Viewing Study NCT00983957

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Ignite Creation Date: 2025-12-24 @ 6:49 PM
Ignite Modification Date: 2026-02-25 @ 7:02 PM
Study NCT ID: NCT00983957
Status: COMPLETED
Last Update Posted: 2015-10-16
First Post: 2009-09-23
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'C549273', 'term': 'daclatasvir'}, {'id': 'C109079', 'term': 'norgestimate, ethinyl estradiol drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@bms.com', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb International Corporation'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of treatment (Day 1) up to Day 78 or discharge', 'description': 'On-Treatment Period', 'eventGroups': [{'id': 'EG000', 'title': 'All Treated Participants', 'description': 'Participants received sequentially Treatment A: Ortho Tri-Cyclen (OTC) fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 along with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.', 'otherNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ortho Tri-Cyclen Days 1-28', 'description': 'Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28.', 'otherNumAtRisk': 20, 'otherNumAffected': 8, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ortho Tri-Cyclen Days 29-46', 'description': 'Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 46.', 'otherNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ortho Tri-Cyclen Days 47-56', 'description': 'Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 47 to 56.', 'otherNumAtRisk': 20, 'otherNumAffected': 7, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Ortho Tri-Cyclen Days 57-67', 'description': 'Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67.', 'otherNumAtRisk': 18, 'otherNumAffected': 5, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Ortho Tri-Cyclen + Daclatasvir Days 68-77', 'description': 'Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67 along with daclatasvir two tablets of 30-mg, orally, once daily from Day 68 to 77.', 'otherNumAtRisk': 18, 'otherNumAffected': 12, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Procedural dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '118.53', 'spread': '34', 'groupId': 'OG000'}, {'value': '134.70', 'spread': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.105', 'ciLowerLimit': '1.023', 'ciUpperLimit': '1.195', 'estimateComment': 'Point estimates and 90% Confidence Interval (CIs) for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.', 'groupDescription': 'Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77', 'description': 'Ethinyl Estradiol is an analyte of Ortho Tri-Cyclen. Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.', 'unitOfMeasure': 'picogram per millilitre (pg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study drug.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration of Norgestrel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '2674.69', 'spread': '32', 'groupId': 'OG000'}, {'value': '2815.98', 'spread': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.071', 'ciLowerLimit': '0.988', 'ciUpperLimit': '1.160', 'estimateComment': 'Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.', 'groupDescription': 'Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norgestrel is an NGM metabolite and was measured in plasma using liquid chromatography-mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study drug.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '959.37', 'spread': '38', 'groupId': 'OG000'}, {'value': '994.40', 'spread': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.009', 'ciLowerLimit': '0.951', 'ciUpperLimit': '1.070', 'estimateComment': 'Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.', 'groupDescription': 'Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg\\*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.', 'unitOfMeasure': 'pg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study drug.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '47258.35', 'spread': '38', 'groupId': 'OG000'}, {'value': '51760.43', 'spread': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.121', 'ciLowerLimit': '1.018', 'ciUpperLimit': '1.234', 'estimateComment': 'Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.', 'groupDescription': 'Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg\\*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.', 'unitOfMeasure': 'pg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study drug.'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Observed Plasma Concentration of Norgestrel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study drug.'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study drug'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration of Norelgestromin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '20', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.059', 'ciLowerLimit': '0.988', 'ciUpperLimit': '1.135', 'estimateComment': 'Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.', 'groupDescription': 'Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norelgestromin is a major active metabolite of norgestimate (NGM) which is found in Ortho Tri-Cyclen. Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.', 'unitOfMeasure': 'nanogram per millilitre (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AE Leading to Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For AEs from start of treatment (Day 1) up to Day 78 or discharge and for SAEs from Day 1 to 30 days after last dose of study drug', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'title': 'Hematocrit', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood in Urine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment (Day 1) up to Day 78 or discharge', 'description': 'Laboratory marked abnormalities were defined as Hematocrit (low) as \\<0.85\\*Pre-treatment (PreRx), Hemoglobin (low) as \\<0.85\\*PreRx, Aspartate Aminotransferase (AST) (high) as \\>1.25\\*PreRx if PreRx \\> upper limits of normal (ULN); \\>1.25\\*ULN if PreRx \\<=ULN; \\>1.25\\*ULN if PreRx = Missing, Blood in urine (high) as ≥2 PreRx if PreRx ≥1; ≥2 if PreRx \\<1; ≥2 if PreRx = Missing.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 28, Day 29, Day 67, Day 68, Day 78, Day of discharge', 'description': 'Vital Signs were measured after the participant was seated quietly for at least 5 minutes and included systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature. Baseline = Last non-missing pretreatment value.