Viewing Study NCT03298451

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Ignite Creation Date: 2025-12-24 @ 11:55 PM
Ignite Modification Date: 2026-01-04 @ 5:45 AM
Study NCT ID: NCT03298451
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-10-15
First Post: 2017-09-19
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'C520704', 'term': 'tremelimumab'}, {'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1 8772409479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca Clinical Study Information Center'}, 'certainAgreement': {'otherDetails': 'Investigator agrees not to independently publish the results of the Study until first occurrence of one of the following: (i) multi-centre primary Publication is published; (ii) no multi-centre primary publication is submitted within two years after conclusion, abandonment, or termination of the Study at all sites; or (iii) Sponsor confirms in writing there will be no multi-centre primary Publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.', 'eventGroups': [{'id': 'EG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)', 'otherNumAtRisk': 388, 'deathsNumAtRisk': 389, 'otherNumAffected': 299, 'seriousNumAtRisk': 388, 'deathsNumAffected': 280, 'seriousNumAffected': 115}, {'id': 'EG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W', 'otherNumAtRisk': 388, 'deathsNumAtRisk': 393, 'otherNumAffected': 334, 'seriousNumAtRisk': 388, 'deathsNumAffected': 262, 'seriousNumAffected': 157}, {'id': 'EG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 153, 'otherNumAffected': 133, 'seriousNumAtRisk': 152, 'deathsNumAffected': 123, 'seriousNumAffected': 52}, {'id': 'EG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)', 'otherNumAtRisk': 374, 'deathsNumAtRisk': 389, 'otherNumAffected': 333, 'seriousNumAtRisk': 374, 'deathsNumAffected': 293, 'seriousNumAffected': 111}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 49, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 45, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 26, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 38, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 63, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 53, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 33, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 32, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 24, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 38, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 58, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 69, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 72, 'numAffected': 67}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 35, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 29, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 39, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 32, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 44, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 34, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 54, 'numAffected': 53}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 197, 'numAffected': 173}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 61, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 106, 'numAffected': 89}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 51, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 101, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 54, 'numAffected': 50}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 79, 'numAffected': 68}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 48, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 45, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 36, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 67, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 125, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 39, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 241, 'numAffected': 164}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 37, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 63, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 46, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 49, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 49, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 71, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 31, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 75, 'numAffected': 70}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 38, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 62, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 34, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 37, 'numAffected': 36}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 46, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 38, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 36, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 46, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 72, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 41, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 53, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 61, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 36, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Haemophagocytic lymphohistiocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Autoimmune hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bile duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Biliary obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 388, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.56', 'groupId': 'OG000', 'lowerLimit': '14.06', 'upperLimit': '19.12'}, {'value': '16.43', 'groupId': 'OG001', 'lowerLimit': '14.16', 'upperLimit': '19.58'}, {'value': '16.36', 'groupId': 'OG002', 'lowerLimit': '12.39', 'upperLimit': '19.65'}, {'value': '13.77', 'groupId': 'OG003', 'lowerLimit': '12.25', 'upperLimit': '16.13'}]}]}], 'analyses': [{'pValue': '0.0035', 'groupIds': ['OG001', 'OG003'], 'pValueComment': "The adjusted alpha levels (0.0398) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.", 'groupDescription': 'The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.92', 'groupDescription': 'The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).', 'description': 'OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This primary outcome measure presents OS analysis of Treme 300mg x1 dose + Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who were randomized. