Viewing Study NCT02527434

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Ignite Creation Date: 2025-12-25 @ 2:17 AM
Ignite Modification Date: 2026-02-20 @ 12:29 PM
Study NCT ID: NCT02527434
Status: COMPLETED
Last Update Posted: 2023-11-15
First Post: 2015-08-12
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of Tremelimumab in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '+1 302 885 1180', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'Publication of any or all of the results of the Research by the PI requires prior written consent of the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from Day 1 (i.e. first dose) up until 90 days following the end of treatment in the tremelimumab monotherapy phase and the retreatment phase (up to a total of 15 months per treatment phase).', 'eventGroups': [{'id': 'EG000', 'title': 'UBC- Tremelimumab Monotherapy', 'description': 'Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 30, 'seriousNumAtRisk': 32, 'deathsNumAffected': 13, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'TNBC - Tremelimumab Monotherapy', 'description': 'Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'PDAC- Tremelimumab Monotherapy', 'description': 'Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 12, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'UBC - COMBO', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'TNBC - COMBO', 'description': 'Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'PDAC - COMBO', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'UBC- MEDI', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'PDAC - MEDI', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 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'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 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{'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - Tremelimumab Monotherapy', 'description': 'Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG001', 'title': 'TNBC - Tremelimumab Monotherapy', 'description': 'Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG002', 'title': 'PDAC - Tremelimumab Monotherapy', 'description': 'Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '36.4'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '38.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '16.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 12 months in the tremelimumab monotherapy phase', 'description': 'Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).'}, {'type': 'SECONDARY', 'title': 'Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - Tremelimumab Monotherapy', 'description': 'Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG001', 'title': 'TNBC - Tremelimumab Monotherapy', 'description': 'Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG002', 'title': 'PDAC - Tremelimumab Monotherapy', 'description': 'Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'DoR was not estimable in this cohort', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '12.9'}, {'value': 'NA', 'comment': 'DoR was not estimable in this cohort', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to 12 months in the tremelimumab monotherapy phase', 'description': 'DoR during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the progression-free survival (PFS) censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - Tremelimumab Monotherapy', 'description': 'Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG001', 'title': 'TNBC - Tremelimumab Monotherapy', 'description': 'Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG002', 'title': 'PDAC - Tremelimumab Monotherapy', 'description': 'Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}], 'classes': [{'title': 'DCR at 3 or 4 months', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '11.46', 'upperLimit': '43.40'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '38.48'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '16.84'}]}]}, {'title': 'DCR at 12 months', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000', 'lowerLimit': '9.28', 'upperLimit': '39.97'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '38.48'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '16.84'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 12 months in the tremelimumab monotherapy phase', 'description': 'DCR during the initial tremelimumab monotherapy phase was defined as the percentage of patients who had a best objective response (BoR) of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) and 12 months (all patients), or who had demonstrated stable disease (SD) for a minimum interval of 3, 4 or 12 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).'}, {'type': 'SECONDARY', 'title': 'Median PFS During Tremelimumab Monotherapy Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - Tremelimumab Monotherapy', 'description': 'Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG001', 'title': 'TNBC - Tremelimumab Monotherapy', 'description': 'Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG002', 'title': 'PDAC - Tremelimumab Monotherapy', 'description': 'Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.63', 'comment': 'The upper limit was not estimable in this cohort.', 'groupId': 'OG000', 'lowerLimit': '1.77', 'upperLimit': 'NA'}, {'value': '3.58', 'groupId': 'OG001', 'lowerLimit': '1.40', 'upperLimit': '4.04'}, {'value': '1.77', 'groupId': 'OG002', 'lowerLimit': '1.38', 'upperLimit': '2.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to 12 months in the tremelimumab monotherapy phase', 'description': 'PFS during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression. Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).'}, {'type': 'SECONDARY', 'title': 'Best Objective Response (BoR) During Tremelimumab Monotherapy Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - Tremelimumab Monotherapy', 'description': 'Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG001', 'title': 'TNBC - Tremelimumab Monotherapy', 'description': 'Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG002', 'title': 'PDAC - Tremelimumab Monotherapy', 'description': 'Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '91.7', 'groupId': 'OG001'}, {'value': '90.0', 'groupId': 'OG002'}]}]}, {'title': 'NE', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 12 months in the tremelimumab monotherapy phase', 'description': 'BoR during the initial tremelimumab monotherapy phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or not evaluable \\[NE\\]) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).'}, {'type': 'SECONDARY', 'title': 'Median Overall Survival (OS) During Tremelimumab Monotherapy Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - Tremelimumab Monotherapy', 'description': 'Patients with UBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG001', 'title': 'TNBC - Tremelimumab Monotherapy', 'description': 'Patients with TNBC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}, {'id': 'OG002', 'title': 'PDAC - Tremelimumab Monotherapy', 'description': 'Patients with PDAC were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.32', 'groupId': 'OG000', 'lowerLimit': '5.91', 'upperLimit': '24.61'}, {'value': '12.88', 'comment': 'Upper limit was not estimable in this cohort.', 'groupId': 'OG001', 'lowerLimit': '2.53', 'upperLimit': 'NA'}, {'value': '3.98', 'groupId': 'OG002', 'lowerLimit': '2.83', 'upperLimit': '5.13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to final data cut-off date', 'description': 'OS was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. OS is presented from start of tremelimumab monotherapy phase and includes the retreatment phase if the patient entered the corresponding treatment phase.\n\nMedian OS was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Confirmed Overall Response During Retreatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - COMBO', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG001', 'title': 'TNBC - COMBO', 'description': 'Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG002', 'title': 'PDAC - COMBO', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG003', 'title': 'UBC- MEDI', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'OG004', 'title': 'PDAC - MEDI', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '41.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '52.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 12 months in retreatment phase', 'description': 'ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR and was based on all treated patients who had measurable disease at baseline (Day 1) and who sequenced to durvalumab monotherapy (MEDI treatment phase) or durvalumab + tremelimumab combination therapy (COMBO treatment phase). 95% CIs were calculated using the Clopper Pearson method.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).'}, {'type': 'SECONDARY', 'title': 'Median DoR During Retreatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - COMBO', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG001', 'title': 'TNBC - COMBO', 'description': 'Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG002', 'title': 'PDAC - COMBO', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG003', 'title': 'UBC- MEDI', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'OG004', 'title': 'PDAC - MEDI', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'No DoR data were available for this cohort.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No DoR data were available for this cohort.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No DoR data were available for this cohort.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.3', 'groupId': 'OG003', 'lowerLimit': '7.3', 'upperLimit': '7.3'}, {'value': 'NA', 'comment': 'DoR was not estimable in this cohort', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to 12 months in retreatment phase', 'description': 'DoR during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).'}, {'type': 'SECONDARY', 'title': 'DCR During Retreatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - COMBO', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG001', 'title': 'TNBC - COMBO', 'description': 'Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG002', 'title': 'PDAC - COMBO', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG003', 'title': 'UBC- MEDI', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'OG004', 'title': 'PDAC - MEDI', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '3.67', 'upperLimit': '70.96'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '0.51', 'upperLimit': '71.64'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '0.63', 'upperLimit': '80.59'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.63', 'upperLimit': '80.59'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '97.50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 4 months in retreatment phase', 'description': 'DCR during the retreatment phase was defined as the percentage of patients who had a BoR of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) or who had demonstrated SD for a minimum interval of 3 or 4 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).'