Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-01 @ 9:51 PM
Study NCT ID:
NCT02851069
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety was assessed only as treatment emergent adverse events (TEAEs) as recorded by the treating physician. TEAEs were collected after the first dose of study drug through 30 days after last dose of study drug.', 'description': "TEAEs were defined as any adverse event (AE) with onset date after the first dose of study drug until 30 days after last dose of study drug. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's informed consent form until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment.", 'eventGroups': [{'id': 'EG000', 'title': 'ABBVIE REGIMEN', 'description': 'ABBVIE REGIMEN: ombitasvir/paritaprevir/ritonavir with or without dasabuvir for 12 or 24 weeks in Hepatitis C Virus Genotype 1 (HCV + GT1) participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 5, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'ABBVIE REGIMEN Plus Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN plus ribavirin (RBV): ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with weight-based RBV for 12 or 24 weeks in HCV + GT1 participants according to standard of care within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 9, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'TREATMENT FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'HEPATITIS C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'CYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'HAEMORRHOIDAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'RECTAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'HEPATIC CIRRHOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'HEPATIC FIBROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'HEPATOTOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'HYPERBILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'PERITONITIS BACTERIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '77.5', 'upperLimit': '93.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)', 'description': 'SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN \\[paritaprevir/ritonavir - ombitasvir ± dasabuvir\\] or ribavirin \\[RBV\\]).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Core Population (CP): defined as all participants of the target population (all participants in the safety population who met inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Response at End of Treatment (EoT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '98.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to EoT, maximum of 24 weeks', 'description': 'Virologic response is defined as HCV RNA level \\<50 IU/mL.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'CP'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting Premature Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'title': 'Premature Termination ABBVIE REGIMEN', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'No Premature Termination ABBVIE REGIMEN', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to EoT, maximum of 24 weeks', 'description': 'Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough \\[at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment\\] or failure to suppress \\[each measured on-treatment HCV RNA value ≥50 IU/mL\\]).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CP'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'title': 'Non-response 12 weeks after EoT', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}]}]}, {'title': 'On-treatment virologic failure', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Relapse', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Premature treatment discontinuation', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}]}]}, {'title': 'Missing SVR12 data/None of the above criteria', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)', 'description': 'For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:\n\n* On-treatment virologic failure (breakthrough \\[defined as at least one documented HCV RNA \\<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment\\] or failure to suppress \\[each measured on-treatment HCV RNA value ≥50 IU/mL\\]);\n* Relapse (defined as HCV RNA \\<50 IU/mL at actual EoT followed by HCV RNA ≥50 IU/mL post-treatment for participants who completed treatment \\[not more than 7 days shortened\\]);\n* Premature study drug discontinuation with no on-treatment virologic failure;\n* Missing SVR12 data and/or none of the above criteria (including participants with missing SVR12 data).\n\nAbbreviations: EoT=end of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CP'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (i.e. at least 70 days) after the last dose of study drug', 'description': 'Relapse was defined as confirmed HCV RNA \\<50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CP'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse at EoT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks (i.e. at least 70 days) after the last dose of study drug', 'description': 'Relapse was defined as confirmed HCV RNA \\<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'CP of participants with EoT response whose last post-treatment HCV RNA test result did not show virologic response'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Viral Breakthrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to EoT, maximum of 24 weeks', 'description': 'Viral breakthrough was defined as at least 1 documented HCV RNA \\<50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'CP'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting On-treatment Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to EoT, maximum of 24 weeks', 'description': 'On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA \\<50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CP'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '76.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR4 was defined as HCV RNA \\< 50 IU/mL at Week 4.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'CP'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '73.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after EoT (up to 24 weeks)', 'description': 'SVR24 was defined as HCV RNA \\< 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'CP participants with an SVR24 assessment'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.005', 'spread': '0.143', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'EoT (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.039', 'spread': '0.122', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post EoT (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.046', 'spread': '0.111', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks post EoT (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '10.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Treatment (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '16.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post EoT (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '12.