Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-28 @ 11:47 AM
Study NCT ID:
NCT00513461
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2007-08-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007124', 'term': 'Immunoenzyme Techniques'}, {'id': 'D002851', 'term': 'Chromatography, High Pressure Liquid'}], 'ancestors': [{'id': 'D007118', 'term': 'Immunoassay'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}, {'id': 'D002853', 'term': 'Chromatography, Liquid'}, {'id': 'D002845', 'term': 'Chromatography'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'timothy.morgan@va.gov', 'phone': '562-826-5756', 'title': 'Dr. Timothy R. Morgan', 'organization': 'University of California, Irvine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 30 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies', 'otherNumAtRisk': 57, 'otherNumAffected': 51, 'seriousNumAtRisk': 57, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies', 'otherNumAtRisk': 53, 'otherNumAffected': 46, 'seriousNumAtRisk': 53, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'ABDOMINAL CRAMPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ALLERGIC RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ANAL IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTHRITIS PAIN, KNEES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTHRITIS PAIN, LOWER BACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ASCITES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BAD GAS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BLACK OUT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BLEEDING ESPHAGEAL VARICES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BLOOD IN STOOLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BLURRED VISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BORDERLINE DIABETES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BREAST TENDERNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BROKEN TOOTH-UNCOMPLICATED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'BRUISING R LEG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CHEST CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CHRONIC ASCITES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CHRONIC GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CLICKING SOUND IN THE HEAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COLD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COMMON COLD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'CYST ON PATELLA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DARK COLORED URINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DECREASED INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DENTAL IMPLANT SURGERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 31, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DIARRHEA 4-6 STOOLS/DAY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DIFFUSE ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DISLOCATION OF LEFT SHOULDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRY MOUTH/SALIVARY GLAND', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'DRYNESS OF MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'EAR PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'EARS RINGING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ELEVATED AFP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ELEVATED CREATININE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ELEVATED INR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'EXTRA GAS FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'EYE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'EYES HURT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FACIAL SWELLING OF ALLERGIC ORIGIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FALL, HIP AND BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FEET AND LEGS CRAMPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FEVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FLU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FLU-LIKE SYMPTOMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FOOD POISONING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FORGETFULNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'FRACTURE 5TH R METACARPAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GAS-FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GUM BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HAIR LOSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HAPPIER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 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'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'STIFF NECK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'STIFFNESS OF JOINTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'STOMACH ACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'STOMACH CRAMPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'STOMACH FLU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'STOMACH PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SWEATING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SWEATING "NIGHT"', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SWELLING OF ANKLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'TICS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'TINNITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'TIREDNESS FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'TOOTH EXTRACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ULCERATION OF THE LIP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'UPSET STOMACH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'URINE ODOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VAGINAL IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VAGINAL YEAST INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VIRAL INFECTION INCLUDING COUGHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VITAMIN D DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VIVID DREAMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'WEIGHT GAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'WORSENING OF ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'WORSENING OF BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'WORSENING OF BASELINE DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'ABDOMINAL CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL PAIN.STATUS POST SPLENIC ARTERY EMBOLIZATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ANGIOPLASTY OF LEFT HYPOGASTRIC ARTERY, EXTERNAL ILIAC STENT PLACEMENT FOR LEFT LEG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HEPATOCELLULAR CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'LEFT THIGH ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'NEPHROTIC SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'NON-ST ELEVATION MIOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SMALL BOWEL INFLAMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SPLENOMEGALY SECONDARY TO PORTAL HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum AFP Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.928', 'spread': '20.304', 'groupId': 'OG000'}, {'value': '5.855', 'spread': '29.207', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.160', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.78', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data anlysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.259', 'spread': '0.976', 'groupId': 'OG000'}, {'value': '0.647', 'spread': '1.491', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.144', 'spread': '1.146', 'groupId': 'OG000'}, {'value': '0.335', 'spread': '3.486', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'AFP-L3 assay will be performed by Wako Laboratories using their LiBASys platform.', 'unitOfMeasure': 'percentage of AFP-L3/AFP', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'SAMe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '414.242', 'spread': '744.373', 'groupId': 'OG000'}, {'value': '-9.085', 'spread': '54.621', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Change in SAMe levels', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Change in SAMe Metabolites - S-adenosylhomocysteine (SAH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '16.326', 'spread': '28.212', 'groupId': 'OG000'}, {'value': '-3.456', 'spread': '13.104', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'S-adenosylhomocysteine (SAH)', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Change in SAMe Metabolites - Methionine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.421', 'spread': '18.794', 'groupId': 'OG000'}, {'value': '-2.894', 'spread': '23.669', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Methionine will be measured using HPLC with fluorescence detection.', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Change in SAMe Metabolites - Total Homocysteine (tHcy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.266', 'spread': '2.394', 'groupId': 'OG000'}, {'value': '-0.677', 'spread': '2.478', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Total homocysteine (tHcy)', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Change in SAMe Metabolites - Plasma GSH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.455', 'spread': '1.425', 'groupId': 'OG000'}, {'value': '0.285', 'spread': '1.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Plasma GSH will be measured using HPLC with fluorescence detection.', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Change in SAMe Metabolites - Malondialdehyde (MDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.007', 'spread': '0.848', 'groupId': 'OG000'}, {'value': '-0.002', 'spread': '1.162', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'malondialdehyde', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.185', 'spread': '0.716', 'groupId': 'OG000'}, {'value': '-0.032', 'spread': '0.448', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Serum marker of oxidative stress. One mechanism by which SAMe is hypothesized to be beneficial is by reducing oxidative stress.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Change in Markers of Liver Disease - AST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.755', 'spread': '37.531', 'groupId': 'OG000'}, {'value': '1.723', 'spread': '40.709', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'AST measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Change in Markers of Liver Disease - ALT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.548', 'spread': '34.786', 'groupId': 'OG000'}, {'value': '0.019', 'spread': '41.165', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'ALT measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'HCV RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '-259327.69', 'spread': '3084015.42', 'groupId': 'OG000'}, {'value': '-19968.89', 'spread': '2425010.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Change in HCV RNA levels. Serum level of HVC RNA was measured using COBAS TaqMan HCV test (Roche Molecular Systems).', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life - Physical Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '11.73', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '13.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.878', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.43', 'statisticalMethod': 'Two-Group t-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Physical Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change in QOL = (Week 24 score - Baseline score).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life - Mental Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'OG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '15.06', 'groupId': 'OG000'}, {'value': '-2.83', 'spread': '11.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.212', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.66', 'statisticalMethod': 'Two-Group t-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 24', 'description': 'Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Mental Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change = (Week 24 score - Baseline score).