Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT01016912
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2009-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@bms.com', 'title': 'BristolMyers 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 baseline up to 30 days after last dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo+pegIFNα +Ribavirin (Treatment Naive)', 'description': 'Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon IFNα containing regimens including pegIFNα-2b/ribavirin.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Daclatasvir 10- mg+pegIFNα+Ribavirin (Treatment Naive)', 'description': 'Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Daclatasvir 60- mg+pegIFNα+Ribavirin (Treatment Naive)', 'description': 'Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Daclatasvir 10- mg+pegIFNα+Ribavirin (Non--Responders)', 'description': 'Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Daclatasvir 60- mg+pegIFNα+Ribavirin (Non--Responders)', 'description': 'Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Amenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Prurigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Temporomandibular joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 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'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': "Basedow's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 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'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retinal exudates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Heat rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sputum retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vessel puncture site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG001', 'title': 'Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG002', 'title': 'Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..'}, {'id': 'OG003', 'title': 'Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.'}, {'id': 'OG004', 'title': 'Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Discontinuation due to AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 30 days after last dose of study drug', 'description': 'AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study therapy.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..'}, {'id': 'OG001', 'title': 'Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..'}, {'id': 'OG002', 'title': 'Daclatasvir 60- mg + pegIFNα- + Ribavirin (Treatment-naive)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG003', 'title': 'Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.'}, {'id': 'OG004', 'title': 'Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.'}], 'classes': [{'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'WBC', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'ALT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Total bilirubin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 30 days after last dose of study drug', 'description': 'Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= \\<7.0 to 8.9 g/dL, Grade 4= \\<7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm\\^3, Grade 4= \\<350 cells/mm\\^3. Neutrophils: Grade 3= 500-999 cells/mm\\^3, Grade 4= \\<500 cells/mm\\^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm\\^3, Grade 4= \\<1000 cells/mm\\^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10\\*upper limit of normal (ULN), Grade 4= \\>10.0\\*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10\\*ULN, Grade 4= \\>10.0\\*ULN. Total bilirubin: Grade 3= 2.6-5\\*ULN, Grade 4= \\>5.0\\*ULN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study therapy.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Extended Rapid Virologic Response (eRVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG001', 'title': 'Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin'}, {'id': 'OG002', 'title': 'Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment Naive)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG003', 'title': 'Daclatasvir 10- mg + pegINFα + Ribavirin (Nonresponders)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.'}, {'id': 'OG004', 'title': 'Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '25.0'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '87.1'}, {'value': '80.0', 'groupId': 'OG002', 'lowerLimit': '55.0', 'upperLimit': '94.5'}, {'value': '55.6', 'groupId': 'OG003', 'lowerLimit': '30.1', 'upperLimit': '79.0'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '6.1', 'upperLimit': '49.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Weeks 4 and 12 on treatment', 'description': 'eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \\<15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Rapid Virologic Response (RVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin'}, {'id': 'OG001', 'title': 'Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG002', 'title': 'Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG003', 'title': 'Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin..'}, {'id': 'OG004', 'title': 'Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '25.0'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '51.0', 'upperLimit': '93.9'}, {'value': '80.0', 'groupId': 'OG002', 'lowerLimit': '55.0', 'upperLimit': '94.5'}, {'value': '55.6', 'groupId': 'OG003', 'lowerLimit': '30.1', 'upperLimit': '79.0'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '12.9', 'upperLimit': '59.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4 on treatment', 'description': 'RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \\<15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Early Virologic Response (cEVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG001', 'title': 'Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG002', 'title': 'Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG003', 'title': 'Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonreponders)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.'