', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in Weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0019', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.543', 'ciLowerLimit': '0.370', 'ciUpperLimit': '0.798', 'groupDescription': 'The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0017', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.359', 'ciLowerLimit': '0.189', 'ciUpperLimit': '0.679', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.080', 'ciLowerLimit': '1.047', 'ciUpperLimit': '1.114', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0042', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.093', 'ciLowerLimit': '1.029', 'ciUpperLimit': '1.162', 'groupDescription': 'The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0168', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.535', 'ciLowerLimit': '0.320', 'ciUpperLimit': '0.893', 'groupDescription': 'The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0128', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.501', 'ciLowerLimit': '0.291', 'ciUpperLimit': '0.864', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\< 140 vs \\>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4634', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.853', 'ciLowerLimit': '0.558', 'ciUpperLimit': '1.305', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\>=140 - \\< 180 vs \\>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.655', 'ciLowerLimit': '9.725', 'ciUpperLimit': '39.722', 'groupDescription': 'The statistical analysis is presented for On-treatment response (Rapid Virological Response \\[RVR\\] vs No RVR/EVR \\[Early Virological Response\\]). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.569', 'ciLowerLimit': '4.408', 'ciUpperLimit': '16.658', 'groupDescription': 'The statistical analysis is presented for on-treatment response (cEVR \\[Complete Early Virological Response\\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0089', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.519', 'ciLowerLimit': '1.260', 'ciUpperLimit': '5.034', 'groupDescription': 'The statistical analysis is presented for on-treatment response (pEVR \\[Partial Early Virological Response\\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0037', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.908', 'ciLowerLimit': '0.851', 'ciUpperLimit': '0.969', 'groupDescription': 'The statistical analysis is presented for BMI in kg/m\\^2. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0020', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.553', 'ciLowerLimit': '0.379', 'ciUpperLimit': '0.805', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.537', 'ciLowerLimit': '3.654', 'ciUpperLimit': '74.849', 'groupDescription': 'The statistical analysis is presented for On-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0733', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.386', 'ciLowerLimit': '0.870', 'ciUpperLimit': '22.114', 'groupDescription': 'The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3478', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.352', 'ciLowerLimit': '0.394', 'ciUpperLimit': '14.031', 'groupDescription': 'The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0264', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.729', 'ciLowerLimit': '0.552', 'ciUpperLimit': '0.964', 'groupDescription': 'The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0096', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.658', 'ciLowerLimit': '1.586', 'ciUpperLimit': '27.946', 'groupDescription': 'The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0421', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.734', 'ciLowerLimit': '1.057', 'ciUpperLimit': '21.203', 'groupDescription': 'The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6004', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.602', 'ciLowerLimit': '0.090', 'ciUpperLimit': '4.014', 'groupDescription': 'The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0418', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.715', 'ciLowerLimit': '0.517', 'ciUpperLimit': '0.988', 'groupDescription': 'The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0279', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.198', 'ciLowerLimit': '0.047', 'ciUpperLimit': '0.839', 'groupDescription': 'The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.880', 'ciLowerLimit': '7.474', 'ciUpperLimit': '223.61', 'groupDescription': 'The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.395', 'ciLowerLimit': '8.724', 'ciUpperLimit': '206.02', 'groupDescription': 'The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0087', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.247', 'ciLowerLimit': '1.704', 'ciUpperLimit': '39.908', 'groupDescription': 'The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA \\<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'PEG-IFN alfa-2a (n=704, 361, 299, 102, 7, 2)', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '43.8', 'upperLimit': '51.3'}, {'value': '79.5', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '83.5'}, {'value': '69.2', 'groupId': 'OG002', 'lowerLimit': '63.7', 'upperLimit': '74.4'}, {'value': '40.2', 'groupId': 'OG003', 'lowerLimit': '30.6', 'upperLimit': '50.4'}, {'value': '57.1', 'groupId': 'OG004', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000', 'lowerLimit': '31.6', 'upperLimit': '47.3'}, {'value': '81.6', 'groupId': 'OG001', 'lowerLimit': '71.9', 'upperLimit': '89.1'}, {'value': '69.1', 'groupId': 'OG002', 'lowerLimit': '56.7', 'upperLimit': '79.8'}, {'value': '35.7', 'groupId': 'OG003', 'lowerLimit': '12.8', 'upperLimit': '64.9'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Modified sustained virological response is defined as mVR of HCV RNA \\<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '17.1'}, {'value': '33.8', 'groupId': 'OG001', 'lowerLimit': '29.3', 'upperLimit': '38.6'}, {'value': '20.1', 'groupId': 'OG002', 'lowerLimit': '16.1', 'upperLimit': '24.7'}, {'value': '5.3', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '11.