Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-29 @ 12:06 AM
Study NCT ID:
NCT00905632
Status:
COMPLETED
Last Update Posted:
2016-04-19
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592437', 'term': 'deleobuvir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BIs intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From drug administration until 2 days after the end of treatment, up to 570 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BI 207127 400 mg', 'description': 'patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days', 'otherNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'BI 207127 600 mg', 'description': 'patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days', 'otherNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'BI 207127 800 mg', 'description': 'patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days', 'otherNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Myopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Abdominal rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Gastrointestinal hypermotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Mucosal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Excessive granulation tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}], 'seriousEvents': [{'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG006', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The primary efficacy endpoint is the number of participants with virologic response defined as \\>= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as \\>= 1 log increase in viral load from nadir.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the treated set (TS) that had at least one measurement of efficacy.'}, {'type': 'SECONDARY', 'title': 'Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG006', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'Day 1 (02:00 hours) (N=8,5,7,6,10,9,11)', 'categories': [{'measurements': [{'value': '-0.04', 'groupId': 'OG000', 'lowerLimit': '-0.27', 'upperLimit': '0.14'}, {'value': '-0.09', 'groupId': 'OG001', 'lowerLimit': '-0.13', 'upperLimit': '0.03'}, {'value': '-0.01', 'groupId': 'OG002', 'lowerLimit': '-0.26', 'upperLimit': '0.37'}, {'value': '-0.06', 'groupId': 'OG003', 'lowerLimit': '-0.19', 'upperLimit': '0.08'}, {'value': '0.02', 'groupId': 'OG004', 'lowerLimit': '-0.15', 'upperLimit': '0.15'}, {'value': '0.04', 'groupId': 'OG005', 'lowerLimit': '-0.13', 'upperLimit': '0.16'}, {'value': '0.03', 'groupId': 'OG006', 'lowerLimit': '-0.25', 'upperLimit': '0.25'}]}]}, {'title': 'Day 1 (04:00 hours) (N=8,5,7,6,10,9,11)', 'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '0.04'}, {'value': '-0.27', 'groupId': 'OG001', 'lowerLimit': '-0.36', 'upperLimit': '-0.11'}, {'value': '-0.28', 'groupId': 'OG002', 'lowerLimit': '-0.54', 'upperLimit': '0.07'}, {'value': '-0.29', 'groupId': 'OG003', 'lowerLimit': '-0.56', 'upperLimit': '0.10'}, {'value': '-0.10', 'groupId': 'OG004', 'lowerLimit': '-0.37', 'upperLimit': '0.08'}, {'value': '-0.09', 'groupId': 'OG005', 'lowerLimit': '-0.36', 'upperLimit': '0.21'}, {'value': '-0.01', 'groupId': 'OG006', 'lowerLimit': '-0.81', 'upperLimit': '0.31'}]}]}, {'title': 'Day 1 (05:55 hours) (N=8,5,7,6,10,9,11)', 'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.10'}, {'value': '-0.53', 'groupId': 'OG001', 'lowerLimit': '-0.95', 'upperLimit': '-0.13'}, {'value': '-0.79', 'groupId': 'OG002', 'lowerLimit': '-1.32', 'upperLimit': '-0.19'}, {'value': '-1.09', 'groupId': 'OG003', 'lowerLimit': '-1.26', 'upperLimit': '-0.50'}, {'value': '-0.37', 'groupId': 'OG004', 'lowerLimit': '-0.93', 'upperLimit': '-0.09'}, {'value': '-0.55', 'groupId': 'OG005', 'lowerLimit': '-0.97', 'upperLimit': '0.19'}, {'value': '-0.11', 'groupId': 'OG006', 'lowerLimit': '-1.53', 'upperLimit': '0.01'}]}]}, {'title': 'Day 1 (08:00 hours) (N=8,5,7,6,10,9,11)', 'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000', 'lowerLimit': '-0.51', 'upperLimit': '0.18'}, {'value': '-1.04', 'groupId': 'OG001', 'lowerLimit': '-1.52', 'upperLimit': '-0.49'}, {'value': '-1.30', 'groupId': 'OG002', 'lowerLimit': '-2.09', 'upperLimit': '-0.54'}, {'value': '-1.72', 'groupId': 'OG003', 'lowerLimit': '-2.12', 'upperLimit': '-0.51'}, {'value': '-0.69', 'groupId': 'OG004', 'lowerLimit': '-1.66', 'upperLimit': '-0.16'}, {'value': '-1.00', 'groupId': 'OG005', 'lowerLimit': '-1.77', 'upperLimit': '-0.03'}, {'value': '-0.46', 'groupId': 'OG006', 'lowerLimit': '-2.07', 'upperLimit': '-0.01'}]}]}, {'title': 'Day 1 (10:00 hours) (N=8,5,7,6,10,9,11)', 'categories': [{'measurements': [{'value': '-0.06', 'groupId': 'OG000', 'lowerLimit': '-0.34', 'upperLimit': '0.15'}, {'value': '-1.15', 'groupId': 'OG001', 'lowerLimit': '-2.13', 'upperLimit': '-0.53'}, {'value': '-1.70', 'groupId': 'OG002', 'lowerLimit': '-2.53', 'upperLimit': '-0.77'}, {'value': '-1.99', 'groupId': 'OG003', 'lowerLimit': '-2.75', 'upperLimit': '-1.41'}, {'value': '-0.80', 'groupId': 'OG004', 'lowerLimit': '-1.80', 'upperLimit': '-0.44'}, {'value': '-1.18', 'groupId': 'OG005', 'lowerLimit': '-2.44', 'upperLimit': '-0.22'}, {'value': '-0.79', 'groupId': 'OG006', 'lowerLimit': '-2.45', 'upperLimit': '-0.20'}]}]}, {'title': 'Day 1 (11:55 hours) (N=8,5,7,6,10,9,11)', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.20'}, {'value': '-1.50', 'groupId': 'OG001', 'lowerLimit': '-2.51', 'upperLimit': '-0.54'}, {'value': '-2.38', 'groupId': 'OG002', 'lowerLimit': '-2.89', 'upperLimit': '-1.02'}, {'value': '-2.40', 'groupId': 'OG003', 'lowerLimit': '-3.22', 'upperLimit': '-1.55'}, {'value': '-1.11', 'groupId': 'OG004', 'lowerLimit': '-2.53', 'upperLimit': '-0.61'}, {'value': '-1.66', 'groupId': 'OG005', 'lowerLimit': '-2.72', 'upperLimit': '-0.42'}, {'value': '-1.01', 'groupId': 'OG006', 'lowerLimit': '-2.53', 'upperLimit': '-0.20'}]}]}, {'title': 'Day 1 (15:00 hours) (N=8,5,7,6,8,9,10)', 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-0.49', 'upperLimit': '0.05'}, {'value': '-2.13', 'groupId': 'OG001', 'lowerLimit': '-3.05', 'upperLimit': '-0.71'}, {'value': '-2.49', 'groupId': 'OG002', 'lowerLimit': '-3.36', 'upperLimit': '-1.30'}, {'value': '-2.86', 'groupId': 'OG003', 'lowerLimit': '-3.52', 'upperLimit': '-2.48'}, {'value': '-1.45', 'groupId': 'OG004', 'lowerLimit': '-3.02', 'upperLimit': '-0.92'}, {'value': '-2.48', 'groupId': 'OG005', 'lowerLimit': '-3.05', 'upperLimit': '-0.66'}, {'value': '-1.66', 'groupId': 'OG006', 'lowerLimit': '-2.79', 'upperLimit': '-0.78'}]}]}, {'title': 'Day 2 (N=8,5,7,6,10,8,11)', 'categories': [{'measurements': [{'value': '-0.39', 'groupId': 'OG000', 'lowerLimit': '-1.02', 'upperLimit': '0.24'}, {'value': '-1.78', 'groupId': 'OG001', 'lowerLimit': '-3.86', 'upperLimit': '-0.60'}, {'value': '-2.73', 'groupId': 'OG002', 'lowerLimit': '-4.07', 'upperLimit': '-2.18'}, {'value': '-3.32', 'groupId': 'OG003', 'lowerLimit': '-3.90', 'upperLimit': '-3.17'}, {'value': '-1.57', 'groupId': 