Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-08 @ 6:50 PM
Study NCT ID:
NCT00556504
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2007-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'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': 'yachunwang@tcmbio.com', 'phone': '886-2-26581677', 'title': 'Dr. Ya-Chun Wang, EVP/CSO', 'phoneExt': '733', 'organization': 'TCM Biotech International'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '72 weeks', 'description': 'Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study.\n\none patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'TCM-700C (Safety Population)', 'description': 'TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C', 'otherNumAtRisk': 41, 'otherNumAffected': 41, 'seriousNumAtRisk': 41, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Placebo (Safety Population)', 'description': 'Placebo with convetional treatment(PegIFN plus RBV) for HCV patients', 'otherNumAtRisk': 42, 'otherNumAffected': 40, 'seriousNumAtRisk': 42, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Palpiations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Conjunctivities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Abdominal distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Apthous stomatits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Reflux esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hyperuricaemi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypoesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Urinary incontinency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Urinary infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}, {'term': 'Fever/pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}, {'term': 'block stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}, {'term': 'hearing impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Rhinorhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'neuritic depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'lose weight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sustained Virologic Response (SVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TCM-700C', 'description': 'TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nTCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nPlacebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after the termination of combinational drug treatment (up to 72 weeks)', 'description': "SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment..\n\n1. A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72.\n2. If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value.\n3. If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable.\n\nSerum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)", 'unitOfMeasure': 'Number of participants with SVR', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Virologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TCM-700C', 'description': 'TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nTCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nPlacebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of combination drug treatment (up to 48 weeks)', 'description': 'undetectable HCV RNA at the end of combination drug treatment\n\nSerum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ALT Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TCM-700C', 'description': 'TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nTCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nPlacebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of combination drug treatment (up to 48 weeks)', 'description': 'An ALT response is defined as normalization of ALT at the end of combination drug treatment.\n\n(ALT normalization is defined as ALT level decreases into within the normal range)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained ALT Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TCM-700C', 'description': 'TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nTCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nPlacebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after the termination of combinational drug treatment (up to 72 weeks)', 'description': 'a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Combined ALT and Virologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TCM-700C', 'description': 'TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nTCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nPlacebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of combination drug treatment (up to 48 weeks)', 'description': 'Combined ALT and virologic response at the end of combination drug treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immune Cell Normalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TCM-700C', 'description': 'TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nTCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nPlacebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}], 'classes': [{'title': 'CD4', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'CD8', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'NK cells', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of combination drug treatment (up to 48 weeks)', 'description': 'Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment\n\n(Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immune Cell Normalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TCM-700C', 'description': 'TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nTCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nPlacebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}], 'classes': [{'title': 'CD4', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'CD8', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'NK cells', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after the termination of combinational drug treatment (up to 72 weeks)', 'description': 'Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TCM-700C', 'description': 'TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nTCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C\n\nPlacebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Intend-to Treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'recruitment period: 12 Months location: CGMH clinical ceters'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TCM-700C', 'description': 'TCM-700C, an add-on drug to conventional treatment of Hepatitis C'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo with convetional treatment for HCV patients'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '9.58', 'groupId': 'BG000'}, {'value': '48.74', 'spread': '11.52', 'groupId': 'BG001'}, {'value': '48.67', 'spread': '10.