Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-04-03 @ 4:31 PM
Study NCT ID:
NCT02817594
Status:
COMPLETED
Last Update Posted:
2019-05-17
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C
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': 'From first dose of study drug through 30 days after last dose (16 weeks).', 'eventGroups': [{'id': 'EG000', 'title': '2 DAA', 'description': 'Participants received paritaprevir/ritonavir and ombitasvir for 12 weeks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 DAA + RBV', 'description': 'Participants received paritaprevir/ritonavir and ombitasvir plus ribavirin for 12 weeks.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3 DAA', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, dasabuvir, without ribavirin, for 12 weeks.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 22, 'seriousNumAtRisk': 34, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': '3 DAA + RBV', 'description': 'Participants received paritaprevir/ritonavir, ombitasvir, and dasabuvir plus ribavirin for 12 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'EYE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'SENSE OF OPPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'HERPES ZOSTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'WHITE BLOOD CELL COUNT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'BURSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'DEPRESSED MOOD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'RESTLESSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'SLEEP DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'NOCTURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'DYSHIDROTIC ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000', 'lowerLimit': '77.8', 'upperLimit': '95.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)', 'description': 'Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population, defined as enrolled participants 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 Achieving Virological Response at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '98.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment (week 12 or 24 depending on the treatment regimen)', 'description': 'Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population defined as enrolled participants 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 Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000', 'lowerLimit': '80.1', 'upperLimit': '96.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)', 'description': 'Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.\n\nThe Core Population with sufficient follow-up data regarding SVR12 included all core population participants who\n\n* had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE REGIMEN\n* or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline\n* or had HCV RNA \\< 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population with sufficient follow-up data regarding SVR12'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '18.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.', 'description': 'Relapse was defined as participants with a virologic response (VR; HCV RNA \\< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population with VR at EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Breakthrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '32.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 or 24 weeks (depending on the treatment regimen)', 'description': 'Breakthrough was defined as at least one 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': 'The Core Population with virological response on-treatment and with at least one on-treatment measurement thereafter (including EOT).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'On-treatment virologic failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Relapse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Premature treatment discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'None of the above criteria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)', 'description': 'SVR12 non-response was categorized according to the following:\n\n* On-treatment virologic failure (breakthrough \\[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 EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);\n* Premature treatment discontinuation with no on-treatment virologic failure;\n* Missing SVR12 data and/or none of the above criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population'}, {'type': 'SECONDARY', 'title': 'Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'title': '> 105 %', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '> 95% to ≤ 105%', 'measurements': [{'value': '41', 'groupId': 'OG000'}]}, {'title': '> 80% to ≤ 95%', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '> 50% to ≤ 80%', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '≤ 50%', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.', 'description': 'Adherence to study treatment was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population'}, {'type': 'SECONDARY', 'title': 'Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'title': '> 105%', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '> 95% to ≤ 105%', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': '> 80% to ≤ 95%', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '> 50% to ≤ 80%', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '≤ 50%', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen', 'description': 'Adherence to study treatment was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population who were prescribed ribavirin.'}, {'type': 'SECONDARY', 'title': 'Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.0', 'spread': '19.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population who were prescribed ribavirin.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pregnancy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug through 30 days after last dose (16 weeks).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population, defined as all enrolled participants who received at least one dose of the ABBVIE regimen.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-0.131', 'upperLimit': '0.015'}]}]}, {'title': '12 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-0.082', 'upperLimit': '0.096'}]}]}, {'title': '24 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '-0.084', 'upperLimit': '0.115'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': "The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L 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 visual analog scale (VAS).\n\nResponses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-15.0', 'upperLimit': '5.0'}]}]}, {'title': '12 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-10.0', 'upperLimit': '11.0'}]}]}, {'title': '24 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-10.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The EQ-5D-5L is a health state utility instrument that evaluates preference for health status with a separate visual analog scale (VAS).\n\nThe VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population with available data at baseline and each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': '12 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': '24 weeks after end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '42.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.\n\nAbsenteeism indicates the percentage of work time missed due to health problems.', 'unitOfMeasure': 'percent impairment', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Core Population who were employed and with available data at baseline and each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.\n\nThe prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'comment': 'Completed defined as having an HCV RNA assessment performed at least 10 weeks post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Did Not Receive Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants chronically infected with hepatitis C virus (HCV) were enrolled at 9 centers in the Netherlands.', 'preAssignmentDetails': 'Participants were prescribed the interferon-free combination regimen of paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) at the discretion of the physician in accordance with local clinical practice and label.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks, according to HCV genotype/subtype and stage of liver disease.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53', 'spread': '12.