'OG004', 'lowerLimit': '-3.54', 'upperLimit': '-0.46'}, {'value': '-2.46', 'groupId': 'OG005', 'lowerLimit': '-3.55', 'upperLimit': '-0.87'}, {'value': '-1.93', 'groupId': 'OG006', 'lowerLimit': '-2.98', 'upperLimit': '-0.62'}]}]}, {'title': 'Day 4 (N=8,5,7,6,10,9,11)', 'categories': [{'measurements': [{'value': '-0.61', 'groupId': 'OG000', 'lowerLimit': '-0.93', 'upperLimit': '0.04'}, {'value': '-2.43', 'groupId': 'OG001', 'lowerLimit': '-4.33', 'upperLimit': '-1.43'}, {'value': '-3.07', 'groupId': 'OG002', 'lowerLimit': '-5.25', 'upperLimit': '-2.95'}, {'value': '-3.80', 'groupId': 'OG003', 'lowerLimit': '-4.11', 'upperLimit': '-3.52'}, {'value': '-1.51', 'groupId': 'OG004', 'lowerLimit': '-4.15', 'upperLimit': '-0.54'}, {'value': '-2.76', 'groupId': 'OG005', 'lowerLimit': '-3.92', 'upperLimit': '-0.92'}, {'value': '-2.53', 'groupId': 'OG006', 'lowerLimit': '-3.54', 'upperLimit': '-1.19'}]}]}, {'title': 'Day 8 (N=8,5,7,6,10,9,9)', 'categories': [{'measurements': [{'value': '-0.32', 'groupId': 'OG000', 'lowerLimit': '-1.43', 'upperLimit': '0.26'}, {'value': '-3.19', 'groupId': 'OG001', 'lowerLimit': '-5.28', 'upperLimit': '-1.83'}, {'value': '-4.13', 'groupId': 'OG002', 'lowerLimit': '-6.36', 'upperLimit': '-3.28'}, {'value': '-4.31', 'groupId': 'OG003', 'lowerLimit': '-4.95', 'upperLimit': '-3.77'}, {'value': '-1.58', 'groupId': 'OG004', 'lowerLimit': '-4.86', 'upperLimit': '-0.36'}, {'value': '-3.04', 'groupId': 'OG005', 'lowerLimit': '-4.51', 'upperLimit': '-0.88'}, {'value': '-2.68', 'groupId': 'OG006', 'lowerLimit': '-4.08', 'upperLimit': '-1.90'}]}]}, {'title': 'Day 15 (N=7,5,7,6,10,8,8)', 'categories': [{'measurements': [{'value': '-0.42', 'groupId': 'OG000', 'lowerLimit': '-1.50', 'upperLimit': '-0.11'}, {'value': '-3.89', 'groupId': 'OG001', 'lowerLimit': '-5.74', 'upperLimit': '-2.96'}, {'value': '-5.27', 'groupId': 'OG002', 'lowerLimit': '-6.36', 'upperLimit': '-3.86'}, {'value': '-4.86', 'groupId': 'OG003', 'lowerLimit': '-5.20', 'upperLimit': '-4.45'}, {'value': '-2.09', 'groupId': 'OG004', 'lowerLimit': '-4.96', 'upperLimit': '-0.70'}, {'value': '-4.00', 'groupId': 'OG005', 'lowerLimit': '-5.60', 'upperLimit': '-1.37'}, {'value': '-3.26', 'groupId': 'OG006', 'lowerLimit': '-4.68', 'upperLimit': '-2.11'}]}]}, {'title': 'Day 22 (N=8,5,7,6,10,8 ,8)', 'categories': [{'measurements': [{'value': '-1.06', 'groupId': 'OG000', 'lowerLimit': '-2.78', 'upperLimit': '-0.45'}, {'value': '-4.53', 'groupId': 'OG001', 'lowerLimit': '-5.74', 'upperLimit': '-3.77'}, {'value': '-5.55', 'groupId': 'OG002', 'lowerLimit': '-6.36', 'upperLimit': '-4.62'}, {'value': '-5.27', 'groupId': 'OG003', 'lowerLimit': '-5.90', 'upperLimit': '-4.46'}, {'value': '-2.63', 'groupId': 'OG004', 'lowerLimit': '-4.96', 'upperLimit': '-1.42'}, {'value': '-3.83', 'groupId': 'OG005', 'lowerLimit': '-5.71', 'upperLimit': '-1.65'}, {'value': '-4.13', 'groupId': 'OG006', 'lowerLimit': '-4.98', 'upperLimit': '-2.40'}]}]}, {'title': 'Day 28 (N=7,5,6,6,10,8,7)', 'categories': [{'measurements': [{'value': '-1.41', 'groupId': 'OG000', 'lowerLimit': '-3.75', 'upperLimit': '-0.73'}, {'value': '-5.08', 'groupId': 'OG001', 'lowerLimit': '-5.74', 'upperLimit': '-4.32'}, {'value': '-5.61', 'groupId': 'OG002', 'lowerLimit': '-6.22', 'upperLimit': '-4.84'}, {'value': '-5.44', 'groupId': 'OG003', 'lowerLimit': '-5.90', 'upperLimit': '-4.93'}, {'value': '-2.86', 'groupId': 'OG004', 'lowerLimit': '-4.96', 'upperLimit': '-1.32'}, {'value': '-4.20', 'groupId': 'OG005', 'lowerLimit': '-6.14', 'upperLimit': '-1.20'}, {'value': '-4.48', 'groupId': 'OG006', 'lowerLimit': '-5.41', 'upperLimit': '-2.99'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and days 1, 2, 4, 8, 15, 22 and 28', 'description': 'Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit.\n\nA negative value represents an increase in viral load, a positive value represents a decrease in viral load.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available viral load data at baseline and day 28.'}, {'type': 'SECONDARY', 'title': 'Viral Load at Each Visit up to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG006', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'Baseline (N=8,4,7,6,9,9,11)', 'categories': [{'measurements': [{'value': '3540000', 'groupId': 'OG000', 'lowerLimit': '925000', 'upperLimit': '10900000'}, {'value': '3260000', 'groupId': 'OG001', 'lowerLimit': '572000', 'upperLimit': '4910000'}, {'value': '8480000', 'groupId': 'OG002', 'lowerLimit': '629000', 'upperLimit': '20600000'}, {'value': '3440000', 'groupId': 'OG003', 'lowerLimit': '763000', 'upperLimit': '19000000'}, {'value': '3620000', 'groupId': 'OG004', 'lowerLimit': '1330000', 'upperLimit': '17400000'}, {'value': '3560000', 'groupId': 'OG005', 'lowerLimit': '684000', 'upperLimit': '12300000'}, {'value': '3340000', 'groupId': 'OG006', 'lowerLimit': '665000', 'upperLimit': '45300000'}]}]}, {'title': 'Day 8 (N=8,3,6,6,9,9,9)', 'categories': [{'measurements': [{'value': '1520000', 'groupId': 'OG000', 'lowerLimit': '34500', 'upperLimit': '19700000'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '320', 'groupId': 'OG002', 'lowerLimit': '42.0', 'upperLimit': '3200'}, {'value': '234', 'groupId': 'OG003', 'lowerLimit': '28.0', 'upperLimit': '913'}, {'value': '47800', 'groupId': 'OG004', 'lowerLimit': '30', 'upperLimit': '2300000'}, {'value': '4120', 'groupId': 'OG005', 'lowerLimit': '161', 'upperLimit': '89400'}, {'value': '8460', 'groupId': 'OG006', 'lowerLimit': '108', 'upperLimit': '566000'}]}]}, {'title': 'Day 15 (N=7,2,3,4,8,8,7)', 'categories': [{'measurements': [{'value': '618000', 'groupId': 'OG000', 'lowerLimit': '92800', 'upperLimit': '6470000'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '107', 'groupId': 'OG003', 'lowerLimit': '28.0', 'upperLimit': '188'}, {'value': '18100', 'groupId': 'OG004', 'lowerLimit': '367', 'upperLimit': '626000'}, {'value': '690', 'groupId': 'OG005', 'lowerLimit': '31', 'upperLimit': '153000'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 22 (N=8,1,2,2,8,5,6)', 'categories': [{'measurements': [{'value': '249000', 'groupId': 'OG000', 'lowerLimit': '1550', 'upperLimit': '3870000'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '29600', 'groupId': 'OG004', 'lowerLimit': '554', 'upperLimit': '70400'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 28 (N=7,1,2,0,7,5,4)', 'categories': [{'measurements': [{'value': '168000', 'groupId': 'OG000', 'lowerLimit': '133', 'upperLimit': '1620000'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No patients with available data at this timepoint.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '43100', 'groupId': 'OG004', 'lowerLimit': '685', 'upperLimit': '373000'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 of subjects had detectable data.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and days 8, 15, 22 and 28', 'description': 'Viral load (VL) (original values) at each visit up to day 28.