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks post EoT (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Co-morbidities at Baseline (Day 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'title': 'All co-morbidities and co-infections', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'HCV Co-infections', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Liver and/or CHC related co-morbidities', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Other Co-morbidities', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Kidney Transplantation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Kidney Disease', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatric Disorders', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Diabetes Mellitus', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Lipid Disorder', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Hypothyroidism', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular disease', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Hemophilia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0)', 'description': 'Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus \\[HIV\\] or hepatitis B virus \\[HBV\\], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CP'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'classes': [{'title': 'Number taking at least 1 co-medication', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Beta Blocking Agents', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid Therapy', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Vitamins', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Angiotensin II Antagonists', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Drugs for Peptic Ulcer and GERD', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Blood glucose lowering', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Diuretics', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Analgesics', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Calcium Channel Blockers', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'ACE Inhibitors', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Mineral Supplements', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Antidepressants', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Drugs for treatment of bone disease', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'HMG COA Reductase Inhibitors', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Anti-anemic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Antibacterials', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Antithrombotic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Dermatologicals', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Drugs for Constipation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Immunosuppressive agents', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Anti-asthmatics', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Insulin and Analogues', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Anti-andrenergic Antihypertensives', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Anti-arrhythmics', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Antidiarrheals', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Anti-inflammatory/antirheumatic products', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Antineoplastic,immunomodulating agents, cytostatic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Antipsychotics', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Antivirals for HIV, combinations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Antivirals, reverse transcriptase inhibitors HIV', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Benzodiazepine derivatives', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bile therapy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Blood substitutes/perfusion solutions', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hemostatics/vitamin K', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lipotropics', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other antivirals, HIV treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other Sex hormones', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Vasoprotectives', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to EoT, maximum 24 weeks', 'description': 'This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.\n\nAbbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: defined as all enrolled participants who received at least one dose of the ABBVIE REGIMEN'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Received at least 1 dose of study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Failure to Return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 66 participants were enrolled in the study; 1 participant never started treatment and thus the safety population was comprised of 65 participants. In this study, the safety population, target population, and core population were identical.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ABBVIE REGIMEN ± Ribavirin (RBV)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir), and with or without weight-based ribavirin (± RBV) for 12 or 24 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Core Population (CP): defined as all participants of the target population (all participants in the safety population who met inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-30', 'size': 9665714, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-22T14:45', 'hasProtocol': True}, {'date': '2017-12-18', 'size': 661430, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-22T14:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2016-07-28', 'resultsFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2016-07-29', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-12', 'studyFirstPostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT', 'timeFrame': 'EoT (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health).'}, {'measure': 'EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT', 'timeFrame': '12 weeks post EoT (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).'}, {'measure': 'EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT', 'timeFrame': '24 weeks post EoT (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).'}, {'measure': 'EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT', 'timeFrame': 'End of Treatment (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.'}, {'measure': 'EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT', 'timeFrame': '12 weeks post EoT (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.'}, {'measure': 'EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT', 'timeFrame': '24 weeks post EoT (up to 24 weeks)', 'description': 'The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.'}, {'measure': 'Number of Participants With Co-morbidities at Baseline (Day 0)', 'timeFrame': 'Baseline (Day 0)', 'description': 'Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus \\[HIV\\] or hepatitis B virus \\[HBV\\], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other).'