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Hepatitis C Virus Genotype', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Genotype 1a', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Genotype 1b', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Genotype 4a', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Genotype 4d', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Genotype 4n', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Genotype 4r', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Genotype 4, Subtype Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cirrhosis status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'No cirrhosis', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Transition to cirrhosis', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Cirrhosis', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Years Since Diagnosis of HCV Infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '12.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'HCV Ribonucleic Acid (RNA) Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.98', 'spread': '0.925', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with non-missing RNA data.'}, {'title': 'Assigned Treatment Regimen', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': '2 DAA without RBV for 12 weeks', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '2 DAA with RBV for 12 weeks', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '3 DAA without RBV for 12 weeks', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': '3 DAA with RBV for 12 weeks', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two (paritaprevir/ritonavir and ombitasvir) or three (paritaprevir/ritonavir, ombitasvir, and dasabuvir) direct-acting antiviral (DAA) drugs with or without ribavirin for 12 or 24 weeks.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-28', 'size': 517867, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-18T13:09', 'hasProtocol': False}, {'date': '2018-03-26', 'size': 963776, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-18T13:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-15', 'studyFirstSubmitDate': '2016-06-27', 'resultsFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-15', 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)', 'timeFrame': '12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)', 'description': 'Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Virological Response at End of Treatment', 'timeFrame': 'End of treatment (week 12 or 24 depending on the treatment regimen)', 'description': 'Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.'}, {'measure': 'Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment', 'timeFrame': '12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)', 'description': 'Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.\n\nThe Core Population with sufficient follow-up data regarding SVR12 included all core population participants who\n\n* had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE REGIMEN\n* or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline\n* or had HCV RNA \\< 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure.'}, {'measure': 'Percentage of Participants With Relapse', 'timeFrame': 'End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.', 'description': 'Relapse was defined as participants with a virologic response (VR; HCV RNA \\< 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.'}, {'measure': 'Percentage of Participants With Breakthrough', 'timeFrame': '12 or 24 weeks (depending on the treatment regimen)', 'description': 'Breakthrough was defined as at least one documented HCV RNA \\< 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.'}, {'measure': 'Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment', 'timeFrame': '12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)', 'description': 'SVR12 non-response was categorized according to the following:\n\n* On-treatment virologic failure (breakthrough \\[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 EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);\n* Premature treatment discontinuation with no on-treatment virologic failure;\n* Missing SVR12 data and/or none of the above criteria.'}, {'measure': 'Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.', 'description': 'Adherence to study treatment was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration)'}, {'measure': 'Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen', 'description': 'Adherence to study treatment was calculated as:\n\nCumulative dose taken / (initial prescribed dose \\* planned duration)'}, {'measure': 'Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days', 'timeFrame': 'From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.'}, {'measure': 'Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies', 'timeFrame': 'From first dose of study drug through 30 days after last dose (16 weeks).'}, {'measure': 'Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score', 'timeFrame': 'Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': "The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L 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 visual analog scale (VAS).\n\nResponses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status."}, {'measure': 'Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score', 'timeFrame': 'Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The EQ-5D-5L is a health state utility instrument that evaluates preference for health status with a separate visual analog scale (VAS).\n\nThe VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism', 'timeFrame': 'Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment', 'description': 'The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.\n\nAbsenteeism indicates the percentage of work time missed due to health problems.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Hepatitis C', 'Paritaprevir/r - Ombitasvir, ± Dasabuvir', 'Sustained Virological Response', 'Observational Study', 'Chronic Hepatitis C genotype 1', 'Chronic Hepatitis C genotype 4'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.\n\nThis observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in the Netherlands in a clinical practice patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN will be offered the opportunity to participate in this study during a routine clinical visit at the participating sites.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± 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* Participants must voluntarily sign and date informed consent prior to inclusion into the study\n\nExclusion Criteria:\n\n* Patients participating or intending to participate in a concurrent interventional therapeutic trial.\n* Unable to complete the questionnaires due to cognitive impairment or lack of any kind of cognitive competence, as to be judged by the healthcare professional who is treating the patient.\n* Unable to complete the questionnaires due to language incompetence.\n* Unable to voluntarily sign and date the informed consent.'}, 'identificationModule': {'nctId': 'NCT02817594', 'acronym': '3DUTCH', 'briefTitle': 'Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C', '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 The Netherlands (3DUTCH)', 'orgStudyIdInfo': {'id': 'P15-788'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin', 'description': 'Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease.\n\nThe prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3318 AT', 'city': 'Dordrecht', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Albert Schweitzer Ziekenhuis /ID# 152597', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'zip': '1815 JD', 'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Noordwest Ziekenhuisgroep /ID# 152604', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '1061 AE', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Duplicate_Onze Lieve Vrouwe Gasthuis /ID# 152600', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen /ID# 152596', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leids Universitair Medisch Centrum /ID# 154637', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6526 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radbound University Medical Ce /ID# 152598', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medisch Centrum /ID# 154635', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3079 DZ', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Maasstad Ziekenhuis /ID# 152592', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Utrecht /ID# 152595', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}