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) set which included patients in the treated set but excluded VL values after recorded treatment stop time and values after subjects took wrong or additional doses of treatment. Also one patient was excluded from all descriptive PD summaries due to a protocol violation and another excluded as they did not have a predose VL value.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Virologic Response at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG006', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 28', 'description': 'Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), \\<10 IU/mL, at day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Rapid Virological Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG006', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Early Virological Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG006', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'Number of responders', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}, {'title': 'Number of failures', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 12', 'description': 'Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders\\* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With End of Treatment Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG006', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'Number of responders', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Number of failures', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders\\* - Response = Viral load below the limit of detection at end of all treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sustained Virological Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG006', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'Number of responders', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Number of failures', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until end of treatment, up to 570 days', 'description': 'Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (\\<10 IU/mL) at least 85 days after stopping standard care (SOC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration Time Profiles of BI 207127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'BI 207127 0.5 hours (N=4,6,6,-,8,-)', 'categories': [{'measurements': [{'value': '111', 'spread': '344', 'groupId': 'OG000'}, {'value': '103', 'spread': '534', 'groupId': 'OG001'}, {'value': '230', 'spread': '391', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Some patients had data below the limit of quantification which is not analysable and per internal rules, descriptive statistics are not calculated unless data from at least 2/3rds of all subjects were available.', 'groupId': 'OG003'}, {'value': '422', 'spread': '265', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Some patients had data below the limit of quantification which is not analysable and per internal rules, descriptive statistics are not calculated unless data from at least 2/3rds of all subjects were available.', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 3 hours (N=6,7,6,9,9,10)', 'categories': [{'measurements': [{'value': '2040', 'spread': '32.4', 'groupId': 'OG000'}, {'value': '2610', 'spread': '76.0', 'groupId': 'OG001'}, {'value': '5730', 'spread': '52.4', 'groupId': 'OG002'}, {'value': '3070', 'spread': '64.3', 'groupId': 'OG003'}, {'value': '4650', 'spread': '90.4', 'groupId': 'OG004'}, {'value': '4460', 'spread': '59.8', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 8 hours (N=6,7,6,9,9,11)', 'categories': [{'measurements': [{'value': '2590', 'spread': '29.0', 'groupId': 'OG000'}, {'value': '4610', 'spread': '124', 'groupId': 'OG001'}, {'value': '12600', 'spread': '65.3', 'groupId': 'OG002'}, {'value': '4320', 'spread': '81.1', 'groupId': 'OG003'}, {'value': '6070', 'spread': '67.3', 'groupId': 'OG004'}, {'value': '7140', 'spread': '73.1', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 15 hours (N=6,7,6,8,9,10)', 'categories': [{'measurements': [{'value': '3550', 'spread': '55.3', 'groupId': 'OG000'}, {'value': '6530', 'spread': '55.9', 'groupId': 'OG001'}, {'value': '13500', 'spread': '62.8', 'groupId': 'OG002'}, {'value': '4860', 'spread': '115', 'groupId': 'OG003'}, {'value': '7270', 'spread': '93.4', 'groupId': 'OG004'}, {'value': '13300', 'spread': '67.2', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 23.917 hours (N=6,7,6,9,8,11)', 'categories': [{'measurements': [{'value': '595', 'spread': '72.0', 'groupId': 'OG000'}, {'value': '1610', 'spread': '138', 'groupId': 'OG001'}, {'value': '4780', 'spread': '76.4', 'groupId': 'OG002'}, {'value': '1170', 'spread': '201', 'groupId': 'OG003'}, {'value': '3450', 'spread': '173', 'groupId': 'OG004'}, {'value': '9350', 'spread': '71.0', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 503.917 hours (N=6,7,5,9,8,8)', 'categories': [{'measurements': [{'value': '336', 'spread': '101', 'groupId': 'OG000'}, {'value': '1250', 'spread': '302', 'groupId': 'OG001'}, {'value': '1730', 'spread': '146', 'groupId': 'OG002'}, {'value': '330', 'spread': '104', 'groupId': 'OG003'}, {'value': '709', 'spread': '167', 'groupId': 'OG004'}, {'value': '4460', 'spread': '249', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 649 hours (N=6,7,6,9,8,7)', 'categories': [{'measurements': [{'value': '1210', 'spread': '91.4', 'groupId': 'OG000'}, {'value': '2490', 'spread': '176', 'groupId': 'OG001'}, {'value': '2340', 'spread': '197', 'groupId': 'OG002'}, {'value': '1050', 'spread': '100', 'groupId': 'OG003'}, {'value': '1710', 'spread': '153', 'groupId': 'OG004'}, {'value': '3050', 'spread': '182', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 652 hours (N=6,7,6,9,8,7)', 'categories': [{'measurements': [{'value': '2520', 'spread': '86.3', 'groupId': 'OG000'}, {'value': '5100', 'spread': '100', 'groupId': 'OG001'}, {'value': '11300', 'spread': '68.6', 'groupId': 'OG002'}, {'value': '2650', 'spread': '66.3', 'groupId': 'OG003'}, {'value': '5340', 'spread': '60.0', 'groupId': 'OG004'}, {'value': '9070', 'spread': '106', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 656 hours (N=5,7,6,8,8,6)', 'categories': [{'measurements': [{'value': '905', 'spread': '113', 'groupId': 'OG000'}, {'value': '1940', 'spread': '121', 'groupId': 'OG001'}, {'value': '2820', 'spread': '145', 'groupId': 'OG002'}, {'value': '635', 'spread': '82.7', 'groupId': 'OG003'}, {'value': '1380', 'spread': '97.5', 'groupId': 'OG004'}, {'value': '3820', 'spread': '122', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 672 hours (N=5,7,6,-,8,6)', 'categories': [{'measurements': [{'value': '57.7', 'spread': '137', 'groupId': 'OG000'}, {'value': '80.4', 'spread': '306', 'groupId': 'OG001'}, {'value': '101', 'spread': '175', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Some patients had data below the limit of quantification which is not analysable and per internal rules, descriptive statistics are not calculated unless data from at least 2/3rds of all subjects were available.', 'groupId': 'OG003'}, {'value': '62.4', 'spread': '105', 'groupId': 'OG004'}, {'value': '163', 'spread': '236', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration', 'description': 'Plasma concentration time profiles of BI 207127', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration Time Profiles of CD 6168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'CD 6168 0.5 hours (N=-,-,-,-,-,-)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated as all participants results were below the limit of quantification.