Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT01945294
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2013-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Malaysia', 'South Korea', 'Thailand']}, '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': 'C512204', 'term': 'N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide'}, {'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': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 60 weeks', 'description': 'A AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).', 'otherNumAtRisk': 102, 'otherNumAffected': 96, 'seriousNumAtRisk': 102, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).', 'otherNumAtRisk': 105, 'otherNumAffected': 98, 'seriousNumAtRisk': 105, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.', 'otherNumAtRisk': 50, 'otherNumAffected': 46, 'seriousNumAtRisk': 50, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 46, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 34, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 20, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 26, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 48, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 74, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 48, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 21, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Biliary dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hallucinations, mixed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).'}, {'id': 'OG001', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).'}, {'id': 'OG002', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}, {'value': '81.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in SVR12 percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.4', 'ciLowerLimit': '-23.2', 'ciUpperLimit': '0.4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up Week (FW) 12 (up to 40 weeks)', 'description': 'SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA \\< Lower Limit of Quantification \\[LLoQ\\]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants of the Full Analysis Set (FAS) who were treated with any study medication, had undetectable HCV RNA at TW8, and were randomized to Arm 1 or Arm 2. Participants in Arm 3 were not included in the primary efficacy analysis as pre-specified by the protocol.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Undetectable HCV RNA Across Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).'}, {'id': 'OG001', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).'}, {'id': 'OG002', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).'}], 'classes': [{'title': 'TW4', 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'TW8', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'TW12', 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '69.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'TW4, TW8, and TW12', 'description': 'The percentage of participants with undetectable HCV RNA (HCV RNA \\<LLoQ) at TW4, TW8, and TW12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS population (consisting of all participants treated with any study medication who had undetectable HCV RNA at TW8 and were randomized to Arm 1 or Arm 2, and participants with detectable HCV RNA at TW8 in Arm 3) with available data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).'}, {'id': 'OG001', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).'}, {'id': 'OG002', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).'}], 'classes': [{'title': '% Undetectable HCV RNA at TW4 (n=25, 18, 0)', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '% Undetectable HCV RNA at TW8 (n=101, 104, 0)', 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000'}, {'value': '81.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '% Undetectable HCV RNA at TW12 (n=100, 103, 20)', 'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}, {'value': '41.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'TW4, TW8, and TW12', 'description': 'The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA \\<LLoQ) at Week 4, Week 8, and Week 12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset of the FAS population consisting of all participants treated with any study medication in Arms 1, 2, and 3 and who had undetectable HCV RNA at Week 4, Week 8, or Week 12.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).'}, {'id': 'OG001', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).'}, {'id': 'OG002', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From EOT to FW12 (up to 12 weeks)', 'description': 'The percentage of viral relapse (defined as confirmed HCV RNA \\>15 IU/mL after End-of-Treatment \\[EOT\\]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS with undetectable HCV RNA at EOT and who have data available at FW12 were included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Neutropenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).'}, {'id': 'OG001', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).'}, {'id': 'OG002', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '12.4', 'groupId': 'OG001'}, {'value': '4.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 weeks', 'description': 'The percentage of participants with neutropenia (neutrophil count \\<0.75 x10\\^9/L) is summarized for each arm.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).'}, {'id': 'OG001', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).'}, {'id': 'OG002', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}, {'value': '26.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 weeks', 'description': 'The percentage of participants with anemia (hemoglobin \\[Hgb\\] \\<10 g/dL) was determined in each arm.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).'}, {'id': 'OG001', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).'}, {'id': 'OG002', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.'}], 'classes': [{'title': 'Discontinued from BOC', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}, {'value': '16.0', 'groupId': 'OG002'}]}]}, {'title': 'Discontinued from BOC + R', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}, {'value': '8.0', 'groupId': 'OG002'}]}]}, {'title': 'Discontinued from all Study Medication', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}, {'value': '8.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From TW1 through TW48', 'description': 'An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The APaT includes all participants who received ≥1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-Related Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).'}, {'id': 'OG001', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).'}, {'id': 'OG002', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '4.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 60 weeks', 'description': 'A SAE is any AE that results in death, is life threatening, results in persistent or significant disability, results in or prolongs an existing inpatient hospitalization, is a congenital birth defect, is a cancer, is associated with an overdose, or is another important medical event.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The APaT includes all participants who received ≥1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Treated Participants', 'description': 'All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\]) or allocation to Arm 3 (participants with detectable HCV RNA).'}, {'id': 'FG001', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).'