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fibrosis score', 'classes': [{'title': 'Fibrosis score 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Fibrosis score 1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Fibrosis score 2', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR system fibrosis score\n\n0 No fibrosis\n\n1. Stellate enlargement of portal tract but without septa formation\n2. Enlargement of portal tract with rare septa formation', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2007-11-08', 'resultsFirstSubmitDate': '2013-06-05', 'studyFirstSubmitQcDate': '2007-11-09', 'lastUpdatePostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-05', 'studyFirstPostDateStruct': {'date': '2007-11-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Virologic Response (SVR)', 'timeFrame': '24 weeks after the termination of combinational drug treatment (up to 72 weeks)', 'description': "SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment..\n\n1. A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72.\n2. If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value.\n3. If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable.\n\nSerum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)"}], 'secondaryOutcomes': [{'measure': 'Virologic Response', 'timeFrame': 'at the end of combination drug treatment (up to 48 weeks)', 'description': 'undetectable HCV RNA at the end of combination drug treatment\n\nSerum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit).'}, {'measure': 'ALT Response', 'timeFrame': 'at the end of combination drug treatment (up to 48 weeks)', 'description': 'An ALT response is defined as normalization of ALT at the end of combination drug treatment.\n\n(ALT normalization is defined as ALT level decreases into within the normal range)'}, {'measure': 'Sustained ALT Response', 'timeFrame': '24 weeks after the termination of combinational drug treatment (up to 72 weeks)', 'description': 'a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment.'}, {'measure': 'Combined ALT and Virologic Response', 'timeFrame': 'at the end of combination drug treatment (up to 48 weeks)', 'description': 'Combined ALT and virologic response at the end of combination drug treatment.'}, {'measure': 'Immune Cell Normalization', 'timeFrame': 'at the end of combination drug treatment (up to 48 weeks)', 'description': 'Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment\n\n(Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range)'}, {'measure': 'Immune Cell Normalization', 'timeFrame': '24 weeks after the termination of combinational drug treatment (up to 72 weeks)', 'description': 'Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['add-on treatment', 'botanical drug', 'HCV genotype 1', 'TCM-700C', 'genotype I'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the effectiveness of TCM-700C as an add-on treatment to the combination drug therapy (Peginterferon α-2b plus Ribavirin) for patients with genotype 1 chronic hepatitis C infections. This will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment, compared with the placebo add-on.', 'detailedDescription': 'This was a randomized, double-blind, placebo controlled, parallel-group, Phase 2 study to evaluate the effects of adding a Chinese formulation (TCM-700C) on the standard combination treatment for patients with Genotype 1 hepatitis C infection. Patients were screened within 4 weeks before receive the first study drug dose. Eligible patients at baseline were stratified according to baseline HCV RNA (≤800,000 IU/ml vs \\>800,000 IU/ml) and randomized with an equal chance to receive either TCM-700C or placebo as an add-on to the combination drug therapy. The combination drug therapy was peginterferon α-2b (PEG-INTRON®, Schering-Plough) 1.5 micrograms/kg once weekly injection for 48 weeks plus oral ribavirin (REBETOL®, Shering-Plough) 1000mg-1200mg daily for 48 weeks. The add-on treatment of TCM-700C or placebo was given 2 tablets thrice daily for 48 weeks.\n\nDuring the 48 week treatment period and 24 week untreated follow-up, patients were assessed at regular intervals for safety and efficacy at weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. Patients who prematurely discontinued test drug therapy had laboratory examination re-taken on the week patient was discontinued from study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HCV strain confirmed as genotype I;\n* Elevated ALT (≥1.5 x upper limit of normal)during last 6 months\n* Females of childbearing potential with a negative serum pregnancy test\n* Subject must be willing to sign a written informed consent\n* Subject must be willing and able to adhere to dose and visit schedule.\n\nExclusion Criteria:\n\n* Serum AFP levels \\> 400 ng/ml\n* Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR system fibrosis score of 3-4, or hepatocellular carcinoma (HCC);\n* Co-infection with hepatitis B virus (HBV);\n* Anti-HIV positive;'}, 'identificationModule': {'nctId': 'NCT00556504', 'acronym': 'TCM-700C', 'briefTitle': 'The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCM Biotech International Corp.'}, 'officialTitle': 'TCM-700C Phase II Trial The Effects of Adding a Chinese Formulation (TCM-700C) on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection', 'orgStudyIdInfo': {'id': 'TCM-700-01-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TCM-700C', 'description': 'an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C', 'interventionNames': ['Drug: TCM-700C', 'Drug: Peginterferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C', 'interventionNames': ['Drug: Peginterferon alfa-2a', 'Drug: Ribavirin', 'Drug: Placebo']}], 'interventions': [{'name': 'TCM-700C', 'type': 'DRUG', 'description': 'An add-on drug to conventional treatment of Hepatitis C', 'armGroupLabels': ['TCM-700C']}, {'name': 'Peginterferon alfa-2a', 'type': 'DRUG', 'otherNames': ['Peg-INTRON, Schering-Plough'], 'description': 'conventional treatment of Hepatitis C', 'armGroupLabels': ['Placebo', 'TCM-700C']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Rebetol, Schering-Plough)'], 'description': 'conventional treatment of Hepatitis C', 'armGroupLabels': ['Placebo', 'TCM-700C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, without acting ingredient.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'I-Sheen Sheen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCM Biotech International Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}