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated as all participants results were below the limit of quantification.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated as all participants results were below the limit of quantification.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated as all participants results were below the limit of quantification.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated as all participants results were below the limit of quantification.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated as all participants results were below the limit of quantification.', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 3 hours (N=6,7,6,9,8,11)', 'categories': [{'measurements': [{'value': '124', 'spread': '152', 'groupId': 'OG000'}, {'value': '155', 'spread': '68.1', 'groupId': 'OG001'}, {'value': '397', 'spread': '47.6', 'groupId': 'OG002'}, {'value': '142', 'spread': '63.4', 'groupId': 'OG003'}, {'value': '247', 'spread': '58.1', 'groupId': 'OG004'}, {'value': '183', 'spread': '144', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 8 hours (N=6,7,6,9,9,11)', 'categories': [{'measurements': [{'value': '337', 'spread': '61.6', 'groupId': 'OG000'}, {'value': '636', 'spread': '97.3', 'groupId': 'OG001'}, {'value': '1220', 'spread': '39.0', 'groupId': 'OG002'}, {'value': '307', 'spread': '79.1', 'groupId': 'OG003'}, {'value': '545', 'spread': '64.1', 'groupId': 'OG004'}, {'value': '622', 'spread': '54.8', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 15 hours (N=6,7,5,8,9,10)', 'categories': [{'measurements': [{'value': '690', 'spread': '57.8', 'groupId': 'OG000'}, {'value': '1320', 'spread': '55.2', 'groupId': 'OG001'}, {'value': '2210', 'spread': '47.0', 'groupId': 'OG002'}, {'value': '570', 'spread': '122', 'groupId': 'OG003'}, {'value': '973', 'spread': '64.6', 'groupId': 'OG004'}, {'value': '1330', 'spread': '61.9', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 23.917 hours (N=6,7,6,9,8,11)', 'categories': [{'measurements': [{'value': '201', 'spread': '71.7', 'groupId': 'OG000'}, {'value': '617', 'spread': '136', 'groupId': 'OG001'}, {'value': '1530', 'spread': '57.3', 'groupId': 'OG002'}, {'value': '276', 'spread': '186', 'groupId': 'OG003'}, {'value': '827', 'spread': '143', 'groupId': 'OG004'}, {'value': '1920', 'spread': '55.2', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 503.917 hours (N=6,7,5,9,8,8)', 'categories': [{'measurements': [{'value': '193', 'spread': '89.4', 'groupId': 'OG000'}, {'value': '712', 'spread': '308', 'groupId': 'OG001'}, {'value': '1310', 'spread': '218', 'groupId': 'OG002'}, {'value': '150', 'spread': '164', 'groupId': 'OG003'}, {'value': '385', 'spread': '123', 'groupId': 'OG004'}, {'value': '2730', 'spread': '285', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 649 hours (N=6,7,6,9,8,7)', 'categories': [{'measurements': [{'value': '394', 'spread': '89.4', 'groupId': 'OG000'}, {'value': '1230', 'spread': '193', 'groupId': 'OG001'}, {'value': '1160', 'spread': '234', 'groupId': 'OG002'}, {'value': '196', 'spread': '169', 'groupId': 'OG003'}, {'value': '473', 'spread': '132', 'groupId': 'OG004'}, {'value': '1470', 'spread': '249', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 652 hours (N=6,7,6,9,8,7)', 'categories': [{'measurements': [{'value': '699', 'spread': '53.9', 'groupId': 'OG000'}, {'value': '1940', 'spread': '144', 'groupId': 'OG001'}, {'value': '3360', 'spread': '105', 'groupId': 'OG002'}, {'value': '556', 'spread': '104', 'groupId': 'OG003'}, {'value': '1160', 'spread': '71.8', 'groupId': 'OG004'}, {'value': '2570', 'spread': '207', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 656 hours (N=5,7,6,8,8,6)', 'categories': [{'measurements': [{'value': '418', 'spread': '81.4', 'groupId': 'OG000'}, {'value': '1200', 'spread': '153', 'groupId': 'OG001'}, {'value': '1660', 'spread': '194', 'groupId': 'OG002'}, {'value': '243', 'spread': '135', 'groupId': 'OG003'}, {'value': '566', 'spread': '106', 'groupId': 'OG004'}, {'value': '1770', 'spread': '178', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 672 hours (N=4,7,5,-,6,6)', 'categories': [{'measurements': [{'value': '61.7', 'spread': '58.8', 'groupId': 'OG000'}, {'value': '84.8', 'spread': '490', 'groupId': 'OG001'}, {'value': '135', 'spread': '337', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Some patients had data below the limit of quantification which is not analysable and per internal rules, descriptive statistics are not calculated unless data from at least 2/3rds of all subjects were available.', 'groupId': 'OG003'}, {'value': '50.8', 'spread': '90.8', 'groupId': 'OG004'}, {'value': '123', 'spread': '297', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration', 'description': 'Plasma concentration time profiles of CD 6168', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 'Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'Cmax BI207127 in plasma (N=6,7,6,9,9,11)', 'categories': [{'measurements': [{'value': '2420', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '3490', 'spread': '61.7', 'groupId': 'OG001'}, {'value': '7440', 'spread': '81.8', 'groupId': 'OG002'}, {'value': '3590', 'spread': '64.1', 'groupId': 'OG003'}, {'value': '5910', 'spread': '54.3', 'groupId': 'OG004'}, {'value': '7640', 'spread': '52.5', 'groupId': 'OG005'}]}]}, {'title': 'Cmax CD 6168 in plasma (N=6,7,6,9,8,11)', 'categories': [{'measurements': [{'value': '261', 'spread': '56.2', 'groupId': 'OG000'}, {'value': '412', 'spread': '64.5', 'groupId': 'OG001'}, {'value': '891', 'spread': '51.0', 'groupId': 'OG002'}, {'value': '232', 'spread': '69.4', 'groupId': 'OG003'}, {'value': '426', 'spread': '75.5', 'groupId': 'OG004'}, {'value': '556', 'spread': '75.7', 'groupId': 'OG005'}]}]}, {'title': 'Cmax,ss BI207127 in plasma (N=6,7,6,9,9,7)', 'categories': [{'measurements': [{'value': '3260', 'spread': '70.1', 'groupId': 'OG000'}, {'value': '6020', 'spread': '91.5', 'groupId': 'OG001'}, {'value': '12200', 'spread': '73.0', 'groupId': 'OG002'}, {'value': '3460', 'spread': '55.2', 'groupId': 'OG003'}, {'value': '5750', 'spread': '67.2', 'groupId': 'OG004'}, {'value': '10800', 'spread': '66.0', 'groupId': 'OG005'}]}]}, {'title': 