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '15.8'}, {'value': '24.0', 'groupId': 'OG001', 'lowerLimit': '16.2', 'upperLimit': '33.4'}, {'value': '20.3', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '31.2'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '42.8'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '55.4', 'upperLimit': '62.5'}, {'value': '90.8', 'groupId': 'OG001', 'lowerLimit': '87.6', 'upperLimit': '93.4'}, {'value': '85.0', 'groupId': 'OG002', 'lowerLimit': '80.8', 'upperLimit': '88.5'}, {'value': '64.0', 'groupId': 'OG003', 'lowerLimit': '54.5', 'upperLimit': '72.8'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '38.8', 'upperLimit': '53.7'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '87.9', 'upperLimit': '97.9'}, {'value': '85.1', 'groupId': 'OG002', 'lowerLimit': '75.0', 'upperLimit': '92.3'}, {'value': '42.9', 'groupId': 'OG003', 'lowerLimit': '17.7', 'upperLimit': '71.1'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '83.4', 'groupId': 'OG000', 'lowerLimit': '80.6', 'upperLimit': '86.0'}, {'value': '96.1', 'groupId': 'OG001', 'lowerLimit': '93.8', 'upperLimit': '97.8'}, {'value': '96.0', 'groupId': 'OG002', 'lowerLimit': '93.4', 'upperLimit': '97.8'}, {'value': '77.2', 'groupId': 'OG003', 'lowerLimit': '68.4', 'upperLimit': '84.5'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '66.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '79.4'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '94.8', 'upperLimit': '100.0'}, {'value': '97.3', 'groupId': 'OG002', 'lowerLimit': '90.6', 'upperLimit': '99.7'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2, Week 4 and Week 12', 'description': 'Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values \\<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '17.3'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '31.1', 'upperLimit': '41.2'}, {'value': '20.4', 'groupId': 'OG002', 'lowerLimit': '16.0', 'upperLimit': '25.4'}, {'value': '4.9', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '11.1'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '41.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '15.9'}, {'value': '26.4', 'groupId': 'OG001', 'lowerLimit': '17.6', 'upperLimit': '37.0'}, {'value': '22.1', 'groupId': 'OG002', 'lowerLimit': '12.9', 'upperLimit': '33.8'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '42.8'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000', 'lowerLimit': '56.2', 'upperLimit': '63.6'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '89.3', 'upperLimit': '95.0'}, {'value': '84.9', 'groupId': 'OG002', 'lowerLimit': '80.4', 'upperLimit': '88.8'}, {'value': '65.7', 'groupId': 'OG003', 'lowerLimit': '55.6', 'upperLimit': '74.8'}, {'value': '57.1', 'groupId': 'OG004', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000', 'lowerLimit': '37.6', 'upperLimit': '53.7'}, {'value': '95.4', 'groupId': 'OG001', 'lowerLimit': '88.6', 'upperLimit': '98.7'}, {'value': '83.8', 'groupId': 'OG002', 'lowerLimit': '72.9', 'upperLimit': '91.6'}, {'value': '42.9', 'groupId': 'OG003', 'lowerLimit': '17.7', 'upperLimit': '71.1'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000', 'lowerLimit': '81.9', 'upperLimit': '87.4'}, {'value': '96.7', 'groupId': 'OG001', 'lowerLimit': '94.3', 'upperLimit': '98.3'}, {'value': '96.7', 'groupId': 'OG002', 'lowerLimit': '93.9', 'upperLimit': '98.4'}, {'value': '78.4', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '86.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '59.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk12,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000', 'lowerLimit': '65.8', 'upperLimit': '80.1'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '93.8', 'upperLimit': '100.0'}, {'value': '97.1', 'groupId': 'OG002', 'lowerLimit': '89.8', 'upperLimit': '99.6'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2, Week 4 and Week 12', 'description': 'Participants with 2-log drop in HCV RNA including HCV RNA values \\<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk2, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '26.8'}, {'value': '37.2', 'groupId': 'OG001', 'lowerLimit': '32.5', 'upperLimit': '42.1'}, {'value': '21.8', 'groupId': 'OG002', 'lowerLimit': '17.6', 'upperLimit': '26.5'}, {'value': '8.8', 'groupId': 'OG003', 'lowerLimit': '4.3', 'upperLimit': '15.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '13.3', 'upperLimit': '25.1'}, {'value': '26.9', 'groupId': 'OG001', 'lowerLimit': '18.7', 'upperLimit': '36.5'}, {'value': '24.3', 'groupId': 'OG002', 'lowerLimit': '15.1', 'upperLimit': '35.7'}, {'value': '21.4', 'groupId': 'OG003', 'lowerLimit': '4.7', 'upperLimit': '50.8'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '76.6', 'upperLimit': '82.3'}, {'value': '93.0', 'groupId': 'OG001', 'lowerLimit': '90.1', 'upperLimit': '95.3'}, {'value': '87.8', 'groupId': 'OG002', 'lowerLimit': '83.9', 'upperLimit': '91.0'}, {'value': '78.1', 'groupId': 'OG003', 'lowerLimit': '69.4', 'upperLimit': '85.3'}, {'value': '88.9', 'groupId': 'OG004', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '68.9', 'upperLimit': '81.9'}, {'value': '96.2', 'groupId': 'OG001', 'lowerLimit': '90.4', 'upperLimit': '98.9'}, {'value': '89.2', 'groupId': 'OG002', 'lowerLimit': '79.8', 'upperLimit': '95.2'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '93.6', 'groupId': 'OG000', 'lowerLimit': '91.6', 'upperLimit': '95.2'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.2'}, {'value': '97.2', 'groupId': 'OG002', 'lowerLimit': '94.9', 'upperLimit': '98.6'}, {'value': '86.0', 'groupId': 'OG003', 'lowerLimit': '78.2', 'upperLimit': '91.8'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '66.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000', 'lowerLimit': '83.5', 'upperLimit': '93.2'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '94.8', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '92.7', 'upperLimit': '100.0'}, {'value': '78.6', 'groupId': 'OG003', 'lowerLimit': '49.2', 'upperLimit': '95.