}, {'id': 'OG004', 'title': 'Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '34.5', 'upperLimit': '85.3'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '51.0', 'upperLimit': '93.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '79.4', 'upperLimit': '100.0'}, {'value': '55.6', 'groupId': 'OG003', 'lowerLimit': '30.1', 'upperLimit': '79.0'}, {'value': '55.6', 'groupId': 'OG004', 'lowerLimit': '30.1', 'upperLimit': '79.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12 on treatment', 'description': 'cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \\<15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG001', 'title': 'Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG002', 'title': 'Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG003', 'title': 'Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.'}, {'id': 'OG004', 'title': 'Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin'}], 'classes': [{'title': 'SVR4: Follow-up Week 4', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '46.2', 'upperLimit': '93.1'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '87.1'}, {'value': '90.0', 'groupId': 'OG002', 'lowerLimit': '66.3', 'upperLimit': '99.0'}, {'value': '22.2', 'groupId': 'OG003', 'lowerLimit': '6.1', 'upperLimit': '49.0'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '12.9', 'upperLimit': '59.9'}]}]}, {'title': 'SVR12: Follow-up Week 12', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '34.5', 'upperLimit': '85.3'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '87.1'}, {'value': '90.0', 'groupId': 'OG002', 'lowerLimit': '66.3', 'upperLimit': '99.0'}, {'value': '22.2', 'groupId': 'OG003', 'lowerLimit': '6.1', 'upperLimit': '49.0'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '12.9', 'upperLimit': '59.9'}]}]}, {'title': 'SVR24: Follow-up Week 24', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '34.5', 'upperLimit': '85.3'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '40.1', 'upperLimit': '87.1'}, {'value': '90.0', 'groupId': 'OG002', 'lowerLimit': '66.3', 'upperLimit': '99.0'}, {'value': '22.2', 'groupId': 'OG003', 'lowerLimit': '6.1', 'upperLimit': '49.0'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '12.9', 'upperLimit': '59.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up Weeks 4, 12, and 24', 'description': 'SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \\<15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin'}, {'id': 'OG001', 'title': 'Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin'}, {'id': 'OG002', 'title': 'Daclatasvir 60 mg + Peg-IFNα + Ribavirin (Treatment-naive)', 'description': 'received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'OG003', 'title': 'Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.'}, {'id': 'OG004', 'title': 'Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.'}], 'classes': [{'title': 'Virologic failure', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}, {'value': '77.8', 'groupId': 'OG003'}, {'value': '66.7', 'groupId': 'OG004'}]}]}, {'title': 'Virologic breakthrough', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '44.4', 'groupId': 'OG003'}, {'value': '44.4', 'groupId': 'OG004'}]}]}, {'title': 'Relapse', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '22.2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From on-treatment Week 1 to Follow-up Week 24', 'description': 'Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed \\>1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. \\<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as \\<2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study therapy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'FG001', 'title': 'Daclatasvir 10- mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'FG002', 'title': 'Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'FG003', 'title': 'Daclatasvir 10- mg + pegIFNα+ Ribavirin (Nonresponders)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.'}, {'id': 'FG004', 'title': 'Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.'}], 'periods': [{'title': 'End of Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Completed double-blind period only', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'comment': 'Those who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment', 'groupId': 'FG001', 'numSubjects': '9'}, {'comment': 'Those who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment', 'groupId': 'FG002', 'numSubjects': '10'}, {'comment': 'Those who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment', 'groupId': 'FG003', 'numSubjects': '9'}, {'comment': 'Those who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment', 'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 6 sites in Japan.', 'preAssignmentDetails': 'A total of 51 participants were enrolled, of which 45 were randomized to receive treatment and 6 were discontinued for no longer meeting study criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'BG001', 'title': 'Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'BG002', 'title': 'Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.'}, {'id': 'BG003', 'title': 'Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.'}, {'id': 'BG004', 'title': 'Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders)', 'description': 'Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '8.78', 'groupId': 'BG000'}, {'value': '49.1', 'spread': '15.09', 'groupId': 'BG001'}, {'value': '53.2', 'spread': '9.96', 'groupId': 'BG002'}, {'value': '57.4', 'spread': '6.11', 'groupId': 'BG003'}, {'value': '58.8', 'spread': '9.46', 'groupId': 'BG004'}, {'value': '54.2', 'spread': '10.46', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All treated participants who received at least 1 dose of study therapy.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2009-11-19', 'resultsFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-23', 'studyFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome', 'timeFrame': 'From baseline to 30 days after last dose of study drug', 'description': 'AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.'