'Cmax,ss CD 6168 in plasma (N=6,7,6,9,8,7)', 'categories': [{'measurements': [{'value': '861', 'spread': '36.0', 'groupId': 'OG000'}, {'value': '2090', 'spread': '135', 'groupId': 'OG001'}, {'value': '3450', 'spread': '107', 'groupId': 'OG002'}, {'value': '584', 'spread': '105', 'groupId': 'OG003'}, {'value': '1170', 'spread': '74.0', 'groupId': 'OG004'}, {'value': '2990', 'spread': '122', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 'Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'tmax BI 207127 (N=6,7,6,9,9,11)', 'categories': [{'measurements': [{'value': '2.96', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '24.4', 'groupId': 'OG001'}, {'value': '3.91', 'spread': '24.9', 'groupId': 'OG002'}, {'value': '3.11', 'spread': '29.1', 'groupId': 'OG003'}, {'value': '3.19', 'spread': '31.7', 'groupId': 'OG004'}, {'value': '4.10', 'spread': '83.1', 'groupId': 'OG005'}]}]}, {'title': 'tmax CD 6168 (N=6,7,6,9,9,11)', 'categories': [{'measurements': [{'value': '4.79', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '4.80', 'spread': '28.2', 'groupId': 'OG001'}, {'value': '5.56', 'spread': '16.3', 'groupId': 'OG002'}, {'value': '4.82', 'spread': '26.1', 'groupId': 'OG003'}, {'value': '5.69', 'spread': '13.4', 'groupId': 'OG004'}, {'value': '5.37', 'spread': '23.0', 'groupId': 'OG005'}]}]}, {'title': 'tmax,ss BI 207127 (N=6,7,6,9,8,7)', 'categories': [{'measurements': [{'value': '2.57', 'spread': '108', 'groupId': 'OG000'}, {'value': '3.56', 'spread': '41.0', 'groupId': 'OG001'}, {'value': '3.32', 'spread': '16.5', 'groupId': 'OG002'}, {'value': '2.77', 'spread': '27.4', 'groupId': 'OG003'}, {'value': '3.26', 'spread': '24.5', 'groupId': 'OG004'}, {'value': '3.91', 'spread': '23.3', 'groupId': 'OG005'}]}]}, {'title': 'tmax,ss CD 6168(N=6,7,6,9,8,7)', 'categories': [{'measurements': [{'value': '3.24', 'spread': '68.0', 'groupId': 'OG000'}, {'value': '4.34', 'spread': '32.0', 'groupId': 'OG001'}, {'value': '3.91', 'spread': '24.0', 'groupId': 'OG002'}, {'value': '3.85', 'spread': '27.5', 'groupId': 'OG003'}, {'value': '3.63', 'spread': '24.6', 'groupId': 'OG004'}, {'value': '3.49', 'spread': '62.1', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'tmax \\[h\\] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state).', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 'AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'AUC0-6 BI 207127 (N=5,5,5,9,9,7)', 'categories': [{'measurements': [{'value': '8840', 'spread': '35.0', 'groupId': 'OG000'}, {'value': '13500', 'spread': '61.5', 'groupId': 'OG001'}, {'value': '23700', 'spread': '62.6', 'groupId': 'OG002'}, {'value': '13000', 'spread': '64.8', 'groupId': 'OG003'}, {'value': '21900', 'spread': '70.3', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG005'}]}]}, {'title': 'AUC0-6 CD 6168 (N=-,-,-,-,-,-)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG005'}]}]}, {'title': 'AUC0-6,ss BI 207127 (N=6,7,7,8,8,7)', 'categories': [{'measurements': [{'value': '11300', 'spread': '83.7', 'groupId': 'OG000'}, {'value': '24000', 'spread': '112', 'groupId': 'OG001'}, {'value': '42500', 'spread': '88.1', 'groupId': 'OG002'}, {'value': '12400', 'spread': '56.1', 'groupId': 'OG003'}, {'value': '21400', 'spread': '73.7', 'groupId': 'OG004'}, {'value': '36600', 'spread': '107', 'groupId': 'OG005'}]}]}, {'title': 'AUC0-6,ss CD 6168 (N=6,7,7,9,8,7)', 'categories': [{'measurements': [{'value': '3180', 'spread': '48.7', 'groupId': 'OG000'}, {'value': '9610', 'spread': '162', 'groupId': 'OG001'}, {'value': '14000', 'spread': '138', 'groupId': 'OG002'}, {'value': '2380', 'spread': '115', 'groupId': 'OG003'}, {'value': '4920', 'spread': '90.2', 'groupId': 'OG004'}, {'value': '12500', 'spread': '191', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28', 'description': 'Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 'Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'BI 207127 Cpre,1 (N=-,-,-,-,-,-)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 Cpre,2 (N=6,7,6,9,8,11)', 'categories': [{'measurements': [{'value': '595', 'spread': '72.0', 'groupId': 'OG000'}, {'value': '1610', 'spread': '138', 'groupId': 'OG001'}, {'value': '4780', 'spread': '76.4', 'groupId': 'OG002'}, {'value': '1170', 'spread': '201', 'groupId': 'OG003'}, {'value': '3450', 'spread': '173', 'groupId': 'OG004'}, {'value': '9350', 'spread': '71.0', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 Cpre,4 (N=5,6,6,9,9,10)', 'categories': [{'measurements': [{'value': '659', 'spread': '48.4', 'groupId': 'OG000'}, {'value': '1530', 'spread': '267', 'groupId': 'OG001'}, {'value': '6200', 'spread': '160', 'groupId': 'OG002'}, {'value': '816', 'spread': '197', 'groupId': 'OG003'}, {'value': '2780', 'spread': '201', 'groupId': 'OG004'}, {'value': '9830', 'spread': '170', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 Cpre,8 (N=6,6,5,9,9,9)', 'categories': [{'measurements': [{'value': '414', 'spread': '117', 'groupId': 'OG000'}, {'value': '607', 'spread': '131', 'groupId': 'OG001'}, {'value': '1770', 'spread': '310', 'groupId': 'OG002'}, {'value': '635', 'spread': '217', 'groupId': 'OG003'}, {'value': '783', 'spread': '186', 'groupId': 'OG004'}, {'value': '4160', 'spread': '176', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 Cpre,15 (N=6,7,6,9,8,8)', 'categories': [{'measurements': [{'value': '399', 'spread': '135', 'groupId': 'OG000'}, {'value': '1170', 'spread': '188', 'groupId': 'OG001'}, {'value': '1560', 'spread': '139', 'groupId': 'OG002'}, {'value': '358', 'spread': '97.8', 'groupId': 'OG003'}, {'value': '944', 'spread': '163', 'groupId': 'OG004'}, {'value': '3530', 'spread': '349', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 Cpre,22 (N=6,7,6,9,8,8)', 'categories': [{'measurements': [{'value': '336', 'spread': '101', 'groupId': 'OG000'}, {'value': '1250', 'spread': '302', 'groupId': 'OG001'}, {'value': '1340', 'spread': '165', 'groupId': 'OG002'}, {'value': '330', 'spread': '104', 'groupId': 'OG003'}, {'value': '709', 'spread': '167', 'groupId': 'OG004'}, {'value': '4460', 'spread': '249', 'groupId': 'OG005'}]}]}, {'title': 'BI 207127 Cpre,27 (N=-,5,-,6,-,-)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG000'}, {'value': '4270', 'spread': '56.9', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG002'}, {'value': '1280', 'spread': '80.8', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 Cpre,1 (N=-,-,-,-,-,-)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 Cpre,2 (N=6,7,6,9,8,11)', 'categories': [{'measurements': [{'value': '201', 'spread': '71.7', 'groupId': 'OG000'}, {'value': '617', 'spread': '136', 'groupId': 'OG001'}, {'value': '1530', 'spread': '57.3', 'groupId': 'OG002'}, {'value': '276', 'spread': '186', 'groupId': 'OG003'}, {'value': '827', 'spread': '143', 'groupId': 'OG004'}, {'value': '1920', 'spread': '55.2', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 Cpre,4 (N=5,6,6,9,9,10)', 