Viewing Study NCT00630058

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Ignite Creation Date: 2025-12-25 @ 12:04 AM
Ignite Modification Date: 2025-12-25 @ 10:02 PM
Study NCT ID: NCT00630058
Status: COMPLETED
Last Update Posted: 2014-05-02
First Post: 2008-02-24
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], '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'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'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': 'D012254', 'term': 'Ribavirin'}, {'id': 'C486464', 'term': 'telaprevir'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group A (MP-424 High)', 'description': 'Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Group B (MP-424 Low)', 'description': 'Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 8}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 5}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 5}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 7}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood luteinising hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eosinophil percentage increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lymphocyte percentage decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lymphocyte percentage increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Basophil percentage decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood bilirubin unconjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lipids abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Monocyte percentage increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eosinophil percentage decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Protein total decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 8}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Frequent bowel movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'High density lipoprotein decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Reticulocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutrophil percentage decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutrophil percentage increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tri-iodothyronine free decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Choking sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Appetite disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax (Maximum Observed Concentration in Plasma) of MP-424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (MP-424 High)', 'description': 'Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}, {'id': 'OG001', 'title': 'Group B (MP-424 Low)', 'description': 'Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}], 'classes': [{'title': 'Day 1 (Group A,B:10 cases)', 'categories': [{'measurements': [{'value': '1.62', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Group A,B:10 cases)', 'categories': [{'measurements': [{'value': '3.96', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (Group A: 6 cases, Group B: 7 cases)', 'categories': [{'measurements': [{'value': '3.67', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data were collected at Day1 to Day85', 'description': 'Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.\n\nData as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tmax (Time of Maximum Concentration in Plasma) of MP-424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (MP-424 High)', 'description': 'Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}, {'id': 'OG001', 'title': 'Group B (MP-424 Low)', 'description': 'Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}], 'classes': [{'title': 'Day 1 (Group A, B:10 cases)', 'categories': [{'measurements': [{'value': '2.51', 'groupId': 'OG000', 'lowerLimit': '2.25', 'upperLimit': '6.00'}, {'value': '2.54', 'groupId': 'OG001', 'lowerLimit': '2.33', 'upperLimit': '8.02'}]}]}, {'title': 'Day 14 (Group A, B:10 cases)', 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '2.42', 'upperLimit': '5.75'}, {'value': '2.45', 'groupId': 'OG001', 'lowerLimit': '2.33', 'upperLimit': '6.00'}]}]}, {'title': 'Day 85 (Group A: 6 cases, Group B: 7 cases)', 'categories': [{'measurements': [{'value': '3.24', 'groupId': 'OG000', 'lowerLimit': '2.35', 'upperLimit': '7.75'}, {'value': '2.43', 'groupId': 'OG001', 'lowerLimit': '2.33', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Data were collected at Day1 to Day85', 'description': 'Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.\n\nData as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (MP-424 High)', 'description': 'Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}, {'id': 'OG001', 'title': 'Group B (MP-424 Low)', 'description': 'Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}], 'classes': [{'title': 'Day 1 (Group A, B: 10 cases)', 'categories': [{'measurements': [{'value': '7.53', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '6.55', 'spread': '3.73', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Group A: 9 cases, Group B: 10 cases)', 'categories': [{'measurements': [{'value': '26.00', 'spread': '6.77', 'groupId': 'OG000'}, {'value': '19.94', 'spread': '5.97', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 (Group A: 6 cases, Group B: 7 cases)', 'categories': [{'measurements': [{'value': '25.00', 'spread': '5.23', 'groupId': 'OG000'}, {'value': '21.35', 'spread': '6.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data were collected at Day1 to Day85', 'description': 'Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.