}, {'measure': 'Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results', 'timeFrame': 'From baseline to 30 days after last dose of study drug', 'description': 'Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= \\<7.0 to 8.9 g/dL, Grade 4= \\<7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm\\^3, Grade 4= \\<350 cells/mm\\^3. Neutrophils: Grade 3= 500-999 cells/mm\\^3, Grade 4= \\<500 cells/mm\\^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm\\^3, Grade 4= \\<1000 cells/mm\\^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10\\*upper limit of normal (ULN), Grade 4= \\>10.0\\*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10\\*ULN, Grade 4= \\>10.0\\*ULN. Total bilirubin: Grade 3= 2.6-5\\*ULN, Grade 4= \\>5.0\\*ULN.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Extended Rapid Virologic Response (eRVR)', 'timeFrame': 'At Weeks 4 and 12 on treatment', 'description': 'eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \\<15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Rapid Virologic Response (RVR)', 'timeFrame': 'At Week 4 on treatment', 'description': 'RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \\<15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .'}, {'measure': 'Percentage of Participants With Complete Early Virologic Response (cEVR)', 'timeFrame': 'At Week 12 on treatment', 'description': 'cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \\<15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory'}, {'measure': 'Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24', 'timeFrame': 'Follow-up Weeks 4, 12, and 24', 'description': 'SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \\<15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .'}, {'measure': 'Percentage of Participants With Virologic Failure', 'timeFrame': 'From on-treatment Week 1 to Follow-up Week 24', 'description': 'Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed \\>1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. \\<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as \\<2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C Infection']}, 'referencesModule': {'references': [{'pmid': '24468783', 'type': 'DERIVED', 'citation': 'Murakami E, Imamura M, Hayes CN, Abe H, Hiraga N, Honda Y, Ono A, Kosaka K, Kawaoka T, Tsuge M, Aikata H, Takahashi S, Miki D, Ochi H, Matsui H, Kanai A, Inaba T, McPhee F, Chayama K. Ultradeep sequencing study of chronic hepatitis C virus genotype 1 infection in patients treated with daclatasvir, peginterferon, and ribavirin. Antimicrob Agents Chemother. 2014;58(4):2105-12. doi: 10.1128/AAC.02068-13. Epub 2014 Jan 27.'}], '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 identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Patients chronically infected with hepatitis C virus (HCV) genotype 1\n* HCV RNA viral load ≥10\\*5\\* IU/mL at screening\n* Naïve or nonresponsive to the current standard of care\n\nKey Exclusion Criteria:\n\n* Cirrhosis\n* Hepatocellular carcinoma\n* Coinfection with hepatitis B virus, HIV-1 or HIV-2'}, 'identificationModule': {'nctId': 'NCT01016912', 'briefTitle': 'Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection', 'orgStudyIdInfo': {'id': 'AI444-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)', 'description': 'Treatment Naive', 'interventionNames': ['Drug: BMS-790052', 'Drug: Peginterferon alfa-2b', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)', 'description': 'Treatment Naive', 'interventionNames': ['Drug: BMS-790052', 'Drug: Peginterferon alfa-2b', 'Drug: Ribavirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)', 'description': 'Treatment Naive', 'interventionNames': ['Drug: Placebo', 'Drug: Peginterferon alfa-2b', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)', 'description': 'Non-Responder', 'interventionNames': ['Drug: BMS-790052', 'Drug: Peginterferon alfa-2b', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)', 'description': 'Non-Responder', 'interventionNames': ['Drug: BMS-790052', 'Drug: Peginterferon alfa-2b', 'Drug: Ribavirin']}], 'interventions': [{'name': 'BMS-790052', 'type': 'DRUG', 'description': 'Tablets, Oral, 10 mg, daily, 24-48 weeks', 'armGroupLabels': ['Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)', 'Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)']}, {'name': 'BMS-790052', 'type': 'DRUG', 'description': 'Tablets, Oral, 60 mg, daily, 24-48 weeks', 'armGroupLabels': ['Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)', 'Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Oral, 0 mg, daily, 48 weeks', 'armGroupLabels': ['Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)']}, {'name': 'Peginterferon alfa-2b', 'type': 'DRUG', 'otherNames': ['PegIntron®'], 'description': 'Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks', 'armGroupLabels': ['Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)', 'Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)', 'Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)', 'Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)', 'Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Rebetol®'], 'description': 'Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks', 'armGroupLabels': ['Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)', 'Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)', 'Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)', 'Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)', 'Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '734-0037', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '060-0033', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '2138587', 'city': 'Kawasaki-Shi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '5650871', 'city': 'Suita-Shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '3500495', 'city': 'Iruma-Gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '105-0001', 'city': 'Minato-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}