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.56', 'groupId': 'OG000', 'lowerLimit': '14.06', 'upperLimit': '19.12'}, {'value': '16.43', 'groupId': 'OG001', 'lowerLimit': '14.16', 'upperLimit': '19.58'}, {'value': '16.36', 'groupId': 'OG002', 'lowerLimit': '12.39', 'upperLimit': '19.65'}, {'value': '13.77', 'groupId': 'OG003', 'lowerLimit': '12.25', 'upperLimit': '16.13'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.67', 'paramValue': '0.86', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.03', 'estimateComment': "The 95.67% confidence interval were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.", 'groupDescription': 'The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-interiority for the comparison of arm Durva 1500 mg vs Sora 400 mg is declared if the upper limit of the two-sided alpha adjusted CI for HR is less than the NI margin of 1.08.'}, {'pValue': '0.0674', 'groupIds': ['OG000', 'OG003'], 'pValueComment': "The adjusted alpha levels (0.0433) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.", 'groupDescription': 'The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority was tested sequentially per protocol as non-inferiority was satisfied.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).', 'description': 'OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This secondary outcome measure presents OS analysis of Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who were randomized. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) at 18, 24, and 36 Months After Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'title': 'Survival rate at 18 months', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000', 'lowerLimit': '42.4', 'upperLimit': '52.3'}, {'value': '48.7', 'groupId': 'OG001', 'lowerLimit': '43.6', 'upperLimit': '53.5'}, {'value': '46.4', 'groupId': 'OG002', 'lowerLimit': '38.4', 'upperLimit': '54.1'}, {'value': '41.5', 'groupId': 'OG003', 'lowerLimit': '36.5', 'upperLimit': '46.4'}]}]}, {'title': 'Survival rate at 24 months', 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '44.5'}, {'value': '40.5', 'groupId': 'OG001', 'lowerLimit': '35.6', 'upperLimit': '45.3'}, {'value': '37.3', 'groupId': 'OG002', 'lowerLimit': '29.6', 'upperLimit': '44.9'}, {'value': '32.6', 'groupId': 'OG003', 'lowerLimit': '27.9', 'upperLimit': '37.4'}]}]}, {'title': 'Survival rate at 36 months', 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '29.8'}, {'value': '30.7', 'groupId': 'OG001', 'lowerLimit': '25.8', 'upperLimit': '35.7'}, {'value': '22.9', 'groupId': 'OG002', 'lowerLimit': '16.6', 'upperLimit': '29.8'}, {'value': '20.2', 'groupId': 'OG003', 'lowerLimit': '15.8', 'upperLimit': '25.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).', 'description': 'Percentage of participants who were alive at fixed time points (18, 24, and 36 months) after randomization. The estimated percentage of survival along with the 95% confidence interval were calculated using Kaplan-Meier technique on the full analysis set.', 'unitOfMeasure': 'percentage of survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who were randomized. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.65', 'groupId': 'OG000', 'lowerLimit': '3.19', 'upperLimit': '3.75'}, {'value': '3.78', 'groupId': 'OG001', 'lowerLimit': '3.68', 'upperLimit': '5.32'}, {'value': '3.65', 'groupId': 'OG002', 'lowerLimit': '2.79', 'upperLimit': '4.86'}, {'value': '4.07', 'groupId': 'OG003', 'lowerLimit': '3.75', 'upperLimit': '5.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor scans performed at baseline, every 8 weeks for the first 48 weeks following randomization, and every 12 weeks thereafter until RECIST 1.1-defined progression. Assessed up to DCO (27Aug2021, to a maximum of approximately 46 months)', 'description': 'PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 \\[RECIST 1.1\\] using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death by any cause in the absence of progression, regardless of whether the patient withdrew from study treatment or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as a at least 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who were randomized. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Time To Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.75', 'groupId': 'OG000', 'lowerLimit': '3.68', 'upperLimit': '5.42'}, {'value': '5.42', 'groupId': 'OG001', 'lowerLimit': '3.81', 'upperLimit': '5.62'}, {'value': '3.75', 'groupId': 'OG002', 'lowerLimit': '3.55', 'upperLimit': '5.59'}, {'value': '5.55', 'groupId': 'OG003', 'lowerLimit': '5.13', 'upperLimit': '5.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'TTP was defined as the time from randomization until objective tumor progression in the absence of death. If participants died without tumor progression, they were censored at the time of death.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who were randomized. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'ORR (per RECIST 1.1 as assessed by the Investigator) was defined as the number (%) of participants with at least 1 confirmed visit response of CR or PR until progression, or the last evaluable assessment in the absence of progression. Participants who go off treatment without progression, receive a subsequent therapy, and then respond will not be included as responders in the ORR. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \\<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who were randomized. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '236', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the date of randomization until objective tumor progression or date of death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'Number (%) of participants with a Best Objective Response (BoR) of CR, PR, or SD. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \\<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (ie., SD) was defined as neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increase to qualify for progression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who were randomized. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'title': 'Duration of response from onset of response', 'categories': [{'measurements': [{'value': '16.82', 'comment': 'Not reached', 'groupId': 'OG000', 'lowerLimit': '7.43', 'upperLimit': 'NA'}, {'value': '22.34', 'comment': 'Not reached', 'groupId': 'OG001', 'lowerLimit': '8.54', 'upperLimit': 'NA'}, {'value': '14.75', 'groupId': 'OG002', 'lowerLimit': '7.46', 'upperLimit': '14.75'}, {'value': '18.43', 'groupId': 'OG003', 'lowerLimit': '6.51', 'upperLimit': '25.99'}]}]}, {'title': 'Time to onset of response from randomization', 'categories': [{'measurements': [{'value': '2.09', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '3.98'}, {'value': '2.17', 'groupId': 'OG001', 'lowerLimit': '1.84', 'upperLimit': '3.98'}, {'value': '2.02', 'groupId': 'OG002', 'lowerLimit': '1.87', 'upperLimit': '3.71'}, {'value': '3.78', 'groupId': 'OG003', 'lowerLimit': '1.89', 'upperLimit': '8.44'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first documented response until the first date of documented progression or death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'Time from the date of first documented confirmed response (complete or partial response) until the first date of documented progression or death in the absence of disease progression. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \\<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of FAS subjects who achieve confirmed CR or PR as determined per RECIST 1.1 using Investigator assessment. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) by PD-L1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '329', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'title': 'PD-L1 expression positive (TIP>=1%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '148', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.22', 'groupId': 'OG000', 'lowerLimit': '12.29', 'upperLimit': '24.38'}, {'value': '17.00', 'groupId': 'OG001', 'lowerLimit': '13.11', 'upperLimit': '22.31'}, {'value': '24.21', 'groupId': 'OG002', 'lowerLimit': '14.55', 'upperLimit': '27.24'}, {'value': '15.93', 'groupId': 'OG003', 'lowerLimit': '10.68', 'upperLimit': '21.72'}]}]}, {'title': 'PD-L1 expression negative (TIP<1%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '181', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.06', 'groupId': 'OG000', 'lowerLimit': '12.68', 'upperLimit': '18.53'}, {'value': '14.26', 'groupId': 'OG001', 'lowerLimit': '11.50', 'upperLimit': '21.29'}, {'value': '14.46', 'groupId': 'OG002', 'lowerLimit': '8.97', 'upperLimit': '17.51'}, {'value': '13.93', 'groupId': 'OG003', 'lowerLimit': '12.39', 'upperLimit': '16.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until death due to any cause, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'Overall survival by baseline PD-L1 expression levels (positive vs. negative). PD-L1 expression level is based on the Tumor and Immune Cell Positivity (TIP) score method as: PD-L1 Positive (TIP ≥ 1%) or PD-L1 Negative (TIP \\< 1%).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of FAS who had non-missing baseline PD-L1 status. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '323', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '5.68', 'upperLimit': '9.33'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '5.82', 'upperLimit': '10.84'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '5.65', 'upperLimit': '9.33'}, {'value': '5.7', 'groupId': 'OG003', 'lowerLimit': '4.80', 'upperLimit': '7.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.', 'description': 'European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30), which consists of 30 questions combined to produce a global health status/QoL scale. Higher scores indicate better health. A clinically meaningful deterioration is defined as a decrease in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of the FAS who had baseline scores of \\>=10. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '314', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '9.46', 'upperLimit': '24.41'}, {'value': '16.8', 'comment': 'Not reached', 'groupId': 'OG001', 'lowerLimit': '11.17', 'upperLimit': 'NA'}, {'value': '14.7', 'groupId': 'OG002', 'lowerLimit': '8.97', 'upperLimit': '36.04'}, {'value': '8.9', 'groupId': 'OG003', 'lowerLimit': '7.23', 'upperLimit': '11.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.', 'description': 'EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of the FAS who have a baseline symptom score \\<= 90. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '309', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '9.03', 'upperLimit': '22.31'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '9.23', 'upperLimit': '19.58'}, {'value': '13.8', 'groupId': 'OG002', 'lowerLimit': '6.47', 'upperLimit': '19.19'}, {'value': '9.4', 'groupId': 'OG003', 'lowerLimit': '7.46', 'upperLimit': '13.37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.', 'description': 'EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of the FAS who have a baseline symptom score \\<= 90. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'EORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '319', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '9.46', 'upperLimit': '24.8'}, {'value': '20.9', 'groupId': 'OG001', 'lowerLimit': '12.88', 'upperLimit': '36.01'}, {'value': '11.3', 'groupId': 'OG002', 'lowerLimit': '5.78', 'upperLimit': '19.19'}, {'value': '11.1', 'groupId': 'OG003', 'lowerLimit': '9.26', 'upperLimit': '13.73'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.', 'description': 'EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of the FAS who have a baseline symptom score \\<= 90. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Presence of ADA for Durvalumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'title': 'Treatment-emergent ADA positive (ADA Incidence)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-induced ADA (Positive Post-baseline only)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of durvalumab. Assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'Number of participants with Anti-Drug Antibody (ADA) response to Durvalumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Durvalumab for each indicated category.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Durvalumab ADA evaluable set includes all participants who received at least 1 dose of Durvalumab and had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results for Durvalumab. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Presence of ADA for Tremelimumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'title': 'Treatment-emergent ADA positive (ADA Incidence)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-induced ADA (Positive Post-baseline only)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of tremelimumab. Assessed up to approximately 46 months after the first randomization.', 'description': 'Number of participants with Anti-Drug Antibody (ADA) response to Tremelimumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Tremelimumab for each indicated category.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Tremelimumab ADA evaluable set includes all participants who received at least 1 dose of Tremelimumab and had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results for Tremelimumab. T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Summary of Durvalumab Concentration Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'title': 'Cycle 2 (Week 4) pre-dose, Geometric mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '74.7', 'spread': '86.7', 'groupId': 'OG000'}, {'value': '59.9', 'spread': '101.6', 'groupId': 'OG001'}, {'value': '65.1', 'spread': '68.4', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 4 (Week 12) pre-dose, Geometric mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '113.9', 'spread': '116.2', 'groupId': 'OG000'}, {'value': '77.5', 'spread': '280.1', 'groupId': 'OG001'}, {'value': '92.1', 'spread': '137.5', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 4 (Week 12) post-dose, Geometric mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '556.9', 'spread': '32.7', 'groupId': 'OG000'}, {'value': '539.3', 'spread': '38.6', 'groupId': 'OG001'}, {'value': '528.4', 'spread': '36.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'To evaluate the PK of Durvalumab, samples were collected pre-dose at week 4 and week 12 and post-dose at week 12. Assessed at the final analysis DCO (27Aug2021).', 'description': 'Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported over time.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set includes all participants who received at least 1 dose Durvalumab per the study protocol for whom any PK post-dose data were available (ie, at least 1 non-missing post-dose PK result). T75+D arm was closed during study.'}, {'type': 'SECONDARY', 'title': 'Summary of Tremelimumab Concentration Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'OG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'OG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'OG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'classes': [{'title': 'Cycle 1 (Week 0) post-dose, Geometric mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.0', 'spread': '117.2', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 (Week 4), Geometric mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '84.7', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '67.8', 'groupId': 'OG002'}]}]}, {'title': 'Cycle 4 (Week 12), Geometric mean', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '156.5', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '85.4', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'To evaluate the PK of Tremelimumab, samples were collected at week 0 (post-dose), week 4, and week 12. Assessed at the final analysis DCO (27Aug2021).', 'description': 'Blood sample were collected at pre-specified timepoints and Tremelimumab concentrations in serum (ug/mL) were reported over time.