Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-05 @ 5:19 PM
Study NCT ID:
NCT02960204
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005234', 'term': 'Fatty Liver'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C487112', 'term': '3-(2-(2-tert-butylphenylaminooxalyl)aminopropionylamino)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mhubka@histogen.com', 'phone': '858-526-3109', 'title': 'Mark Hubka, Executive Director, Medical Affairs', 'organization': 'Histogen Inc.'}, 'certainAgreement': {'otherDetails': 'Any publication or discussion must be approved by the Sponsor prior to release.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First day of study treatment through the follow-up phase (Week 28 for participants who received treatment through Week 24 OR Week 50 for participants who received treatment through Week 48).', 'description': "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.", 'eventGroups': [{'id': 'EG000', 'title': 'Emricasan (5 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.\n\nEmricasan', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 59, 'seriousNumAtRisk': 65, 'deathsNumAffected': 1, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Emricasan (25 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.\n\nEmricasan', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 62, 'seriousNumAtRisk': 65, 'deathsNumAffected': 2, 'seriousNumAffected': 23}, {'id': 'EG002', 'title': 'Emricasan (50 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.\n\nEmricasan', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 57, 'seriousNumAtRisk': 66, 'deathsNumAffected': 1, 'seriousNumAffected': 21}, {'id': 'EG003', 'title': 'Matching Placebo', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.\n\nPlacebo', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 61, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Gastrointestinal disorders', 'notes': 'Abdominal pain, ascites, colitis, constipation, diarrhoea, intestinal diverticulum, dyspepsia, gastric ulcer, gastritis, GERD, haematemesis, nausea, oesophageal varices haemorrhage, vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pneumonia', 'notes': 'Acute sinusitis, bacteremia, bronchitis, cellulitis, influenza, kidney infection, gastroenteritis, nasopharyngitis, pneumonia, respiratory tract infection, sepsis, urinary tract infection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hepatocellular carcinoma', 'notes': 'Hepatocellular carcinoma, Hepatic neoplasm, Breast cancer, colon cancer, prostate cancer, renal cancer, squamous cell carcinoma.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hepatic encephalopathy', 'notes': 'Asterixis, Dysarthria, Guillain-Barre Syndrome, Headache, Hepatic encephalopathy, Migraine, neuralgia, paraesthesia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Acute kidney injury', 'notes': 'Acute kidney injury, Haemorrhagic cystitis, haematuria, nephrolithiasis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 67, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Esophageal varices hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pruritus generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 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0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Retroperitoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Urinary retention postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypervolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Breast cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hepatocellular cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Subarachnoid hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hepatic hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Porto pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Rash generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Hepatic Venous Pressure Gradient (HVPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Emricasan (5 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.\n\nEmricasan'}, {'id': 'OG001', 'title': 'Emricasan (25 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.\n\nEmricasan'}, {'id': 'OG002', 'title': 'Emricasan (50 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.\n\nEmricasan'}, {'id': 'OG003', 'title': 'Matching Placebo', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.48', 'spread': '3.356', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '3.669', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '3.400', 'groupId': 'OG002'}, {'value': '-0.18', 'spread': '3.028', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'To assess the mean change from baseline to Week 24 in hepatic venous pressure gradient (HVPG)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (Multiple Imputation)'}, {'type': 'SECONDARY', 'title': 'Improvement of HVPG Response Using a 20% Reduction From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Emricasan (5 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.\n\nEmricasan'}, {'id': 'OG001', 'title': 'Emricasan (25 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.\n\nEmricasan'}, {'id': 'OG002', 'title': 'Emricasan (50 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.\n\nEmricasan'}, {'id': 'OG003', 'title': 'Matching Placebo', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.\n\nPlacebo'}], 'classes': [{'title': '>= 20% reduction in HVPG: Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': '>= 20% Reduction in HVPG: No', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'To assess subjects who have at least a 20 percent reduction from baseline in HVPG', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Caspase 3/7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Emricasan (5 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.