'categories': [{'measurements': [{'value': '236', 'spread': '56.2', 'groupId': 'OG000'}, {'value': '564', 'spread': '276', 'groupId': 'OG001'}, {'value': '2510', 'spread': '146', 'groupId': 'OG002'}, {'value': '250', 'spread': '257', 'groupId': 'OG003'}, {'value': '994', 'spread': '192', 'groupId': 'OG004'}, {'value': '3000', 'spread': '235', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 Cpre,8 (N=6,6,5,9,9,9)', 'categories': [{'measurements': [{'value': '194', 'spread': '111', 'groupId': 'OG000'}, {'value': '368', 'spread': '138', 'groupId': 'OG001'}, {'value': '1140', 'spread': '177', 'groupId': 'OG002'}, {'value': '253', 'spread': '353', 'groupId': 'OG003'}, {'value': '350', 'spread': '221', 'groupId': 'OG004'}, {'value': '2340', 'spread': '183', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 Cpre,15 (N=6,7,6,9,8,8)', 'categories': [{'measurements': [{'value': '239', 'spread': '175', 'groupId': 'OG000'}, {'value': '723', 'spread': '265', 'groupId': 'OG001'}, {'value': '1000', 'spread': '149', 'groupId': 'OG002'}, {'value': '169', 'spread': '172', 'groupId': 'OG003'}, {'value': '428', 'spread': '135', 'groupId': 'OG004'}, {'value': '2020', 'spread': '519', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 Cpre,22 (N=6,7,6,9,8,8)', 'categories': [{'measurements': [{'value': '193', 'spread': '89.4', 'groupId': 'OG000'}, {'value': '712', 'spread': '308', 'groupId': 'OG001'}, {'value': '1010', 'spread': '226', 'groupId': 'OG002'}, {'value': '150', 'spread': '164', 'groupId': 'OG003'}, {'value': '385', 'spread': '123', 'groupId': 'OG004'}, {'value': '2730', 'spread': '285', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 Cpre,27 (N=-,5,-,6,-,-)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG000'}, {'value': '1730', 'spread': '74.5', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG002'}, {'value': '427', 'spread': '147', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No descriptive statistics calculated. Per internal rules descriptive statistics were calculated only if at least 2/3 plasma concentrations were available.', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27', 'description': 'Cpre,N \\[ng/mL\\] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 'C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'BI 207127 654 hours', 'categories': [{'measurements': [{'value': '1520', 'spread': '103', 'groupId': 'OG000'}, {'value': '4030', 'spread': '107', 'groupId': 'OG001'}, {'value': '5820', 'spread': '94.4', 'groupId': 'OG002'}, {'value': '1380', 'spread': '71.4', 'groupId': 'OG003'}, {'value': '2810', 'spread': '85.7', 'groupId': 'OG004'}, {'value': '5910', 'spread': '114', 'groupId': 'OG005'}]}]}, {'title': 'CD 6168 654 hours', 'categories': [{'measurements': [{'value': '556', 'spread': '63.7', 'groupId': 'OG000'}, {'value': '1810', 'spread': '148', 'groupId': 'OG001'}, {'value': '2580', 'spread': '136', 'groupId': 'OG002'}, {'value': '424', 'spread': '122', 'groupId': 'OG003'}, {'value': '893', 'spread': '89.7', 'groupId': 'OG004'}, {'value': '2200', 'spread': '133', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '654 hours after drug administration on day 28', 'description': 'C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 'AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'AUC0 to infinity,SS of BI207127', 'categories': [{'measurements': [{'value': '20500', 'spread': '88.4', 'groupId': 'OG000'}, {'value': '38600', 'spread': '131', 'groupId': 'OG001'}, {'value': '62300', 'spread': '99.2', 'groupId': 'OG002'}, {'value': '16900', 'spread': '63.0', 'groupId': 'OG003'}, {'value': '31500', 'spread': '79.2', 'groupId': 'OG004'}, {'value': '71300', 'spread': '116', 'groupId': 'OG005'}]}]}, {'title': 'AUC0 to infinity,SS of CD 6168', 'categories': [{'measurements': [{'value': '7170', 'spread': '70.9', 'groupId': 'OG000'}, {'value': '19600', 'spread': '201', 'groupId': 'OG001'}, {'value': '26800', 'spread': '171', 'groupId': 'OG002'}, {'value': '4290', 'spread': '129', 'groupId': 'OG003'}, {'value': '9190', 'spread': '97.9', 'groupId': 'OG004'}, {'value': '29000', 'spread': '196', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 'λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'λz,ss of BI 207127', 'categories': [{'measurements': [{'value': '0.162', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '0.182', 'spread': '27.8', 'groupId': 'OG001'}, {'value': '0.170', 'spread': '32.6', 'groupId': 'OG002'}, {'value': '0.226', 'spread': '20.8', 'groupId': 'OG003'}, {'value': '0.163', 'spread': '30.9', 'groupId': 'OG004'}, {'value': '0.174', 'spread': '28.2', 'groupId': 'OG005'}]}]}, {'title': 'λz,ss of CD 6168', 'categories': [{'measurements': [{'value': '0.157', 'spread': '36.4', 'groupId': 'OG000'}, {'value': '0.163', 'spread': '20.3', 'groupId': 'OG001'}, {'value': '0.166', 'spread': '43.3', 'groupId': 'OG002'}, {'value': '0.185', 'spread': '21.4', 'groupId': 'OG003'}, {'value': '0.192', 'spread': '24.3', 'groupId': 'OG004'}, {'value': '0.129', 'spread': '56.0', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose', 'unitOfMeasure': '1/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 't1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 't1/2,ss of BI 207127', 'categories': [{'measurements': [{'value': '4.28', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '3.81', 'spread': '27.8', 'groupId': 'OG001'}, {'value': '4.09', 'spread': '32.6', 'groupId': 'OG002'}, {'value': '3.06', 'spread': '20.8', 'groupId': 'OG003'}, {'value': '4.26', 'spread': '30.9', 'groupId': 'OG004'}, {'value': '3.99', 'spread': '28.2', 'groupId': 'OG005'}]}]}, {'title': 'MRTpo,ss of BI 207127', 'categories': [{'measurements': [{'value': '6.44', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '6.40', 'spread': '17.7', 'groupId': 'OG001'}, {'value': '5.83', 'spread': '14.5', 'groupId': 'OG002'}, {'value': '5.32', 'spread': '16.8', 'groupId': 'OG003'}, {'value': '5.82', 'spread': '12.9', 'groupId': 'OG004'}, {'value': '7.03', 'spread': '23.8', 'groupId': 'OG005'}]}]}, {'title': 't1/2,ss of CD 6168', 'categories': [{'measurements': [{'value': '4.42', 'spread': '36.4', 'groupId': 'OG000'}, {'value': '4.25', 'spread': '20.3', 'groupId': 'OG001'}, {'value': '4.18', 'spread': '43.3', 'groupId': 'OG002'}, {'value': '3.75', 'spread': '21.4', 'groupId': 'OG003'}, {'value': '3.61', 'spread': '24.3', 'groupId': 'OG004'}, {'value': '5.36', 'spread': '56.0', 'groupId': 'OG005'}]}]}, {'title': 'MRTpo,ss of CD 6168', 'categories': [{'measurements': [{'value': '8.98', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '8.61', 'spread': '24.7', 'groupId': 'OG001'}, {'value': '8.07', 'spread': '22.5', 'groupId': 'OG002'}, {'value': '7.51', 'spread': '14.2', 'groupId': 'OG003'}, {'value': '7.75', 'spread': '16.4', 'groupId': 'OG004'}, {'value': '9.38', 'spread': '30.8', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 'RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'RA,Cmax