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, Day 1, Day 67, Day 77', 'description': 'The electrocardiogram (ECG) evaluations were performed within ± 15 minutes of the relative time points. ECGs were recorded after the participants were in supine position for at least 5 minutes. ECG parameters measured were: PR interval, QRS complex, QT interval and corrected QT (QTc).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.38', 'spread': '24', 'groupId': 'OG000'}, {'value': '16.84', 'spread': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.115', 'ciLowerLimit': '1.063', 'ciUpperLimit': '1.171', 'estimateComment': 'Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.', 'groupDescription': 'Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in nanograms multiplied by hours (h) per milliliter (ng\\*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study drug.'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Observed Plasma Concentration of Norelgestromin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho Tri-Cyclen', 'description': 'Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.'}, {'id': 'OG001', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Treatment A', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Treatment B', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Treatment C', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 47 participants were enrolled; 20 were treated. Reasons 27 participants were not treated: 21 no longer met study criteria, 2 withdrew consent, and 4 other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ortho Tri-Cyclen + Daclatasvir', 'description': 'Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '7.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<= 45 years', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-16', 'studyFirstSubmitDate': '2009-09-23', 'resultsFirstSubmitDate': '2015-08-18', 'studyFirstSubmitQcDate': '2009-09-23', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-18', 'studyFirstPostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77', 'description': 'Ethinyl Estradiol is an analyte of Ortho Tri-Cyclen. Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.'}, {'measure': 'Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg\\*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.'}, {'measure': 'Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.'}, {'measure': 'Maximum Observed Plasma Concentration of Norelgestromin', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norelgestromin is a major active metabolite of norgestimate (NGM) which is found in Ortho Tri-Cyclen. Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.'}, {'measure': 'Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in nanograms multiplied by hours (h) per milliliter (ng\\*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.'}, {'measure': 'Time of Maximum Observed Plasma Concentration of Norelgestromin', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration of Norgestrel', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norgestrel is an NGM metabolite and was measured in plasma using liquid chromatography-mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.'}, {'measure': 'Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg\\*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.'}, {'measure': 'Time of Maximum Observed Plasma Concentration of Norgestrel', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77', 'description': 'Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died', 'timeFrame': 'For AEs from start of treatment (Day 1) up to Day 78 or discharge and for SAEs from Day 1 to 30 days after last dose of study drug', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'From start of treatment (Day 1) up to Day 78 or discharge', 'description': 'Laboratory marked abnormalities were defined as Hematocrit (low) as \\<0.85\\*Pre-treatment (PreRx), Hemoglobin (low) as \\<0.85\\*PreRx, Aspartate Aminotransferase (AST) (high) as \\>1.25\\*PreRx if PreRx \\> upper limits of normal (ULN); \\>1.25\\*ULN if PreRx \\<=ULN; \\>1.25\\*ULN if PreRx = Missing, Blood in urine (high) as ≥2 PreRx if PreRx ≥1; ≥2 if PreRx \\<1; ≥2 if PreRx = Missing.'}, {'measure': 'Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs', 'timeFrame': 'Baseline, Day 28, Day 29, Day 67, Day 68, Day 78, Day of discharge', 'description': 'Vital Signs were measured after the participant was seated quietly for at least 5 minutes and included systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature. Baseline = Last non-missing pretreatment value.'}, {'measure': 'Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters', 'timeFrame': 'Screening, Day 1, Day 67, Day 77', 'description': 'The electrocardiogram (ECG) evaluations were performed within ± 15 minutes of the relative time points. ECGs were recorded after the participants were in supine position for at least 5 minutes. ECG parameters measured were: PR interval, QRS complex, QT interval and corrected QT (QTc).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Healthy female subjects, 18-45 years, BMI 18-32 kg/m².\n* Must be using an adequate method of contraception to avoid pregnancy throughout the study.\n\nKey Exclusion Criteria:\n\n* Abnormal Pap smear within 1 yr of dosing, and abnormal menstrual cycle during the 3 months prior to enrollment.\n* Any significant or chronic uncontrolled medical illness.'}, 'identificationModule': {'nctId': 'NCT00983957', 'briefTitle': 'Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'The Effect of the Co-administration of BMS-790052 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri-Cyclen®) in Healthy Female Subjects', 'orgStudyIdInfo': {'id': 'AI444-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-790052 plus Ortho Tri-Cyclen®', 'interventionNames': ['Drug: BMS-790052', 'Drug: Ortho Tri-Cyclen®']}], 'interventions': [{'name': 'BMS-790052', 'type': 'DRUG', 'description': 'Tablets, Oral, 60 mg, once daily, 10 days', 'armGroupLabels': ['BMS-790052 plus Ortho Tri-Cyclen®']}, {'name': 'Ortho Tri-Cyclen®', 'type': 'DRUG', 'description': 'Tablets, Oral, once daily, 78 days', 'armGroupLabels': ['BMS-790052 plus Ortho Tri-Cyclen®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'MDS Pharma Services (US), Inc', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '78752', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Clinical Research Unit, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': 'H4R2N6', 'city': 'Saint-Laurent', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.50008, 'lon': -73.66585}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}