}, {'id': 'FG002', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).'}, {'id': 'FG003', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).'}], 'periods': [{'title': 'Period 1: 12-Week PR + BOC Lead-In', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2: BOC+ PR Treatment & Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants were assigned to 1 of the 3 arms after upon the 12-week BOC + PR lead-in.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '105'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '97'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Treatment-naïve adult male and female participants with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection were recruited in the Asia-Pacific region.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: 16-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).'}, {'id': 'BG001', 'title': 'Arm 2: 28-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).'}, {'id': 'BG002', 'title': 'Arm 3: 48-week Treatment Arm', 'description': 'After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '44.6', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '46.5', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '44.8', 'spread': '11.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The total number of participants in Arm 3 (i.e., n=50) includes participants who completed the BOC + PR lead-in and were allocated at Week 12 based on having detectable HCV RNA (n=29), as well as participants who began the BOC + PR lead-in but discontinued prior to Week 12 (n=21).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-14', 'studyFirstSubmitDate': '2013-09-13', 'resultsFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2013-09-13', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-30', 'studyFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]', 'timeFrame': 'Follow-up Week (FW) 12 (up to 40 weeks)', 'description': 'SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA \\< Lower Limit of Quantification \\[LLoQ\\]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Undetectable HCV RNA Across Treatment', 'timeFrame': 'TW4, TW8, and TW12', 'description': 'The percentage of participants with undetectable HCV RNA (HCV RNA \\<LLoQ) at TW4, TW8, and TW12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.'}, {'measure': 'Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment', 'timeFrame': 'TW4, TW8, and TW12', 'description': 'The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA \\<LLoQ) at Week 4, Week 8, and Week 12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.'}, {'measure': 'Percentage of Participants With Relapse', 'timeFrame': 'From EOT to FW12 (up to 12 weeks)', 'description': 'The percentage of viral relapse (defined as confirmed HCV RNA \\>15 IU/mL after End-of-Treatment \\[EOT\\]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.'}, {'measure': 'Percentage of Participants With Neutropenia', 'timeFrame': 'Up to 60 weeks', 'description': 'The percentage of participants with neutropenia (neutrophil count \\<0.75 x10\\^9/L) is summarized for each arm.'}, {'measure': 'Percentage of Participants With Anemia', 'timeFrame': 'Up to 60 weeks', 'description': 'The percentage of participants with anemia (hemoglobin \\[Hgb\\] \\<10 g/dL) was determined in each arm.'}, {'measure': 'Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)', 'timeFrame': 'From TW1 through TW48', 'description': 'An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported.'}, {'measure': 'Percentage of Participants With Treatment-Related Serious AEs (SAEs)', 'timeFrame': 'Up to 60 weeks', 'description': 'A SAE is any AE that results in death, is life threatening, results in persistent or significant disability, results in or prolongs an existing inpatient hospitalization, is a congenital birth defect, is a cancer, is associated with an overdose, or is another important medical event.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* weigh ≥ 40 kg and ≤ 125 kg\n* have CHC genotype 1 infection\n* has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of cirrhosis and hepatocellular carcinoma\n* must agree that the participant and the participant's partner will each use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations (for a female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential)\n\nExclusion Criteria:\n\n* participates in any other interventional clinical trial within 30 days of the screening visit in this trial or intends to participate in another interventional clinical trial during participation in this trial\n* is co-infected with human immunodeficiency virus (HIV) or hepatitis B virus\n* has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis\n* has evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy\n* has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC\n* has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years\n* has been previously treated with an interferon or ribavirin regimen or HCV direct acting anti-viral regimen, or treated for hepatitis C with any investigational medication\n* taking/plans to take significant inducers of inhibitors of Cytochrome P450 3A4 (CYP3A4) substrates 2 weeks prior to start of study medications, or herbal supplements, including but not limited to St. John's Wort 2 weeks prior to start of study medications (Day 1)\n* has pre-existing psychiatric condition(s)\n* has a clinical diagnosis of substance abuse\n* has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction\n* is pregnant or nursing (for female participant) or female partner intends to become pregnant (for male participant)"}, 'identificationModule': {'nctId': 'NCT01945294', 'briefTitle': 'Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3 Clinical Trial to Study Short Duration Versus Standard Response-Guided Therapy With MK-3034 (SCH 503034)/Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Subjects With Chronic HCV Genotype 1 in Asia', 'orgStudyIdInfo': {'id': '3034-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: 16-week Treatment Arm', 'description': 'All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).', 'interventionNames': ['Drug: Boceprevir', 'Biological: Peg-interferon alfa-2b', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: 28-week Treatment Arm', 'description': 'All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).', 'interventionNames': ['Drug: Boceprevir', 'Biological: Peg-interferon alfa-2b', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: 48-week Treatment Arm', 'description': 'All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).', 'interventionNames': ['Drug: Boceprevir', 'Biological: Peg-interferon alfa-2b', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Boceprevir', 'type': 'DRUG', 'otherNames': ['MK-3034'], 'description': '800 mg three times daily orally', 'armGroupLabels': ['Arm 1: 16-week Treatment Arm', 'Arm 2: 28-week Treatment Arm', 'Arm 3: 48-week Treatment Arm']}, {'name': 'Peg-interferon alfa-2b', 'type': 'BIOLOGICAL', 'otherNames': ['PegIntron'], 'description': '1.5 mcg/kg weekly subcutaneously', 'armGroupLabels': ['Arm 1: 16-week Treatment Arm', 'Arm 2: 28-week Treatment Arm', 'Arm 3: 48-week Treatment Arm']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Rebetol'], 'description': '800-1400 mg twice-daily divided orally based on body weight', 'armGroupLabels': ['Arm 1: 16-week Treatment Arm', 'Arm 2: 28-week Treatment Arm', 'Arm 3: 48-week Treatment Arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}