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2, Week 4 and Week 12', 'description': 'Participants with 1-log drop in HCV RNA including HCV RNA values \\<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk4,PEG-IFN alfa-2a, PPV (n=733,397,325,104,8,2)', 'categories': [{'measurements': [{'value': '74.9', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '80.7'}, {'value': '84.7', 'groupId': 'OG001', 'lowerLimit': '80.4', 'upperLimit': '88.4'}, {'value': '74.8', 'groupId': 'OG002', 'lowerLimit': '68.9', 'upperLimit': '80.1'}, {'value': '64.3', 'groupId': 'OG003', 'lowerLimit': '48.0', 'upperLimit': '78.4'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '39.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2a, NPV (n=733,397,325,104,8,2)', 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000', 'lowerLimit': '59.8', 'upperLimit': '68.1'}, {'value': '51.6', 'groupId': 'OG001', 'lowerLimit': '38.7', 'upperLimit': '64.2'}, {'value': '52.0', 'groupId': 'OG002', 'lowerLimit': '40.2', 'upperLimit': '63.7'}, {'value': '71.0', 'groupId': 'OG003', 'lowerLimit': '58.1', 'upperLimit': '81.8'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b, PPV (n=177,101,71,14,2,2)', 'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000', 'lowerLimit': '52.8', 'upperLimit': '87.3'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '82.4', 'upperLimit': '96.3'}, {'value': '80.0', 'groupId': 'OG002', 'lowerLimit': '66.3', 'upperLimit': '90.0'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '22.3', 'upperLimit': '95.7'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b, NPV (n=177,101,71,14,2,2)', 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '59.4', 'upperLimit': '75.0'}, {'value': '47.8', 'groupId': 'OG001', 'lowerLimit': '26.8', 'upperLimit': '69.4'}, {'value': '61.9', 'groupId': 'OG002', 'lowerLimit': '38.4', 'upperLimit': '81.9'}, {'value': '87.5', 'groupId': 'OG003', 'lowerLimit': '47.3', 'upperLimit': '99.7'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}, {'title': 'Wk12,PEG-IFN alfa-2a,PPV (n=768,412,350,109,9,2)', 'categories': [{'measurements': [{'value': '64.6', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '68.9'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '77.6', 'upperLimit': '85.6'}, {'value': '72.4', 'groupId': 'OG002', 'lowerLimit': '67.2', 'upperLimit': '77.2'}, {'value': '59.2', 'groupId': 'OG003', 'lowerLimit': '47.3', 'upperLimit': '70.4'}, {'value': '75.0', 'groupId': 'OG004', 'lowerLimit': '34.9', 'upperLimit': '96.8'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}, {'title': 'Wk12,PEG-IFN alfa-2a, NPV(n=768,412,350,109,9,2)', 'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000', 'lowerLimit': '75.2', 'upperLimit': '84.4'}, {'value': '59.4', 'groupId': 'OG001', 'lowerLimit': '40.6', 'upperLimit': '76.3'}, {'value': '74.1', 'groupId': 'OG002', 'lowerLimit': '53.7', 'upperLimit': '88.9'}, {'value': '93.9', 'groupId': 'OG003', 'lowerLimit': '79.8', 'upperLimit': '99.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk12,PEG-IFN alfa-2b, PPV (n=181, 104,74,14,2,2)', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000', 'lowerLimit': '57.3', 'upperLimit': '78.9'}, {'value': '86.3', 'groupId': 'OG001', 'lowerLimit': '77.7', 'upperLimit': '92.5'}, {'value': '73.8', 'groupId': 'OG002', 'lowerLimit': '61.5', 'upperLimit': '84.0'}, {'value': '71.4', 'groupId': 'OG003', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2b, NPV (n=181, 104,74,14,2,2)', 'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '88.6'}, {'value': '55.6', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '86.3'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '59.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT', 'description': 'The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk4,PEG-IFN alfa-2a, PPV (n=668,351,275,93,6,2)', 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '69.0', 'upperLimit': '81.8'}, {'value': '85.6', 'groupId': 'OG001', 'lowerLimit': '81.1', 'upperLimit': '89.4'}, {'value': '73.7', 'groupId': 'OG002', 'lowerLimit': '67.3', 'upperLimit': '79.5'}, {'value': '61.5', 'groupId': 'OG003', 'lowerLimit': '44.6', 'upperLimit': '76.6'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}, {'title': 'Wk4,PEG-IFN alfa-2a, NPV (n=668,351,275,93,6,2)', 'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': '67.8'}, {'value': '49.1', 'groupId': 'OG001', 'lowerLimit': '35.1', 'upperLimit': '63.2'}, {'value': '45.2', 'groupId': 'OG002', 'lowerLimit': '32.5', 'upperLimit': '58.3'}, {'value': '74.1', 'groupId': 'OG003', 'lowerLimit': '60.3', 'upperLimit': '85.0'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b, PPV (n=155,85,65,14,2,2)', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '53.3', 'upperLimit': '90.2'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '81.3', 'upperLimit': '96.6'}, {'value': '81.8', 'groupId': 'OG002', 'lowerLimit': '67.3', 'upperLimit': '91.8'}, {'value': '66.7', 'groupId': 'OG003', 'lowerLimit': '22.3', 'upperLimit': '95.7'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b, NPV (n=155,85,65,14,2,2)', 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '76.5'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '28.9', 'upperLimit': '75.6'}, {'value': '61.9', 'groupId': 'OG002', 'lowerLimit': '38.4', 'upperLimit': '81.9'}, {'value': '87.5', 'groupId': 'OG003', 'lowerLimit': '47.3', 'upperLimit': '99.7'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}, {'title': 'Wk12,PEG-IFN alfa-2a, PPV(n=697,359,296,98,7,2)', 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '60.4', 'upperLimit': '69.7'}, {'value': '82.4', 'groupId': 'OG001', 'lowerLimit': '77.9', 'upperLimit': '86.4'}, {'value': '72.5', 'groupId': 'OG002', 'lowerLimit': '66.8', 'upperLimit': '77.6'}, {'value': '55.7', 'groupId': 'OG003', 'lowerLimit': '43.3', 'upperLimit': '67.6'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '22.3', 'upperLimit': '95.7'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}, {'title': 'Wk12,PEG-IFN alfa-2a, NPV (n=697,359,296,98,7,2)', 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '84.2'}, {'value': '56.5', 'groupId': 'OG001', 'lowerLimit': '34.5', 'upperLimit': '76.8'}, {'value': '70.0', 'groupId': 'OG002', 'lowerLimit': '45.7', 'upperLimit': '88.1'}, {'value': '96.4', 'groupId': 'OG003', 'lowerLimit': '81.7', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2b, PPV (n=158, 87,68,14,2,2)', 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000', 'lowerLimit': '56.2', 'upperLimit': '79.4'}, {'value': '85.0', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '92.0'}, {'value': '74.6', 'groupId': 'OG002', 'lowerLimit': '61.6', 'upperLimit': '85.0'}, {'value': '71.4', 'groupId': 'OG003', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2b, NPV (n=158, 87,68,14,2,2)', 'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '89.6'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '59.