\n\nData as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ctrough (Minimum Observed Concentration in Plasma) of MP-424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (MP-424 High)', 'description': 'Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}, {'id': 'OG001', 'title': 'Group B (MP-424 Low)', 'description': 'Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}], 'classes': [{'title': 'Day1 (Group A,B: 10 cases)', 'categories': [{'measurements': [{'value': '0.846', 'spread': '0.500', 'groupId': 'OG000'}, {'value': '0.681', 'spread': '0.412', 'groupId': 'OG001'}]}]}, {'title': 'Day14 (Group A: 9 cases, Group B:10cases)', 'categories': [{'measurements': [{'value': '2.639', 'spread': '0.556', 'groupId': 'OG000'}, {'value': '1.914', 'spread': '0.717', 'groupId': 'OG001'}]}]}, {'title': 'Day85 (Group A: 6 cases, Group B:7cases)', 'categories': [{'measurements': [{'value': '2.679', 'spread': '0.355', 'groupId': 'OG000'}, {'value': '2.105', 'spread': '0.819', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data were collected at Day1 to Day85', 'description': 'Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.\n\nData as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'T1/2(Time of Half-Life) of MP-424', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (MP-424 High)', 'description': 'Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}, {'id': 'OG001', 'title': 'Group B (MP-424 Low)', 'description': 'Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}], 'classes': [{'title': 'Day1 (Group A: 7 cases, Group B: 8 cases)', 'categories': [{'measurements': [{'value': '4.87', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '4.03', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Day14 (Group A: 8 cases, Group B: 9 cases)', 'categories': [{'measurements': [{'value': '9.99', 'spread': '4.37', 'groupId': 'OG000'}, {'value': '10.00', 'spread': '6.97', 'groupId': 'OG001'}]}]}, {'title': 'Day85 (Group A: 6 cases, Group B: 7 cases)', 'categories': [{'measurements': [{'value': '9.06', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '6.22', 'spread': '3.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data were collected at Day1 to Day85', 'description': 'Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.\n\nData as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (MP-424 High)', 'description': 'Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}, {'id': 'OG001', 'title': 'Group B (MP-424 Low)', 'description': 'Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}], 'classes': [{'title': 'Day 1_2.5h (Group A,B: 10 cases)', 'categories': [{'measurements': [{'value': '-0.190', 'spread': '0.235', 'groupId': 'OG000'}, {'value': '-0.220', 'spread': '0.329', 'groupId': 'OG001'}]}]}, {'title': 'Day 1_4h (Group A,B: 10 cases)', 'categories': [{'measurements': [{'value': '-0.420', 'spread': '0.264', 'groupId': 'OG000'}, {'value': '-0.390', 'spread': '0.378', 'groupId': 'OG001'}]}]}, {'title': 'Day 1_8h (Group A,B: 10 cases)', 'categories': [{'measurements': [{'value': '-1.300', 'spread': '0.294', 'groupId': 'OG000'}, {'value': '-1.310', 'spread': '0.309', 'groupId': 'OG001'}]}]}, {'title': 'Day 1_16h (Group A,B: 10 cases)', 'categories': [{'measurements': [{'value': '-2.350', 'spread': '0.458', 'groupId': 'OG000'}, {'value': '-2.480', 'spread': '0.286', 'groupId': 'OG001'}]}]}, {'title': 'Day 2 (Group A,B: 10 cases)', 'categories': [{'measurements': [{'value': '-3.010', 'spread': '0.340', 'groupId': 'OG000'}, {'value': '-3.180', 'spread': '0.220', 'groupId': 'OG001'}]}]}, {'title': 'Day 3 (Group A,B: 10 cases)', 'categories': [{'measurements': [{'value': '-3.610', 'spread': '0.453', 'groupId': 'OG000'}, {'value': '-3.790', 'spread': '0.407', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 (Group A,B: 10 cases)', 'categories': [{'measurements': [{'value': '-4.840', 'spread': '0.622', 'groupId': 'OG000'}, {'value': '-5.010', 'spread': '0.551', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (Group A,B: 10 cases)', 'categories': [{'measurements': [{'value': '-5.570', 'spread': '0.579', 'groupId': 'OG000'}, {'value': '-5.800', 'spread': '0.554', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (Group A: 10 cases, Group B: 9 cases)', 'categories': [{'measurements': [{'value': '-5.860', 'spread': '0.611', 'groupId': 'OG000'}, {'value': '-5.978', 'spread': '0.519', 'groupId': 'OG001'}]}]}, {'title': 'Day 43 (Group A: 8 cases, Group B: 8 cases)', 'categories': [{'measurements': [{'value': '-6.000', 'spread': '0.573', 'groupId': 'OG000'}, {'value': '-5.994', 'spread': '0.590', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (Group A: 7 cases, Group B: 8 cases)', 'categories': [{'measurements': [{'value': '-5.986', 'spread': '0.538', 'groupId': 'OG000'}, {'value': '-5.994', 'spread': '0.539', 'groupId': 'OG001'}]}]}, {'title': 'Day 86 (Group A: 6 cases, Group B: 7 cases)', 'categories': [{'measurements': [{'value': '-6.000', 'spread': '0.588', 'groupId': 'OG000'}, {'value': '-6.114', 'spread': '0.609', 'groupId': 'OG001'}]}]}, {'title': 'Day 92 (Group A: 6 cases, Group B: 7 cases)', 'categories': [{'measurements': [{'value': '-6.000', 'spread': '0.588', 'groupId': 'OG000'}, {'value': '-6.114', 'spread': '0.609', 'groupId': 'OG001'}]}]}, {'title': 'Day 99 (Group A: 6 cases, Group B: 7 cases)', 'categories': [{'measurements': [{'value': '-6.000', 'spread': '0.588', 'groupId': 'OG000'}, {'value': '-5.471', 'spread': '1.065', 'groupId': 'OG001'}]}]}, {'title': 'Day 113 (Group A: 6 cases, Group B: 7 cases)', 'categories': [{'measurements': [{'value': '-5.917', 'spread': '0.564', 'groupId': 'OG000'}, {'value': '-3.457', 'spread': '2.591', 'groupId': 'OG001'}]}]}, {'title': 'Day 141 (Group A: 6 cases, Group B: 7 cases)', 'categories': [{'measurements': [{'value': '-4.233', 'spread': '2.455', 'groupId': 'OG000'}, {'value': '-3.000', 'spread': '2.865', 'groupId': 'OG001'}]}]}, {'title': 'Day 169 (Group A: 6 cases, Group B: 6 cases)', 'categories': [{'measurements': [{'value': '-3.100', 'spread': '2.827', 'groupId': 'OG000'}, {'value': '-3.267', 'spread': '3.067', 'groupId': 'OG001'}]}]}, {'title': 'Day 197 (Group A: 6 cases, Group B: 6 cases)', 'categories': [{'measurements': [{'value': '-2.850', 'spread': '2.947', 'groupId': 'OG000'}, {'value': '-3.283', 'spread': '3.031', 'groupId': 'OG001'}]}]}, {'title': 'Day 225 (Group A: 6 cases, Group B: 6 cases)', 'categories': [{'measurements': [{'value': '-2.633', 'spread': '2.748', 'groupId': 'OG000'}, {'value': '-3.183', 'spread': '3.140', 'groupId': 'OG001'}]}]}, {'title': 'Day 253 (Group A: 6 cases, Group B: 6 cases)', 'categories': [{'measurements': [{'value': '-1.883', 'spread': '3.177', 'groupId': 'OG000'}, {'value': '-3.100', 'spread': '3.234', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '37 weeks', 'description': 'HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2-7.8 log10 IU/mL.', 'unitOfMeasure': 'Log IU / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A (MP-424 High)', 'description': 'Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}, {'id': 'FG001', 'title': 'Group B (MP-424 Low)', 'description': 'Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'stopping criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A (MP-424 High)', 'description': 'Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}, {'id': 'BG001', 'title': 'Group B (MP-424 Low)', 'description': 'Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir\n\nDrug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks\n\nDrug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '54.3', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '52.2', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-16', 'studyFirstSubmitDate': '2008-02-24', 'resultsFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2008-02-26', 'lastUpdatePostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-12', 'studyFirstPostDateStruct': {'date': '2008-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (Maximum Observed Concentration in Plasma) of MP-424', 'timeFrame': 'Data were collected at Day1 to Day85', 'description': 'Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.\n\nData as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.'}, {'measure': 'Tmax (Time of Maximum Concentration in Plasma) of MP-424', 'timeFrame': 'Data were collected at Day1 to Day85', 'description': 'Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.\n\nData as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.'}, {'measure': 'AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424', 'timeFrame': 'Data were collected at Day1 to Day85', 'description': 'Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.\n\nData as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.'}, {'measure': 'Ctrough (Minimum Observed Concentration in Plasma) of MP-424', 'timeFrame': 'Data were collected at Day1 to Day85', 'description': 'Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.\n\nData as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.'}, {'measure': 'T1/2(Time of Half-Life) of MP-424', 'timeFrame': 'Data were collected at Day1 to Day85', 'description': 'Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.\n\nData as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.'}], 'secondaryOutcomes': [{'measure': 'Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels', 'timeFrame': '37 weeks', 'description': 'HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2-7.8 log10 IU/mL.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Hepatitis C', 'Protease Inhibitor', 'Telaprevir'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '23190247', 'type': 'RESULT', 'citation': 'Suzuki F, Suzuki Y, Sezaki H, Akuta N, Seko Y, Kawamura Y, Hosaka T, Kobayashi M, Saito S, Arase Y, Ikeda K, Mineta R, Watahiki S, Kobayashi M, Nakayasu Y, Tsuda H, Aoki K, Yamada I, Kumada H. Exploratory study on telaprevir given every 8 h at 500 mg or 750 mg with peginterferon-alpha-2b and ribavirin in hepatitis C patients. Hepatol Res. 2013 Jul;43(7):691-701. doi: 10.1111/hepr.12009. Epub 2012 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with genotype 1b chronic hepatitis C\n\nExclusion Criteria:\n\n* Patients diagnosed with decompensated cirrhosis\n* Patients diagnosed with positive HBs antigen in the test'}, 'identificationModule': {'nctId': 'NCT00630058', 'briefTitle': 'A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Phase I, Open-Label, Two-Arm Study of MP-424 in Combination With Peginterferon Alfa 2b and Ribavirin in Patients With Genotype 1b Hepatitis C', 'orgStudyIdInfo': {'id': 'G060-A5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (MP-424 High)', 'interventionNames': ['Drug: MP-424(H), PEG-IFN-a-2b, RBV']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (MP-424 Low)', 'interventionNames': ['Drug: MP-424 (L), PEG-IFN-a-2b, RBV']}], 'interventions': [{'name': 'MP-424(H), PEG-IFN-a-2b, RBV', 'type': 'DRUG', 'otherNames': ['Telaprevir'], 'description': 'MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks', 'armGroupLabels': ['Group A (MP-424 High)']}, {'name': 'MP-424 (L), PEG-IFN-a-2b, RBV', 'type': 'DRUG', 'otherNames': ['Telaprevir'], 'description': 'MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks', 'armGroupLabels': ['Group B (MP-424 Low)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kawasaki', 'state': 'Takatsu-ku', 'country': 'Japan', 'facility': 'Toranomon Hospital', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}], 'overallOfficials': [{'name': 'Fumitaka Suzuki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Hepatology, Toranomon Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}