of BI 207127', 'categories': [{'measurements': [{'value': '1.35', 'spread': '74.1', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '95.2', 'groupId': 'OG001'}, {'value': '1.64', 'spread': '84.4', 'groupId': 'OG002'}, {'value': '0.965', 'spread': '37.5', 'groupId': 'OG003'}, {'value': '1.02', 'spread': '40.0', 'groupId': 'OG004'}, {'value': '1.44', 'spread': '56.2', 'groupId': 'OG005'}]}]}, {'title': 'RA,Cmax of CD 6168', 'categories': [{'measurements': [{'value': '3.30', 'spread': '66.5', 'groupId': 'OG000'}, {'value': '5.07', 'spread': '127', 'groupId': 'OG001'}, {'value': '3.87', 'spread': '120', 'groupId': 'OG002'}, {'value': '2.52', 'spread': '84.8', 'groupId': 'OG003'}, {'value': '2.77', 'spread': '55.9', 'groupId': 'OG004'}, {'value': '6.08', 'spread': '146', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'BI 207127 400 mg', 'description': 'Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'BI 207127 600 mg', 'description': 'Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'BI 207127 800 mg', 'description': 'Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'title': 'Weight decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of the study to Day 30 (2 days after last dose)', 'description': 'Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Discontinuations Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG001', 'title': 'BI 207127 400 mg', 'description': 'Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG002', 'title': 'BI 207127 600 mg', 'description': 'Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'OG003', 'title': 'BI 207127 800 mg', 'description': 'Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Number of participants with adverse events (AEs) leading to discontinuation of trial drug', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'Treatment Naive (TN) patients to receive Placebo (given as a tablet, orally three times daily (tid)) + Peg-IFN (Peginterferon alfa (Peg-IFN) injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days'}, {'id': 'FG001', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days'}, {'id': 'FG002', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days'}, {'id': 'FG003', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days'}, {'id': 'FG004', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'Treatment Experienced (TE) patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days'}, {'id': 'FG005', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days'}, {'id': 'FG006', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '75 patients were screened, however only 57 patients were randomised.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '57', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'BG001', 'title': 'Treatment Naive (TN): BI 207127 400 mg', 'description': 'TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'BG002', 'title': 'Treatment Naive (TN): BI 207127 600 mg', 'description': 'TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'BG003', 'title': 'Treatment Naive (TN): BI 207127 800 mg', 'description': 'TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'BG004', 'title': 'Treatment Experienced (TE): BI 207127 400 mg', 'description': 'TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'BG005', 'title': 'Treatment Experienced (TE): BI 207127 600 mg', 'description': 'TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'BG006', 'title': 'Treatment Experienced (TE): BI 207127 800 mg', 'description': 'TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.250', 'spread': '7.573', 'groupId': 'BG000'}, {'value': '43.833', 'spread': '15.459', 'groupId': 'BG001'}, {'value': '42.571', 'spread': '11.731', 'groupId': 'BG002'}, {'value': '46.167', 'spread': '13.963', 'groupId': 'BG003'}, {'value': '49.200', 'spread': '5.996', 'groupId': 'BG004'}, {'value': '50.889', 'spread': '11.252', 'groupId': 'BG005'}, {'value': '53.727', 'spread': '10.287', 'groupId': 'BG006'}, {'value': '48.930', 'spread': '10.863', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '47', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS): All patients who received at least one dose of study medication'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-03-17', 'studyFirstSubmitDate': '2009-05-19', 'resultsFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-17', 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The primary efficacy endpoint is the number of participants with virologic response defined as \\>= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as \\>= 1 log increase in viral load from nadir.'}], 'secondaryOutcomes': [{'measure': 'Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline', 'timeFrame': 'Baseline and days 1, 2, 4, 8, 15, 22 and 28', 'description': 'Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit.\n\nA negative value represents an increase in viral load, a positive value represents a decrease in viral load.'}, {'measure': 'Viral Load at Each Visit up to Day 28', 'timeFrame': 'Baseline and days 8, 15, 22 and 28', 'description': 'Viral load (VL) (original values) at each visit up to day 28.'}, {'measure': 'Number of Participants With Virologic Response at Day 28', 'timeFrame': 'day 28', 'description': 'Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), \\<10 IU/mL, at day 28'}, {'measure': 'Number of Participants With Rapid Virological Response', 'timeFrame': '4 weeks', 'description': 'Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28.'}, {'measure': 'Number of Participants With Early Virological Response', 'timeFrame': 'Baseline and week 12', 'description': 'Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders\\* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84)'}, {'measure': 'Number of Participants With End of Treatment Response', 'timeFrame': 'Week 12', 'description': 'Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders\\* - Response = Viral load below the limit of detection at end of all treatment.'}, {'measure': 'Number of Participants With Sustained Virological Response', 'timeFrame': 'Until end of treatment, up to 570 days', 'description': 'Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (\\<10 IU/mL) at least 85 days after stopping standard care (SOC).'}, {'measure': 'Plasma Concentration Time Profiles of BI 207127', 'timeFrame': '0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration', 'description': 'Plasma concentration time profiles of BI 207127'}, {'measure': 'Plasma Concentration Time Profiles of CD 6168', 'timeFrame': '0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration', 'description': 'Plasma concentration time profiles of CD 6168'}, {'measure': 'Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)', 'timeFrame': '5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168'}, {'measure': 'Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)', 'timeFrame': '5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'tmax \\[h\\] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state).'