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT', 'description': 'The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk2, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '27.3'}, {'value': '39.9', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '45.1'}, {'value': '22.4', 'groupId': 'OG002', 'lowerLimit': '17.8', 'upperLimit': '27.6'}, {'value': '7.8', 'groupId': 'OG003', 'lowerLimit': '3.4', 'upperLimit': '14.9'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '41.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk2,PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '23.9'}, {'value': '28.7', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '39.4'}, {'value': '26.5', 'groupId': 'OG002', 'lowerLimit': '16.5', 'upperLimit': '38.6'}, {'value': '21.4', 'groupId': 'OG003', 'lowerLimit': '4.7', 'upperLimit': '50.8'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '98.7'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2a (n=704,361,299,102,7, 2)', 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000', 'lowerLimit': '78.2', 'upperLimit': '84.1'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '91.9', 'upperLimit': '96.8'}, {'value': '88.3', 'groupId': 'OG002', 'lowerLimit': '84.1', 'upperLimit': '91.7'}, {'value': '79.4', 'groupId': 'OG003', 'lowerLimit': '70.3', 'upperLimit': '86.8'}, {'value': '85.7', 'groupId': 'OG004', 'lowerLimit': '42.1', 'upperLimit': '99.6'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk4, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '82.9'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '99.3'}, {'value': '88.2', 'groupId': 'OG002', 'lowerLimit': '78.1', 'upperLimit': '94.8'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '28.9', 'upperLimit': '82.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': '96.4'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '96.4', 'upperLimit': '99.4'}, {'value': '98.0', 'groupId': 'OG002', 'lowerLimit': '95.7', 'upperLimit': '99.3'}, {'value': '87.3', 'groupId': 'OG003', 'lowerLimit': '79.2', 'upperLimit': '93.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '59.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}, {'title': 'Wk12, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '84.8', 'upperLimit': '94.6'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '93.8', 'upperLimit': '100.0'}, {'value': '98.5', 'groupId': 'OG002', 'lowerLimit': '92.1', 'upperLimit': '100.0'}, {'value': '78.6', 'groupId': 'OG003', 'lowerLimit': '49.2', 'upperLimit': '95.3'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '15.8', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2, Week 4 and Week 12', 'description': 'Participants with 1-log drop in HCV RNA including HCV RNA values \\<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk2, PEG-IFN alfa-2a, PPV (n=267,174,98,16,0, 1)', 'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000', 'lowerLimit': '67.2', 'upperLimit': '94.7'}, {'value': '92.2', 'groupId': 'OG001', 'lowerLimit': '84.6', 'upperLimit': '96.8'}, {'value': '77.1', 'groupId': 'OG002', 'lowerLimit': '59.9', 'upperLimit': '89.6'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': 'NA', 'comment': 'Predictive values could not be determined as the denominator was zero.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Predictive values could not be determined as the denominator was zero.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2a,NPV (n=267, 174,98,16, 0, 1)', 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '58.5'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '14.2', 'upperLimit': '33.0'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '17.9', 'upperLimit': '41.3'}, {'value': '69.2', 'groupId': 'OG003', 'lowerLimit': '38.6', 'upperLimit': '90.9'}, {'value': 'NA', 'comment': 'Predictive values could not be determined as the denominator was zero.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b, PPV (n=54, 29, 19,7,1,1)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '14.7', 'upperLimit': '94.7'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b, NPV (n=54,29,19,7,1, 1)', 'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000', 'lowerLimit': '44.3', 'upperLimit': '73.6'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '58.1'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '11.8', 'upperLimit': '88.2'}, {'value': 'NA', 'comment': 'Predictive values could not be determined as the denominator was zero.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Predictive values could not be determined as the denominator was zero.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after EOT', 'description': 'The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'Wk2, PEG-IFN alfa-2a, PPV (n=246, 63,87,14,0,1)', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '93.9'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '85.1', 'upperLimit': '97.3'}, {'value': '74.2', 'groupId': 'OG002', 'lowerLimit': '55.4', 'upperLimit': '88.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': 'NA', 'comment': 'Predictive values could not be determined as the denominator was zero.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Predictive values could not be determined as the denominator was zero.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2a, NPV (n=246, 163,87,14,0,1)', 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '58.6'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '32.2'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '17.3', 'upperLimit': '42.2'}, {'value': '75.0', 'groupId': 'OG003', 'lowerLimit': '42.8', 'upperLimit': '94.5'}, {'value': 'NA', 'comment': 'Predictive values could not be determined as the denominator was zero.