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set includes all participants who received at least 1 dose of Tremelimumab per the study protocol for whom any PK post-dose data were available (ie, at least 1 non-missing post-dose PK result). T75+D arm was closed during study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'FG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'FG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'FG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '389'}, {'groupId': 'FG001', 'numSubjects': '393'}, {'groupId': 'FG002', 'numSubjects': '153'}, {'groupId': 'FG003', 'numSubjects': '389'}]}, {'type': 'Received Treatment', 'comment': "One participant in T300+D and one in T75+D arm didn't receive Treme and were analyzed under the Durva mono arm in the safety analysis set", 'achievements': [{'groupId': 'FG000', 'numSubjects': '386'}, {'groupId': 'FG001', 'numSubjects': '389'}, {'groupId': 'FG002', 'numSubjects': '153'}, {'groupId': 'FG003', 'numSubjects': '374'}]}, {'type': 'COMPLETED', 'comment': 'Completed final analysis and ongoing in long-term follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '125'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '285'}, {'groupId': 'FG001', 'numSubjects': '268'}, {'groupId': 'FG002', 'numSubjects': '123'}, {'groupId': 'FG003', 'numSubjects': '307'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '260'}, {'groupId': 'FG002', 'numSubjects': '122'}, {'groupId': 'FG003', 'numSubjects': '280'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'The study includes 1324 participants. Participants were screened in 16 countries from Oct2017 to Jun2019. Recruitment in T75+D arm was closed during the study. Results are reported at data cut-off (DCO).', 'preAssignmentDetails': 'Of 1,950 participants screened in the study, 1,324 were randomized across 4 arms, out of which 1,302 participants received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '393', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '389', 'groupId': 'BG003'}, {'value': '1324', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Durva 1500 mg', 'description': 'Durvalumab 1500 mg every 4 weeks (Q4W)'}, {'id': 'BG001', 'title': 'Treme 300 mg x1 Dose + Durva 1500 mg', 'description': 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W'}, {'id': 'BG002', 'title': 'Treme 75 mg x4 Doses + Durva 1500 mg', 'description': 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W'}, {'id': 'BG003', 'title': 'Sora 400 mg', 'description': 'Sorafenib 400 mg twice daily (BID)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.6', 'spread': '11.47', 'groupId': 'BG000'}, {'value': '63.0', 'spread': '11.65', 'groupId': 'BG001'}, {'value': '63.4', 'spread': '12.03', 'groupId': 'BG002'}, {'value': '63.5', 'spread': '11.12', 'groupId': 'BG003'}, {'value': '63.1', 'spread': '11.48', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65', 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}, {'value': '667', 'groupId': 'BG004'}]}]}, {'title': '>=65-<75', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}, {'value': '467', 'groupId': 'BG004'}]}]}, {'title': '>=75', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '190', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '216', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '327', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '337', 'groupId': 'BG003'}, {'value': '1108', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}, {'value': '591', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}, {'value': '671', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '376', 'groupId': 'BG000'}, {'value': '372', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '362', 'groupId': 'BG003'}, {'value': '1252', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region group', 'classes': [{'title': 'Asia (except Japan)', 'categories': [{'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '539', 'groupId': 'BG004'}]}]}, {'title': 'Rest of World (includes Japan)', 'categories': [{'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}, {'value': '785', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) included all participants who were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-17', 'size': 12181679, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_016.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T09:47', 'hasProtocol': True}, {'date': '2021-07-30', 'size': 2676271, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_017.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-26T08:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1324}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2017-09-19', 'resultsFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2017-09-26', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-06-14', 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg', 'timeFrame': 'From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).', 'description': 'OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This primary outcome measure presents OS analysis of Treme 300mg x1 dose + Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg', 'timeFrame': 'From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).', 'description': 'OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This secondary outcome measure presents OS analysis of Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).'}, {'measure': 'Overall Survival (OS) at 18, 24, and 36 Months After Randomization', 'timeFrame': 'At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).', 'description': 'Percentage of participants who were alive at fixed time points (18, 24, and 36 months) after randomization. The estimated percentage of survival along with the 95% confidence interval were calculated using Kaplan-Meier technique on the full analysis set.