}, {'measure': 'Number of Participants With Concomitant Medications', 'timeFrame': 'Day 0 to EoT, maximum 24 weeks', 'description': 'This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.\n\nAbbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment', 'timeFrame': '12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)', 'description': 'SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN \\[paritaprevir/ritonavir - ombitasvir ± dasabuvir\\] or ribavirin \\[RBV\\]).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Virologic Response at End of Treatment (EoT)', 'timeFrame': 'Up to EoT, maximum of 24 weeks', 'description': 'Virologic response is defined as HCV RNA level \\<50 IU/mL.'}, {'measure': 'Number of Participants Meeting Premature Study Drug Discontinuation', 'timeFrame': 'Up to EoT, maximum of 24 weeks', 'description': 'Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough \\[at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment\\] or failure to suppress \\[each measured on-treatment HCV RNA value ≥50 IU/mL\\]).'}, {'measure': 'Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria', 'timeFrame': 'During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)', 'description': 'For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:\n\n* On-treatment virologic failure (breakthrough \\[defined as at least one documented HCV RNA \\<50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment\\] or failure to suppress \\[each measured on-treatment HCV RNA value ≥50 IU/mL\\]);\n* Relapse (defined as HCV RNA \\<50 IU/mL at actual EoT followed by HCV RNA ≥50 IU/mL post-treatment for participants who completed treatment \\[not more than 7 days shortened\\]);\n* Premature study drug discontinuation with no on-treatment virologic failure;\n* Missing SVR12 data and/or none of the above criteria (including participants with missing SVR12 data).\n\nAbbreviations: EoT=end of treatment.'}, {'measure': 'Percentage of Participants With Relapse', 'timeFrame': '12 weeks (i.e. at least 70 days) after the last dose of study drug', 'description': 'Relapse was defined as confirmed HCV RNA \\<50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated.'}, {'measure': 'Percentage of Participants With Relapse at EoT', 'timeFrame': '12 weeks (i.e. at least 70 days) after the last dose of study drug', 'description': 'Relapse was defined as confirmed HCV RNA \\<50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window.'}, {'measure': 'Percentage of Participants With Viral Breakthrough', 'timeFrame': 'Up to EoT, maximum of 24 weeks', 'description': 'Viral breakthrough was defined as at least 1 documented HCV RNA \\<50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.'}, {'measure': 'Percentage of Participants Meeting On-treatment Virologic Failure', 'timeFrame': 'Up to EoT, maximum of 24 weeks', 'description': 'On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA \\<50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL).'}, {'measure': 'Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)', 'timeFrame': 'Week 4', 'description': 'RVR4 was defined as HCV RNA \\< 50 IU/mL at Week 4.'}, {'measure': 'Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT', 'timeFrame': '24 weeks after EoT (up to 24 weeks)', 'description': 'SVR24 was defined as HCV RNA \\< 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Hepatitis C', 'Paritaprevir/r - Ombitasvir, ± Dasabuvir', 'Sustained Virological Response', 'Observational Study', 'Chronic Hepatitis C genotype 1'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '30739368', 'type': 'DERIVED', 'citation': 'Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.'}]}, 'descriptionModule': {'briefSummary': "This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label.\n\nThis study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.", 'detailedDescription': "This prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN with or without RBV are offered the opportunity to participate in this study during a routine clinical visit at the participating sites at the discretion of the physician and is made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study.\n\nAfter written informed consent is obtained, demographics, HCV disease characteristics, co-morbidities, co-medication, treatment details, and laboratory assessments as recorded in the participant's medical records (source documentation) are documented in the electronic case report form (eCRF). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion. No patient identifiable information was captured; a unique participant number was automatically allocated by the web based system once the investigator or designee created a new participant file.\n\nThis study focuses on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods follow physicians' routine clinical practice. The observational study period entailed the following data collection schemes:\n\n* 12-week treatment regimen: four visits plus two interim data collection windows\n* 24-week treatment regimen: four visits plus three interim data collection windows This schedule was based on the anticipated regular follow-up for patients undergoing treatment for CHC."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with chronic hepatitis C (CHC), genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) ± ribavirin (RBV) according to standard of care and in line with the current local label.\n* If RBV is co-administered with the ABBVIE REGIMEN , it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).\n* Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT02851069', 'acronym': 'outCome', 'briefTitle': 'Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Colombia (outCome)', 'orgStudyIdInfo': {'id': 'P16-024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Hepatitis C Virus Genotype 1 (HCV + GT1)', 'description': 'ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir \\[25 mg/150 mg/100 mg once daily\\] with or without dasabuvir \\[250 mg twice daily\\]), and with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks in HCV + GT1 participants.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Fundacion Cardioinfantil', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '760001', 'city': 'Cali', 'country': 'Colombia', 'facility': 'Cic Cali', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'Centro Medico lmbanaco de Cali I', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '130013', 'city': 'Cartagena', 'country': 'Colombia', 'facility': 'Pharos Centro de Estudios Clin', 'geoPoint': {'lat': 10.39817, 'lon': -75.49328}}, {'zip': '170004', 'city': 'Manizales', 'country': 'Colombia', 'facility': 'IPS Medicos Internistas Del Ca I', 'geoPoint': {'lat': 5.0668, 'lon': -75.50684}}, {'zip': '050010', 'city': 'Medellín', 'country': 'Colombia', 'facility': 'Fundacion Hospitalaria San Vin', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}