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b, PPV (n=43, 26,19,7,1,1)', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '96.3'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '14.7', 'upperLimit': '94.7'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Wk2, PEG-IFN alfa-2b, NPV (n=43, 26,19,7,1,1)', 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000', 'lowerLimit': '38.3', 'upperLimit': '71.4'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '39.6'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '58.1'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '11.8', 'upperLimit': '88.2'}, {'value': 'NA', 'comment': 'Predictive values could not be determined as the denominator was zero.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Predictive values could not be determined as the denominator was zero.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after EOT', 'description': 'The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'RVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'RVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'mRVR,PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}, {'value': '354', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'mRVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'cEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'cEVR, PEG-IFN alfa-2b (n=182, 104, 74,14, 2, 2)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'mcEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'mCEVR, PEG-IFN alfa-2b (n=182,104,74,14,2, 2)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'pEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'pEVR, PEG-IFN alfa-2b (n=182, 104,74,14, 2, 2)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'mpEVR, PEG-IFN alfa-2a (n=778,414,353,114,9,2)', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'mpEVR, PEG-IFN alfa-2b (n=182,104, 74,14,2, 2)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4 and Week 12', 'description': 'Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values \\<50 IU/mL) by, Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': 'RVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '213', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'RVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'mRVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'mRVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'cEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'cEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'mcEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'mCEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'pEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'pEVR, PEG-IFN alfa-2b (n=158, 87, 68, 14, 2, 2)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'mpEVR, PEG-IFN alfa-2a (n=704,361,299,102,7,2)', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'mpEVR, PEG-IFN alfa-2b (n=158, 87, 68,14, 2, 2)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4 and Week 12', 'description': 'RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values \\<50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': '12wk PEOT, PEG-IFN alfa-2a (n=257,193,109,14,0,0)', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}, {'value': '14.7', 'groupId': 'OG002'}, {'value': '21.4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '12wk PEOT, PEG-IFN alfa-2b (n=36,50,27,3,0,0)', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}, {'value': '7.4', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 weeks after EOT', 'description': 'Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV inclusive of all Genotypes who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': '12Wk PEOT, PEG-IFN alfa-2a (n=239,175,98,12,0,0)', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '12wk PEOT, PEG-IFN alfa-2b (n=28,43,25,3,0,0)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '4.7', 'groupId': 'OG001'}, {'value': '8.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 weeks after EOT', 'description': 'Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '960', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '427', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': '24Wk PEOT, PEG-IFN alfa-2a (n=508,364,282,69,8,2)', 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}, {'value': '14.2', 'groupId': 'OG002'}, {'value': '29.0', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '24wk PEOT, PEG-IFN alfa-2b (n=91,93,57,7,2,0)', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}, {'value': '10.5', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '15.0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.957', 'ciLowerLimit': '1.383', 'ciUpperLimit': '2.770', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0007', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.337', 'ciLowerLimit': '1.661', 'ciUpperLimit': '6.705', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\< 140 vs \\>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3611', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.305', 'ciLowerLimit': '0.737', 'ciUpperLimit': '2.312', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\>=140 - \\< 180 vs \\>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.943', 'ciLowerLimit': '0.929', 'ciUpperLimit': '0.958', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0020', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.743', 'ciLowerLimit': '0.615', 'ciUpperLimit': '0.897', 'groupDescription': 'The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.864', 'ciLowerLimit': '1.322', 'ciUpperLimit': '2.628', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0386', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.124', 'ciLowerLimit': '1.040', 'ciUpperLimit': '4.338', 'groupDescription': 'The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.398', 'ciLowerLimit': '1.722', 'ciUpperLimit': '6.706', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\< 140 vs \\>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2769', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.372', 'ciLowerLimit': '0.776', 