\n\nEmricasan'}, {'id': 'OG001', 'title': 'Emricasan (25 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.\n\nEmricasan'}, {'id': 'OG002', 'title': 'Emricasan (50 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.\n\nEmricasan'}, {'id': 'OG003', 'title': 'Matching Placebo', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.\n\nPlacebo'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.475', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.597', 'groupId': 'OG001'}, {'value': '-0.46', 'spread': '0.663', 'groupId': 'OG002'}, {'value': '-0.04', 'spread': '0.339', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.541', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.665', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.564', 'groupId': 'OG002'}, {'value': '0.05', 'spread': '0.373', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24, Baseline to Week 48', 'description': 'To assess whether number of Caspase 3/7 biomarkers is affected by emricasan as compared to placebo', 'unitOfMeasure': 'RLU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Observed Cases)'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Emricasan (5 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.\n\nEmricasan'}, {'id': 'OG001', 'title': 'Emricasan (25 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.\n\nEmricasan'}, {'id': 'OG002', 'title': 'Emricasan (50 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.\n\nEmricasan'}, {'id': 'OG003', 'title': 'Matching Placebo', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.\n\nPlacebo'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.83', 'spread': '10.650', 'groupId': 'OG000'}, {'value': '-8.06', 'spread': '10.542', 'groupId': 'OG001'}, {'value': '-7.06', 'spread': '12.010', 'groupId': 'OG002'}, {'value': '-1.69', 'spread': '12.907', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.54', 'spread': '11.917', 'groupId': 'OG000'}, {'value': '-4.16', 'spread': '9.850', 'groupId': 'OG001'}, {'value': '-5.34', 'spread': '11.153', 'groupId': 'OG002'}, {'value': '-2.97', 'spread': '12.457', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24 and Baseline to Week 48', 'description': 'To assess whether amount of non-specific (ALT) biomarkers are affected by emricasan compared to placebo', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Observed Cases)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Emricasan (5 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.\n\nEmricasan'}, {'id': 'FG001', 'title': 'Emricasan (25 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.\n\nEmricasan'}, {'id': 'FG002', 'title': 'Emricasan (50 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.\n\nEmricasan'}, {'id': 'FG003', 'title': 'Matching Placebo', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '67'}]}, {'type': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'groupId': 'FG003', 'numSubjects': '67'}]}, {'type': 'Completed Week 24 of Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '66'}]}, {'type': 'Completed Week 48 of Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'comment': 'Follow-Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '29'}]}]}], 'preAssignmentDetails': 'Enrolled participants were excluded from the study and not randomized if they withdrew consent or did not meet inclusion/exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Emricasan (5 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.\n\nEmricasan'}, {'id': 'BG001', 'title': 'Emricasan (25 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.\n\nEmricasan'}, {'id': 'BG002', 'title': 'Emricasan (50 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.\n\nEmricasan'}, {'id': 'BG003', 'title': 'Matching Placebo', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.\n\nPlacebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '60.6', 'spread': '8.77', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '8.81', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '9.48', 'groupId': 'BG002'}, {'value': '61.4', 'spread': '7.90', 'groupId': 'BG003'}, {'value': '60.8', 'spread': '8.76', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '150', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '191', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '240', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hepatic Venous Pressure Gradient', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '16.88', 'spread': '3.573', 'groupId': 'BG000'}, {'value': '17.25', 'spread': '3.300', 'groupId': 'BG001'}, {'value': '16.91', 'spread': '3.545', 'groupId': 'BG002'}, {'value': '16.81', 'spread': '3.724', 'groupId': 'BG003'}, {'value': '16.96', 'spread': '3.586', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Taking Non-Selective Beta Blockers at Baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '156', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cirrhosis Baseline Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Compensated Cirrhosis', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '201', 'groupId': 'BG004'}]}, {'title': 'Decompensated Cirrhosis', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Varices', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}, {'title': 'Present - Small', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}]}, {'title': 'Present - Medium', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}, {'title': 'Present - Large', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'Present - Not Specified', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Compensated Status with Varices', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '261', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Compensated with none/small varices', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '135', 'groupId': 'BG004'}]}, {'title': 'Compensated with medium/large varices', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}, {'title': 'Decompensated with none/small varices', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}, {'title': 'Decompensated with medium/large varices', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two subjects (one in 25 mg emricasan arm and one in placebo arm) did not have data available.'