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Tumor scans performed at baseline, every 8 weeks for the first 48 weeks following randomization, and every 12 weeks thereafter until RECIST 1.1-defined progression. Assessed up to DCO (27Aug2021, to a maximum of approximately 46 months)', 'description': 'PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 \\[RECIST 1.1\\] using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death by any cause in the absence of progression, regardless of whether the patient withdrew from study treatment or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as a at least 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir.'}, {'measure': 'Time To Progression (TTP)', 'timeFrame': 'From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'TTP was defined as the time from randomization until objective tumor progression in the absence of death. If participants died without tumor progression, they were censored at the time of death.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'ORR (per RECIST 1.1 as assessed by the Investigator) was defined as the number (%) of participants with at least 1 confirmed visit response of CR or PR until progression, or the last evaluable assessment in the absence of progression. Participants who go off treatment without progression, receive a subsequent therapy, and then respond will not be included as responders in the ORR. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \\<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'From the date of randomization until objective tumor progression or date of death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'Number (%) of participants with a Best Objective Response (BoR) of CR, PR, or SD. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \\<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (ie., SD) was defined as neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increase to qualify for progression.'}, {'measure': 'Duration of Objective Response (DoR)', 'timeFrame': 'From the date of first documented response until the first date of documented progression or death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'Time from the date of first documented confirmed response (complete or partial response) until the first date of documented progression or death in the absence of disease progression. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \\<10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.'}, {'measure': 'Overall Survival (OS) by PD-L1', 'timeFrame': 'From the date of randomization until death due to any cause, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'Overall survival by baseline PD-L1 expression levels (positive vs. negative). PD-L1 expression level is based on the Tumor and Immune Cell Positivity (TIP) score method as: PD-L1 Positive (TIP ≥ 1%) or PD-L1 Negative (TIP \\< 1%).'}, {'measure': 'EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration', 'timeFrame': 'At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.', 'description': 'European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30), which consists of 30 questions combined to produce a global health status/QoL scale. Higher scores indicate better health. A clinically meaningful deterioration is defined as a decrease in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.'}, {'measure': 'EORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration', 'timeFrame': 'At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.', 'description': 'EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.'}, {'measure': 'EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration', 'timeFrame': 'At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.', 'description': 'EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.'}, {'measure': 'EORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration', 'timeFrame': 'At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.', 'description': 'EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.'}, {'measure': 'Presence of ADA for Durvalumab', 'timeFrame': 'Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of durvalumab. Assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).', 'description': 'Number of participants with Anti-Drug Antibody (ADA) response to Durvalumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Durvalumab for each indicated category.'}, {'measure': 'Presence of ADA for Tremelimumab', 'timeFrame': 'Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of tremelimumab. Assessed up to approximately 46 months after the first randomization.', 'description': 'Number of participants with Anti-Drug Antibody (ADA) response to Tremelimumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Tremelimumab for each indicated category.'}, {'measure': 'Summary of Durvalumab Concentration Over Time', 'timeFrame': 'To evaluate the PK of Durvalumab, samples were collected pre-dose at week 4 and week 12 and post-dose at week 12. Assessed at the final analysis DCO (27Aug2021).', 'description': 'Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported over time.'}, {'measure': 'Summary of Tremelimumab Concentration Over Time', 'timeFrame': 'To evaluate the PK of Tremelimumab, samples were collected at week 0 (post-dose), week 4, and week 12. Assessed at the final analysis DCO (27Aug2021).', 'description': 'Blood sample were collected at pre-specified timepoints and Tremelimumab concentrations in serum (ug/mL) were reported over time.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma Non-Resectable'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '40222621', 'type': 'DERIVED', 'citation': 'Rimassa L, Chan SL, Sangro B, Lau G, Kudo M, Reig M, Breder V, Ryu MH, Ostapenko Y, Sukeepaisarnjaroen W, Varela M, Tougeron D, Crysler OV, Bouattour M, Van Dao T, Tam VC, Faccio A, Furuse J, Jeng LB, Kang YK, Kelley RK, Paskow MJ, Ran D, Xynos I, Kurland JF, Negro A, Abou-Alfa GK. Five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable HCC. J Hepatol. 