'ciUpperLimit': '2.428', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\>=140 - \\< 180 vs \\>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.945', 'ciLowerLimit': '0.931', 'ciUpperLimit': '0.960', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.163', 'ciLowerLimit': '1.078', 'ciUpperLimit': '1.256', 'groupDescription': 'The statistical analysis is presented for BMI in kg/m\\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0213', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.788', 'ciLowerLimit': '1.091', 'ciUpperLimit': '2.932', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.903', 'ciLowerLimit': '0.856', 'ciUpperLimit': '0.953', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0306', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.723', 'ciLowerLimit': '0.538', 'ciUpperLimit': '0.970', 'groupDescription': 'The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0005', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.145', 'ciLowerLimit': '1.061', 'ciUpperLimit': '1.236', 'groupDescription': 'The statistical analysis is presented for BMI in kg/m\\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0122', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.907', 'ciLowerLimit': '1.151', 'ciUpperLimit': '3.158', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0956', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.175', 'ciLowerLimit': '0.872', 'ciUpperLimit': '5.424', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\< 140 vs \\>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0846', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.267', 'ciLowerLimit': '0.060', 'ciUpperLimit': '1.197', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\>=140 - \\< 180 vs \\>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.897', 'ciLowerLimit': '0.852', 'ciUpperLimit': '0.945', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0033', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.996', 'ciLowerLimit': '1.259', 'ciUpperLimit': '3.165', 'groupDescription': 'The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0095', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.150', 'ciLowerLimit': '1.035', 'ciUpperLimit': '1.277', 'groupDescription': 'The statistical analysis is presented for BMI in kg/m\\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0031', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.155', 'ciLowerLimit': '0.045', 'ciUpperLimit': '0.533', 'groupDescription': 'The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0645', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.364', 'ciLowerLimit': '0.125', 'ciUpperLimit': '1.063', 'groupDescription': 'The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.895', 'ciLowerLimit': '0.846', 'ciUpperLimit': '0.948', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0033', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.996', 'ciLowerLimit': '1.259', 'ciUpperLimit': '3.165', 'groupDescription': 'The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0095', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.150', 'ciLowerLimit': '1.035', 'ciUpperLimit': '1.277', 'groupDescription': 'The statistical analysis is presented for BMI in kg/m\\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0031', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.155', 'ciLowerLimit': '0.045', 'ciUpperLimit': '0.533', 'groupDescription': 'The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0645', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.364', 'ciLowerLimit': '0.125', 'ciUpperLimit': '1.063', 'groupDescription': 'The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.895', 'ciLowerLimit': '0.846', 'ciUpperLimit': '0.948', 'groupDescription': 'The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0182', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.266', 'ciLowerLimit': '1.041', 'ciUpperLimit': '1.541', 'groupDescription': 'The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0092', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.590', 'ciLowerLimit': '1.122', 'ciUpperLimit': '2.254', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0020', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.974', 'ciLowerLimit': '1.488', 'ciUpperLimit': '5.942', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\< 140 vs \\>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6524', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.142', 'ciLowerLimit': '0.641', 'ciUpperLimit': '2.035', 'groupDescription': 'The statistical analysis is presented for Platelets x 10\\*\\*9/L at BL (\\>=140 - \\< 180 vs \\>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.108', 'ciLowerLimit': '0.037', 'ciUpperLimit': '0.311', 'groupDescription': 'The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0429', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.389', 'ciLowerLimit': '0.156', 'ciUpperLimit': '0.970', 'groupDescription': 'The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5490', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.330', 'ciLowerLimit': '0.523', 'ciUpperLimit': '3.380', 'groupDescription': 'The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0008', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.136', 'ciLowerLimit': '1.054', 'ciUpperLimit': '1.224', 'groupDescription': 'The statistical analysis is presented for BMI in kg/m\\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0140', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.855', 'ciLowerLimit': '1.133', 'ciUpperLimit': '3.037', 'groupDescription': 'The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0575', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.126', 'ciLowerLimit': '0.015', 'ciUpperLimit': '1.068', 'groupDescription': 'The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7128', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.660', 'ciLowerLimit': '0.072', 'ciUpperLimit': '6.025', 'groupDescription': 'The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5960', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.505', 'ciLowerLimit': '0.040', 'ciUpperLimit': '6.318', 'groupDescription': 