}, {'measure': 'AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)', 'timeFrame': '30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28', 'description': 'Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168'}, {'measure': 'Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168', 'timeFrame': '5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27', 'description': 'Cpre,N \\[ng/mL\\] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below.'}, {'measure': 'C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose', 'timeFrame': '654 hours after drug administration on day 28', 'description': 'C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h).'}, {'measure': 'AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose', 'timeFrame': '5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose'}, {'measure': 'λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose', 'timeFrame': '5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose'}, {'measure': 't1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose', 'timeFrame': '5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose'}, {'measure': 'RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose', 'timeFrame': '5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28', 'description': 'Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax.'}, {'measure': 'Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG', 'timeFrame': 'From the start of the study to Day 30 (2 days after last dose)', 'description': 'Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events.'}, {'measure': 'Number of Participants With Discontinuations Due to AEs', 'timeFrame': '4 weeks', 'description': 'Number of participants with adverse events (AEs) leading to discontinuation of trial drug'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '22414766', 'type': 'DERIVED', 'citation': 'Larrey D, Lohse AW, de Ledinghen V, Trepo C, Gerlach T, Zarski JP, Tran A, Mathurin P, Thimme R, Arasteh K, Trautwein C, Cerny A, Dikopoulos N, Schuchmann M, Heim MH, Gerken G, Stern JO, Wu K, Abdallah N, Girlich B, Scherer J, Berger F, Marquis M, Kukolj G, Bocher W, Steffgen J. Rapid and strong antiviral activity of the non-nucleosidic NS5B polymerase inhibitor BI 207127 in combination with peginterferon alfa 2a and ribavirin. J Hepatol. 2012 Jul;57(1):39-46. doi: 10.1016/j.jhep.2012.02.015. Epub 2012 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. HCV genotype 1\n2. HCV viral load \\>100,000 IU/mL\n3. histology or fibroscan to rule out cirrhosis\n4. Absence of retinopathy\n5. treatment naive patients and treatment experienced patients\n6. Age 18 - 70 years\n7. Male OR female with documented hysterectomy OR postmenopausal\n\nExclusion criteria:\n\n1. Fertile males not willing to use an adequate form of contraception\n2. Pretreatment with any HCV-polymerase inhibitor\n3. Any concurrent disease if clinically significant based on the investigator's medical assessment\n4. Current alcohol or drug abuse, or history of the same\n5. Positive test for HIV or HBs\n6. History of malignancy\n7. Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination\n8. Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer\n9. Any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening\n10. Patients treated with any interferon (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening\n11. Known hypersensitivity to drugs or excipients; Further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT00905632', 'briefTitle': '4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study', 'orgStudyIdInfo': {'id': '1241.7'}, 'secondaryIdInfos': [{'id': '2008-008292-34', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 207127 low dose + SOC', 'description': 'BI 207127 low dose tid + SOC', 'interventionNames': ['Drug: BI 207127 low dose + SOC']}, {'type': 'EXPERIMENTAL', 'label': 'BI 207127 middle dose +SOC', 'description': 'BI 207127 middle dose tid + SOC', 'interventionNames': ['Drug: BI 207127 middle dose +SOC']}, {'type': 'EXPERIMENTAL', 'label': 'BI 207127 high dose+SOC', 'description': 'BI 207127 high dose tid +SOC', 'interventionNames': ['Drug: BI 207127 high dose+SOC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + SOC', 'description': 'Placebo tid +SOC', 'interventionNames': ['Drug: Placebo + SOC']}], 'interventions': [{'name': 'BI 207127 middle dose +SOC', 'type': 'DRUG', 'description': 'BI 207127 middle dose tid + SOC', 'armGroupLabels': ['BI 207127 middle dose +SOC']}, {'name': 'BI 207127 high dose+SOC', 'type': 'DRUG', 'description': 'BI 207127 high dose tid +SOC', 'armGroupLabels': ['BI 207127 high dose+SOC']}, {'name': 'Placebo + SOC', 'type': 'DRUG', 'description': 'Placebo tid +SOC', 'armGroupLabels': ['Placebo + SOC']}, {'name': 'BI 207127 low dose + SOC', 'type': 'DRUG', 'description': 'BI 207127 low dose tid + SOC', 'armGroupLabels': ['BI 207127 low dose + SOC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble Cédex 9', 'country': 'France', 'facility': '1241.7.3307A CHU de Grenoble'}, {'city': 'Lille', 'country': 'France', 'facility': '1241.7.3303A Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': "1241.7.3302A Hopital de l'Hotel Dieu", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montpellier', 'country': 'France', 'facility': '1241.7.3301A Hôpital Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nice', 'country': 'France', 'facility': '1241.7.3305A HOP Archet 2', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Pessac', 'country': 'France', 'facility': '1241.7.3306A Hôpital Haut-Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': '1241.7.3304A HOP de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'city': 'Aachen', 'country': 'Germany', 'facility': '1241.7.49010 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Berlin', 'country': 'Germany', 'facility': '1241.7.49012 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Essen', 'country': 'Germany', 'facility': '1241.7.49004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': '1241.7.49011 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': '1241.7.49001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Mainz', 'country': 'Germany', 'facility': '1241.7.49013 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Regensburg', 'country': 'Germany', 'facility': '1241.7.49009 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Ulm', 'country': 'Germany', 'facility': '1241.7.49002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': '1241.7.41003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Lugano', 'country': 'Switzerland', 'facility': '1241.7.41004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': '1241.7.41001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Boehringer Ingelheim, Study Chair', 'oldOrganization': 'Boehringer Ingelheim'}}}}