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'FG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nS-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'BG001', 'title': 'Arm II (Placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nplacebo: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nimmunoenzyme technique: Correlative studies\n\nhigh performance liquid chromatography: Correlative studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '57.88', 'spread': '5.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2007-08-06', 'resultsFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2007-08-06', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-09', 'studyFirstPostDateStruct': {'date': '2007-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum AFP Levels', 'timeFrame': 'Baseline to week 24', 'description': 'Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model.'}], 'secondaryOutcomes': [{'measure': 'Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma', 'timeFrame': 'Baseline to week 24', 'description': 'To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).'}, {'measure': 'Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma', 'timeFrame': 'Baseline to week 24', 'description': 'AFP-L3 assay will be performed by Wako Laboratories using their LiBASys platform.'}, {'measure': 'SAMe', 'timeFrame': 'Baseline to week 24', 'description': 'Change in SAMe levels'}, {'measure': 'Change in SAMe Metabolites - S-adenosylhomocysteine (SAH)', 'timeFrame': 'Baseline to week 24', 'description': 'S-adenosylhomocysteine (SAH)'}, {'measure': 'Change in SAMe Metabolites - Methionine', 'timeFrame': 'Baseline to week 24', 'description': 'Methionine will be measured using HPLC with fluorescence detection.'}, {'measure': 'Change in SAMe Metabolites - Total Homocysteine (tHcy)', 'timeFrame': 'Baseline to week 24', 'description': 'Total homocysteine (tHcy)'}, {'measure': 'Change in SAMe Metabolites - Plasma GSH', 'timeFrame': 'Baseline to week 24', 'description': 'Plasma GSH will be measured using HPLC with fluorescence detection.'}, {'measure': 'Change in SAMe Metabolites - Malondialdehyde (MDA)', 'timeFrame': 'Baseline to week 24', 'description': 'malondialdehyde'}, {'measure': 'Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE)', 'timeFrame': 'Baseline to week 24', 'description': 'Serum marker of oxidative stress. One mechanism by which SAMe is hypothesized to be beneficial is by reducing oxidative stress.'}, {'measure': 'Change in Markers of Liver Disease - AST', 'timeFrame': 'Baseline to week 24', 'description': 'AST measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.'}, {'measure': 'Change in Markers of Liver Disease - ALT', 'timeFrame': 'Baseline to week 24', 'description': 'ALT measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.'}, {'measure': 'HCV RNA', 'timeFrame': 'Baseline to week 24', 'description': 'Change in HCV RNA levels. Serum level of HVC RNA was measured using COBAS TaqMan HCV test (Roche Molecular Systems).'}, {'measure': 'Changes in Quality of Life - Physical Score', 'timeFrame': 'Baseline to week 24', 'description': 'Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Physical Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change in QOL = (Week 24 score - Baseline score).'}, {'measure': 'Changes in Quality of Life - Mental Score', 'timeFrame': 'Baseline to week 24', 'description': 'Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Mental Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change = (Week 24 score - Baseline score).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adult Primary Liver Cancer', 'Hepatitis C Infection']}, 'referencesModule': {'references': [{'pmid': '26130251', 'type': 'RESULT', 'citation': 'Morgan TR, Osann K, Bottiglieri T, Pimstone N, Hoefs JC, Hu KQ, Hassanein T, Boyer TD, Kong L, Chen WP, Richmond E, Gonzalez R, Rodriguez LM, Meyskens FL. A Phase II Randomized, Controlled Trial of S-Adenosylmethionine in Reducing Serum alpha-Fetoprotein in Patients with Hepatitis C Cirrhosis and Elevated AFP. Cancer Prev Res (Phila). 2015 Sep;8(9):864-72. doi: 10.1158/1940-6207.CAPR-15-0029. Epub 2015 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial studies how well S-Adenosyl-L-Methionine Disulphate P-Toluene-Sulfonate (SAMe) works compared to a placebo in preventing liver cancer in patients with chronic hepatitis C infection. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of SAMe may keep cancer from forming in patients with advanced liver disease', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine whether treatment with SAMe for 24 weeks reduces serum level of alpha-fetoprotein (AFP) in patients with advanced liver disease due to chronic hepatitis C.\n\nSECONDARY OBJECTIVE:\n\nI. To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) and alpha-fetoprotein-L3 (AFP-L3) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).\n\nII. To determine whether treatment with SAMe for 24 weeks alters biochemical markers of liver disease (e.g., serum alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], albumin, or bilirubin, etc.) and hepatitis C viral load in patients with advanced liver disease due to chronic hepatitis C (hepatitis C liver disease).\n\nIII. To determine whether treatment with SAMe for 24 weeks reduces serum levels of tumor necrosis factor-alpha (TNF-alpha), plasma levels of malondialdehyde (MDA), 4-hydroxynonenal (4-HNE) and urine levels of F2-isoprostane in patients with advanced liver disease due to chronic hepatitis C (oxidative stress).\n\nIV. To determine whether treatment with SAMe for 24 weeks reduces plasma levels of methionine and homocysteine and increases plasma glutathione (GSH) and SAMe in patients with advanced liver disease due to chronic hepatitis C (SAMe metabolites).\n\nV. To determine the safety, tolerability and quality of life of SAMe treatment (up to 2,400 mg/day) for 24 weeks in patients with advanced liver disease due to chronic hepatitis C.