'The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0033', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.051', 'ciLowerLimit': '1.270', 'ciUpperLimit': '3.311', 'groupDescription': 'The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0452', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.113', 'ciLowerLimit': '1.002', 'ciUpperLimit': '1.236', 'groupDescription': 'The statistical analysis is presented for BMI in kg/m\\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0040', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.154', 'ciLowerLimit': '0.043', 'ciUpperLimit': '0.551', 'groupDescription': 'The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0833', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.393', 'ciLowerLimit': '0.137', 'ciUpperLimit': '1.131', 'groupDescription': 'The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1439', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.141', 'ciLowerLimit': '0.010', 'ciUpperLimit': '1.951', 'groupDescription': 'The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4457', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.350', 'ciLowerLimit': '0.024', 'ciUpperLimit': '5.194', 'groupDescription': 'The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6258', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.142', 'ciLowerLimit': '0.100', 'ciUpperLimit': '45.801', 'groupDescription': 'The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result \\<50 IU/mL were excluded. n = the number of participants analyzed at a given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '862', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'OG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'classes': [{'title': '24Wk PEOT, PEG-IFN alfa-2a (n=468,323,240,60,6,2)', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}, {'value': '13.8', 'groupId': 'OG002'}, {'value': '31.7', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '24wk PEOT, PEG-IFN alfa-2b (n=79,77,53,7,2,0)', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}, {'value': '11.3', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received Pegasys® (Pegylated Interferon \\[PEG-IFN\\] alfa-2a) or PegIntron® (PEG-IFN alfa-2b) plus ribavirin dose according to the standard of care and in line with summary of product characteristics (SPCs)/local labeling for up to 72 weeks were observed.'}, {'id': 'FG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'FG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'FG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'FG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'FG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1128'}, {'groupId': 'FG001', 'numSubjects': '572'}, {'groupId': 'FG002', 'numSubjects': '484'}, {'groupId': 'FG003', 'numSubjects': '143'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '754'}, {'groupId': 'FG001', 'numSubjects': '495'}, {'groupId': 'FG002', 'numSubjects': '369'}, {'groupId': 'FG003', 'numSubjects': '94'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '374'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '115'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '82'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Early Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lab test not done', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Non-responders', 'reasons': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Result Not Available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Treatment Interrupted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Treatment Never Started', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Treatment Stopped', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 2343 participants were enrolled in this study conducted from October 2007 to May 2011 at 125 centers in Belgium, Italy, United Kingdom, and Ireland.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1128', 'groupId': 'BG000'}, {'value': '572', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '2343', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Genotype 1 (G1)', 'description': 'Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'BG001', 'title': 'Genotype 2 (G2)', 'description': 'Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'BG002', 'title': 'Genotype 3 (G3)', 'description': 'Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'BG003', 'title': 'Genotype 4 (G4)', 'description': 'Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'BG004', 'title': 'Genotype 5/6 (G5/6)', 'description': 'Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'BG005', 'title': 'Unknown Genotype (UNK)', 'description': 'Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '12.52', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '12.52', 'groupId': 'BG001'}, {'value': '40.6', 'spread': '9.20', 'groupId': 'BG002'}, {'value': '46.6', 'spread': '11.56', 'groupId': 'BG003'}, {'value': '52.7', 'spread': '12.82', 'groupId': 'BG004'}, {'value': '51.4', 'spread': '13.24', 'groupId': 'BG005'}, {'value': '48.5', 'spread': '12.71', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '532', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1017', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '596', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1326', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The all patient enrolled population included every participant for whom there was any data available in the PROPHESYS database.