2025 Oct;83(4):899-908. doi: 10.1016/j.jhep.2025.03.033. Epub 2025 Apr 11.'}, {'pmid': '39089633', 'type': 'DERIVED', 'citation': 'Lau G, Abou-Alfa GK, Cheng AL, Sukeepaisarnjaroen W, Van Dao T, Kang YK, Thungappa SC, Kudo M, Sangro B, Kelley RK, Furuse J, Park JW, Sunpaweravong P, Fasolo A, Yau T, Kawaoka T, Azevedo S, Reig M, Assenat E, Yarchoan M, He AR, Makowsky M, Gupta C, Negro A, Chan SL. Outcomes in the Asian subgroup of the phase III randomised HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma. J Hepatol. 2025 Feb;82(2):258-267. doi: 10.1016/j.jhep.2024.07.017. Epub 2024 Jul 31.'}, {'pmid': '38805668', 'type': 'DERIVED', 'citation': 'Sangro B, Galle PR, Kelley RK, Charoentum C, De Toni EN, Ostapenko Y, Heo J, Cheng AL, Wilson Woods A, Gupta C, Abraham J, McCoy CL, Patel N, Negro A, Vogel A, Abou-Alfa GK. Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2024 Aug 10;42(23):2790-2799. doi: 10.1200/JCO.23.01462. Epub 2024 May 28.'}, {'pmid': '38319892', 'type': 'DERIVED', 'citation': 'Abou-Alfa GK, Lau G, Kudo M, Chan SL, Kelley RK, Furuse J, Sukeepaisarnjaroen W, Kang YK, Van Dao T, De Toni EN, Rimassa L, Breder V, Vasilyev A, Heurgue A, Tam VC, Mody K, Thungappa SC, Ostapenko Y, Yau T, Azevedo S, Varela M, Cheng AL, Qin S, Galle PR, Ali S, Marcovitz M, Makowsky M, He P, Kurland JF, Negro A, Sangro B. Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma. NEJM Evid. 2022 Aug;1(8):EVIDoa2100070. doi: 10.1056/EVIDoa2100070. Epub 2022 Jun 6.'}, {'pmid': '37678916', 'type': 'DERIVED', 'citation': 'Addendum 1: Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of hepatocellular carcinoma. J Immunother Cancer. 2023 Sep;11(9):e002794add1. doi: 10.1136/jitc-2021-002794add1. No abstract available.'}, {'pmid': '37676259', 'type': 'DERIVED', 'citation': 'Patel TH, Brewer JR, Fan J, Cheng J, Shen YL, Xiang Y, Zhao H, Lemery SJ, Pazdur R, Kluetz PG, Fashoyin-Aje LA. FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma. Clin Cancer Res. 2024 Jan 17;30(2):269-273. doi: 10.1158/1078-0432.CCR-23-2124.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D419CC00002&amp;attachmentIdentifier=5492a658-0cae-4a53-9c5f-2c7d7dd2f180&amp;fileName=419CC00002CSP_redacted.pdf&amp;versionIdentifier=', 'label': 'CSP\\_redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D419CC00002&amp;attachmentIdentifier=dfa10daf-41b0-454d-ab99-f62959a00fdc&amp;fileName=D419CC00002_SAP_redacted.pdf&amp;versionIdentifier=', 'label': 'SAP\\_redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D419CC00002&amp;attachmentIdentifier=7f90991f-10dd-4176-8b36-c5535f3ba6d6&amp;fileName=D419CC00002_CSR__synopsis_redacted.pdf&amp;versionIdentifier=', 'label': 'CSR\\_synopsis'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy', 'detailedDescription': "The study population includes patients 18 years of age or older with advanced HCC, Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease. Patients must not have received any prior systemic therapy for unresectable HCC.\n\nPatients in all treatment arms may continue receiving their originally assigned treatment, at the Investigator's discretion, until progression\n\nPatients in all arms with confirmed PD who, in the Investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of PD may continue to receive their assigned treatment.\n\nIf a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumor assessments until confirmed PD and will be followed for survival"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* HCC based on histopathological confirmation\n* No prior systemic therapy for HCC\n* Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C\n* Child-Pugh Score class A\n* ECOG performance status of 0 or 1 at enrollment\n\nExclusion criteria\n\n* Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy\n* Clinically meaningful ascites\n* Main portal vein tumor thrombosis\n* Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months\n* HBV and HVC co-infection, or HBV and Hep D co-infection'}, 'identificationModule': {'nctId': 'NCT03298451', 'acronym': 'HIMALAYA', 'briefTitle': 'Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'D419CC00002'}, 'secondaryIdInfos': [{'id': '2024-512212-21-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}, {'id': '2016-005126-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Durvalumab', 'interventionNames': ['Drug: Durvalumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Durvalumab in combination with tremelimumab (Regimen 1)', 'interventionNames': ['Drug: Tremelimumab (Regimen 1)', 'Drug: Durvalumab (Regimen 1)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Durvalumab in combination with tremelimumab (Regimen 2)', 'interventionNames': ['Drug: Tremelimumab (Regimen 2)', 'Drug: Durvalumab (Regimen 2)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4', 'description': 'Sorafenib', 'interventionNames': ['Drug: Sorafenib']}], 'interventions': [{'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['MEDI4736'], 'description': 'Durvalumab IV (intravenous infusion).', 'armGroupLabels': ['Arm 1']}, {'name': 'Tremelimumab (Regimen 1)', 'type': 'DRUG', 'description': 'Tremelimumab IV (intravenous infusion).', 'armGroupLabels': ['Arm 2']}, {'name': 'Tremelimumab (Regimen 2)', 'type': 'DRUG', 'description': 'Tremelimumab IV (intravenous infusion).', 'armGroupLabels': ['Arm 3']}, {'name': 'Sorafenib', 'type': 'DRUG', 'description': 'Sorafenib, as per standard of care', 'armGroupLabels': ['Arm 4']}, {'name': 'Durvalumab (Regimen 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