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive SAMe orally (PO) twice daily (BID) for 24 weeks in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients receive placebo PO once daily (QD) for weeks 1-4, PO BID for weeks 5-8, and PO three times daily (TID) for weeks 9-24 in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic hepatitis C infection diagnosed by presence of hepatitis C ribonucleic acid (RNA) in serum by test of hepatitis C virus (HCV) RNA\n* No significant alcohol use (7 or fewer drinks per week) for the past 12 months\n* Serum AFP (at screening) between 15 and 100 ng/mL (15 ng/mL =\\< AFP =\\< 100 ng/mL) as measured by the Bayer Advai Centaur chemiluminescence system OR Serum AFP between 10 and 100 ng/mL (10 ng/mL =\\< AFP =\\<100 ng/mL) as measured by Diagnostic Products Corporation Immulite assay system OR AFP between 12 and 100 ng/mL (12 ng/mL =\\< AFP =\\< 100 ng/mL) as measured by Ortho ECiQ assay system\n* Evidence of advanced liver disease based on one or more of the following:\n* Platelet count less than 150,000/mm\\^3\n* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio \\> 0.75\n* Liver biopsy demonstrating bridging fibrosis or cirrhosis\n* No treatment with interferon (recombinant interferon alfa), peginterferon (PEG-interferon alfa-2b), or ribavirin for at least 4 months, and not anticipated to start specific treatment for hepatitis C during the study (30 weeks)\n* Ultrasound (or adequate computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\]) examination of the liver within 6 months prior to randomization revealing no masses in the liver suggestive of hepatocellular carcinoma\n* Willing to refrain from consuming over-the-counter SAMe and vitamin pills containing B-vitamins while participating in this study (30 weeks)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Leukocytes \\> 1,000/ mm\\^3\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Liver disease other than from hepatitis C (e.g., hepatitis B, hemochromatosis, fat in more than 33% of hepatocytes, if liver biopsy has been performed., etc.); subjects with a past history of alcohol use can be enrolled into the study provided they have consumed less than 7 drinks/week for the past 12 months\n* Evidence of mass in liver by radiologic examination that is suggestive of hepatocellular carcinoma within 6 months prior to randomization\n* Model for End-Stage Liver Disease (MELD) score greater than 15 within 60 days prior to enrollment\n* Ascites which is clinically detectable\n* Use of SAMe during 4 months prior to randomization\n* Hospitalization within the past 5 years for mania or for bipolar disease\n* Concurrent use of monoamine oxidase inhibitors (MAO) or other drugs that increase the concentration of serotonin\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAMe\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Children are excluded from this study but will be eligible for future pediatric trials, if applicable\n* Pregnant women are excluded from this study; serum pregnancy must be performed and be negative in all women of child bearing potential within 2 weeks prior to enrollment; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SAMe, breastfeeding should be discontinued if the mother is treated with SAMe\n* Subjects with any medical psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation in and compliance with the study criteria"}, 'identificationModule': {'nctId': 'NCT00513461', 'briefTitle': 'Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'A Phase II, Randomized, Controlled Trial of The Safety and Efficacy of S-Adenosyl-L-Methionine Disulphate P-Toluene-Sulfonate (SAMe) in Reducing Serum Alpha-Fetoprotein (AFP) in Patients With Hepatitis C and Moderately Elevated AFP', 'orgStudyIdInfo': {'id': 'UCI 06-07 / NCI-2009-00897'}, 'secondaryIdInfos': [{'id': 'N01CN35160', 'link': 'https://reporter.nih.gov/quickSearch/N01CN35160', 'type': 'NIH'}, {'id': 'CDR0000558657', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'UCI04-3-01', 'type': 'OTHER_GRANT', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (SAMe)', 'description': 'Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate', 'Other: laboratory biomarker analysis', 'Other: immunoenzyme technique', 'Other: high performance liquid chromatography']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II (placebo)', 'description': 'Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Other: placebo', 'Other: laboratory biomarker analysis', 'Other: immunoenzyme technique', 'Other: high performance liquid chromatography']}], 'interventions': [{'name': 'S-adenosyl-L-methionine disulfate p-toluene-sulfonate', 'type': 'DRUG', 'otherNames': ['SAMe disulfate p-toluene-sulfonate'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (SAMe)']}, {'name': 'placebo', 'type': 'OTHER', 'otherNames': ['PLCB'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (placebo)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (SAMe)', 'Arm II (placebo)']}, {'name': 'immunoenzyme technique', 'type': 'OTHER', 'otherNames': ['immunoenzyme techniques'], 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (SAMe)', 'Arm II (placebo)']}, {'name': 'high performance liquid chromatography', 'type': 'OTHER', 'otherNames': ['HPLC'], 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (SAMe)', 'Arm II (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Administration Long Beach Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Administration Los Angeles Healthcare System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California At San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'John Hoefs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chao Family Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chao Family Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Cancer Center', 'investigatorFullName': 'Chao Family Comprehensive Cancer Center', 'investigatorAffiliation': 'University of California, Irvine'}}}}