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2343}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-04', 'studyFirstSubmitDate': '2010-02-09', 'resultsFirstSubmitDate': '2016-04-04', 'studyFirstSubmitQcDate': '2010-02-09', 'lastUpdatePostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-04', 'studyFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of \\<15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection \\[LLOD\\] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}, {'measure': 'Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of \\<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}, {'measure': 'Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA \\<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}, {'measure': 'Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Modified sustained virological response is defined as mVR of HCV RNA \\<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}, {'measure': 'Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population', 'timeFrame': 'At 24 weeks after EOT', 'description': 'The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}, {'measure': 'Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population', 'timeFrame': 'At 24 weeks after EOT', 'description': 'The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time', 'timeFrame': 'At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT', 'description': 'Virological response (VR) was defined as HCV RNA \\<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment'}, {'measure': 'Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time', 'timeFrame': 'At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT', 'description': 'Virological response (VR) was defined as HCV RNA \\<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment'}, {'measure': 'Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time', 'timeFrame': 'At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT', 'description': 'Modified virological response (mVR) was defined as HCV RNA \\<50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment'}, {'measure': 'Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time', 'timeFrame': 'At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT', 'description': 'Modified virological response (mVR) is defined as HCV RNA \\<50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment'}, {'measure': 'Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12', 'timeFrame': 'At Week 2, Week 4 and Week 12', 'description': 'Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values \\<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.'}, {'measure': 'Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12', 'timeFrame': 'At Week 2, Week 4 and Week 12', 'description': 'Participants with 2-log drop in HCV RNA including HCV RNA values \\<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.'}, {'measure': 'Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12', 'timeFrame': 'At Week 2, Week 4 and Week 12', 'description': 'Participants with 1-log drop in HCV RNA including HCV RNA values \\<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.'}, {'measure': 'Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12', 'timeFrame': 'At Week 2, Week 4 and Week 12', 'description': 'Participants with 1-log drop in HCV RNA including HCV RNA values \\<50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.'}, {'measure': 'Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population', 'timeFrame': '24 weeks after EOT', 'description': 'The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}, {'measure': 'Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population', 'timeFrame': '24 weeks after EOT', 'description': 'The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}, {'measure': 'Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12', 'timeFrame': 'At Week 4 and Week 12', 'description': 'Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values \\<50 IU/mL) by, Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.'}, {'measure': 'Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12', 'timeFrame': 'At Week 4 and Week 12', 'description': 'RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values \\<50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.'}, {'measure': 'Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment', 'timeFrame': 'At 12 weeks after EOT', 'description': 'Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}, {'measure': 'Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment', 'timeFrame': 'At 12 weeks after EOT', 'description': 'Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}, {'measure': 'Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}, {'measure': 'Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment', 'timeFrame': 'At 24 weeks after EOT', 'description': 'Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '26158171', 'type': 'DERIVED', 'citation': 'Ascione A, Bruno S, Coppola C, Mangia A, Orlandini A, Schmitz M, Deodato B, Puoti M. Treatment Outcomes and Predictors of Response in Treatment-Naive HCV Patients Treated with Peginterferon Alfa/Ribavirin in Real-World Italian Clinics: Sub-Analysis from the PROPHESYS Cohort. Hepatogastroenterology. 2014 Jun;61(132):1094-106.'}, {'pmid': '24329937', 'type': 'DERIVED', 'citation': 'Ferenci P, Aires R, Ancuta I, Arohnson A, Cheinquer H, Delic D, Gschwantler M, Larrey D, Tallarico L, Schmitz M, Tatsch F, Ouzan D. A tool for selecting patients with a high probability of sustained virological response to peginterferon alfa-2a (40kD)/ribavirin. Liver Int. 2014 Nov;34(10):1550-9. doi: 10.1111/liv.12439. Epub 2014 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is \\<2000.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving peginterferon alfa treatment at a medical centre', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>/= 18 years of age\n* chronic hepatitis C\n* informed consent to data collection\n\nExclusion Criteria:\n\n* co-infection with HIV or HBV\n* previous treatment with peginterferon and/or ribavirin'}, 'identificationModule': {'nctId': 'NCT01066793', 'briefTitle': 'PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons.', 'orgStudyIdInfo': {'id': 'MV21020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort', 'description': 'Participants chronically infected with the hepatitis C virus including genotypes 1 to 6', 'interventionNames': ['Drug: Peginterferon alfa-2a [Pegasys]', 'Drug: Peginterferon alfa-2b [PegIntron®]']}], 'interventions': [{'name': 'Peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': 'Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.', 'armGroupLabels': ['Cohort']}, {'name': 'Peginterferon alfa-2b [PegIntron®]', 'type': 'DRUG', 'description': 'Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.', 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': 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