}, {'title': 'Model for End-Stage Liver Disease (MELD) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9.17', 'spread': '2.673', 'groupId': 'BG000'}, {'value': '9.06', 'spread': '2.200', 'groupId': 'BG001'}, {'value': '9.24', 'spread': '2.512', 'groupId': 'BG002'}, {'value': '8.40', 'spread': '2.511', 'groupId': 'BG003'}, {'value': '8.97', 'spread': '2.489', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Scores range from 6.0 to 40.0, and higher MELD scores indicate more severe disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'MELD Classification (Median Cut)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': '<= 8', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '138', 'groupId': 'BG004'}]}, {'title': '>= 9', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Scores range from 6.0 to 40.0, and higher MELD scores indicate more severe disease.', 'unitOfMeasure': 'Participants'}, {'title': 'MELD Component: Total Bilirubin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.514', 'groupId': 'BG000'}, {'value': '1.31', 'spread': '0.482', 'groupId': 'BG001'}, {'value': '1.39', 'spread': '0.725', 'groupId': 'BG002'}, {'value': '1.20', 'spread': '0.600', 'groupId': 'BG003'}, {'value': '1.29', 'spread': '0.696', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'MELD Component: Serum Creatine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.079', 'groupId': 'BG000'}, {'value': '1.01', 'spread': '0.053', 'groupId': 'BG001'}, {'value': '1.04', 'spread': '0.160', 'groupId': 'BG002'}, {'value': '1.02', 'spread': '0.086', 'groupId': 'BG003'}, {'value': '1.02', 'spread': '0.102', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'MELD Component: International Normalized Ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.167', 'groupId': 'BG000'}, {'value': '1.16', 'spread': '0.167', 'groupId': 'BG001'}, {'value': '1.16', 'spread': '0.115', 'groupId': 'BG002'}, {'value': '1.14', 'spread': '0.113', 'groupId': 'BG003'}, {'value': '1.16', 'spread': '0.128', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Patients are assigned a score from 6 to 40. Worst score of 6 equates to 90% 3-month survival rate, while a best score of 40 equates to 7% 3-month survival rate.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Child-Pugh Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '0.96', 'groupId': 'BG000'}, {'value': '5.5', 'spread': '0.69', 'groupId': 'BG001'}, {'value': '5.6', 'spread': '0.86', 'groupId': 'BG002'}, {'value': '5.4', 'spread': '0.75', 'groupId': 'BG003'}, {'value': '5.5', 'spread': '0.82', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Scores range from 5 to 15, and higher Child-Pugh scores indicate more severe disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Child-Pugh Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '261', 'groupId': 'BG004'}]}], 'categories': [{'title': 'A', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}, {'title': 'B', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'C', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Scores range from 5 to 15, and higher Child-Pugh scores indicate more severe disease. A = scores from 5 to 6; B = scores from 7 to 9; C = scores from 10 to 15.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two subjects (one in the 5 mg emricasan arm and one in the 25 mg emricasan arm) did not have data available.'}, {'title': 'Child-Pugh Component: Total Bilirubin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '242', 'groupId': 'BG004'}]}, {'title': '2', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Each component of the Child-Pugh scale is scored from 1 to 3, with 3 being the most severe.', 'unitOfMeasure': 'Participants'}, {'title': 'Child-Pugh Component: Total Albumin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '209', 'groupId': 'BG004'}]}, {'title': '2', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Each component of the Child-Pugh scale is scored from 1 to 3, with 3 being the most severe.', 'unitOfMeasure': 'Participants'}, {'title': 'Child-Pugh Component: Ascites', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '238', 'groupId': 'BG004'}]}, {'title': '2', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Each component of the Child-Pugh scale is scored from 1 to 3, with 3 being the most severe.', 'unitOfMeasure': 'Participants'}, {'title': 'Child-Pugh Component Hepatic Encephalopathy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '261', 'groupId': 'BG004'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Each component of the Child-Pugh scale is scored from 1 to 3, with 3 being the most severe.', 'unitOfMeasure': 'Participants'}, {'title': 'Child-Pugh Component: Prothrombin Time (or International Normalized Ratio)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '262', 'groupId': 'BG004'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '261', 'groupId': 'BG004'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Each component of the Child-Pugh scale is scored from 1 to 3, with 3 being the most severe.', 'unitOfMeasure': 'Participants', 'populationDescription': 'One subject in the 5 mg emricasan arm did not have data available.'}, {'title': 'Gallstones', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cholecystectomy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-14', 'size': 1564548, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-22T12:07', 'hasProtocol': True}, {'date': '2018-07-10', 'size': 593527, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-22T12:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2016-07-29', 'resultsFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-16', 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Hepatic Venous Pressure Gradient (HVPG)', 'timeFrame': 'Baseline to Week 24', 'description': 'To assess the mean change from baseline to Week 24 in hepatic venous pressure gradient (HVPG)'}], 'secondaryOutcomes': [{'measure': 'Improvement of HVPG Response Using a 20% Reduction From Baseline', 'timeFrame': 'Baseline to Week 24', 'description': 'To assess subjects who have at least a 20 percent reduction from baseline in HVPG'}, {'measure': 'Caspase 3/7', 'timeFrame': 'Baseline to Week 24, Baseline to Week 48', 'description': 'To assess whether number of Caspase 3/7 biomarkers is affected by emricasan as compared to placebo'}, {'measure': 'Alanine Aminotransferase (ALT)', 'timeFrame': 'Baseline to Week 24 and Baseline to Week 48', 'description': 'To assess whether amount of non-specific (ALT) biomarkers are affected by emricasan compared to placebo'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cirrhosis', 'Portal Hypertension', 'Non-alcoholic Steatohepatitis', 'Liver cirrhosis'], 'conditions': ['Cirrhosis', 'Portal Hypertension', 'Non-alcoholic Steatohepatitis']}, 'referencesModule': {'references': [{'pmid': '31870950', 'type': 'RESULT', 'citation': 'Garcia-Tsao G, Bosch J, Kayali Z, Harrison SA, Abdelmalek MF, Lawitz E, Satapathy SK, Ghabril M, Shiffman ML, Younes ZH, Thuluvath PJ, Berzigotti A, Albillos A, Robinson JM, Hagerty DT, Chan JL, Sanyal AJ; IDN-6556-14 Investigators(double dagger). Randomized placebo-controlled trial of emricasan for non-alcoholic steatohepatitis-related cirrhosis with severe portal hypertension. J Hepatol. 2020 May;72(5):885-895. doi: 10.1016/j.jhep.2019.12.010. Epub 2019 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects 18 years or older, able to provide written informed consent and able to understand and willing to comply with the requirements of the study.\n* Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)\n* Compensated cirrhosis OR Decompensated cirrhosis with no more than 1 prior significant decompensating event\n* Severe portal hypertension defined as HVPG ≥12 mmHg\n* Subjects who are on NSBB, nitrates, diuretics, lactulose, rifaximin, or statins must be on a stable dose for at least 3 months prior to Day 1\n* Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug\n\nExclusion Criteria:\n\n* Evidence of severe decompensation\n* Severe hepatic impairment defined as a Child-Pugh score ≥10\n* ALT (alanine transaminase) \\> 3 times upper limit of normal (ULN) or AST (aspartate transaminase) \\>5 times ULN during screening\n* Estimated creatinine clearance \\<30 mL/min\n* Prior transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure\n* Known portal vein thrombosis\n* Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy\n* Current use of medications that are considered inhibitors of OATP1B1 and OATP1B3 transporters\n* Alpha-fetoprotein \\>50 ng/mL\n* History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QTcF interval of \\>500 msec\n* History of or active malignancies, other than those successfully treated with curative intent and believed to be cured\n* Prior liver transplant\n* Change in diabetes medications or vitamin E within 3 months of screening\n* Uncontrolled diabetes mellitus (HbA1c \\>9%) within 3 months of screening\n* Significant systemic or major illness other than liver disease\n* HIV infection\n* Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening\n* If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding\n* Previous treatment with emricasan or active investigational medication (except methacetin) in a clinical trial within 3 months prior to Day 1'}, 'identificationModule': {'nctId': 'NCT02960204', 'acronym': 'ENCORE-PH', 'briefTitle': 'Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension', 'nctIdAliases': ['NCT04806750'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Histogen'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension', 'orgStudyIdInfo': {'id': 'IDN-6556-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Emricasan (5 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.', 'interventionNames': ['Drug: Emricasan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Emricasan (25 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.', 'interventionNames': ['Drug: Emricasan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Emricasan (50 mg)', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.', 'interventionNames': ['Drug: Emricasan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo', 'description': 'Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Emricasan', 'type': 'DRUG', 'armGroupLabels': ['Emricasan (25 mg)', 'Emricasan (5 mg)', 'Emricasan (50 mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Pasadena', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92377', 'city': 'Rialto', 'state': 'California', 'country': 'United States', 'facility': 'Rialto', 'geoPoint': {'lat': 34.1064, 'lon': 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