}, {'type': 'SECONDARY', 'title': 'Median PFS During Retreatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - COMBO', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG001', 'title': 'TNBC - COMBO', 'description': 'Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG002', 'title': 'PDAC - COMBO', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG003', 'title': 'UBC- MEDI', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'OG004', 'title': 'PDAC - MEDI', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '3.65'}, {'value': '0.99', 'comment': 'Upper limit was not estimable in this cohort.', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': 'NA'}, {'value': '2.86', 'groupId': 'OG002', 'lowerLimit': '1.87', 'upperLimit': '3.52'}, {'value': '2.86', 'groupId': 'OG003', 'lowerLimit': '1.81', 'upperLimit': '6.62'}, {'value': '1.84', 'groupId': 'OG004', 'lowerLimit': '1.84', 'upperLimit': '1.84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to 12 months in retreatment phase', 'description': 'PFS during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression.\n\nProgression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).'}, {'type': 'SECONDARY', 'title': 'BoR During Retreatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - COMBO', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG001', 'title': 'TNBC - COMBO', 'description': 'Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG002', 'title': 'PDAC - COMBO', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG003', 'title': 'UBC- MEDI', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'OG004', 'title': 'PDAC - MEDI', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}]}]}, {'title': 'NE', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 12 months in retreatment phase', 'description': 'BoR during the retreatment phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or NE) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).'}, {'type': 'SECONDARY', 'title': 'Median OS During Retreatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'UBC - COMBO', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG001', 'title': 'TNBC - COMBO', 'description': 'Eligible TNBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG002', 'title': 'PDAC - COMBO', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months.'}, {'id': 'OG003', 'title': 'UBC- MEDI', 'description': 'Eligible UBC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'OG004', 'title': 'PDAC - MEDI', 'description': 'Eligible PDAC patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were sequenced to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.86', 'comment': 'Median and upper limit was not estimable in this cohort.', 'groupId': 'OG000', 'lowerLimit': '5.91', 'upperLimit': 'NA'}, {'value': '33.05', 'groupId': 'OG001', 'lowerLimit': '9.69', 'upperLimit': '33.05'}, {'value': '7.18', 'groupId': 'OG002', 'lowerLimit': '3.98', 'upperLimit': '18.76'}, {'value': '16.53', 'groupId': 'OG003', 'lowerLimit': '7.56', 'upperLimit': '32.39'}, {'value': '4.14', 'comment': 'Lower and upper limits were not estimable in this cohort.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline in retreatment phase to final data cut-off date', 'description': 'OS during the retreatment phase was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'UBC Cohort', 'description': 'Patients with UBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via intravenous (IV) infusion at a dose of 750 milligrams (mg) once every 4 weeks (q4w) for 7 doses (cycles), then every 12 weeks (q12w) for 2 additional cycles, for up to a total of 12 months or until confirmed progressive disease (PD).\n\nEligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive MEDI4736 (durvalumab) + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'FG001', 'title': 'TNBC Cohort', 'description': 'Patients with TNBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.\n\nEligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'FG002', 'title': 'PDAC Cohort', 'description': 'Patients with PDAC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.\n\nEligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Started Retreatment Phase (COMBO)', 'comment': 'COMBO Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Started Retreatment Phase (MEDI)', 'comment': 'MEDI Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 64 patients with select advanced solid tumors were treated in this phase II, open-label, multi-center study from November 2015. Primary data cut off date: 17 February 2018. Final data cut off date: 31 December 2018.', 'preAssignmentDetails': 'The patients were split into 3 different analysis cohorts based on their tumor types: urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC) and pancreatic ductal adenocarcinoma (PDAC).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'UBC Cohort', 'description': 'Patients with UBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.\n\nEligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'BG001', 'title': 'TNBC Cohort', 'description': 'Patients with TNBC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.\n\nEligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'BG002', 'title': 'PDAC Cohort', 'description': 'Patients with PDAC entered the initial tremelimumab monotherapy phase and were administered tremelimumab via IV infusion at a dose of 750 mg q4w for 7 cycles, then q12w for 2 additional cycles, for up to a total of 12 months or until confirmed PD.\n\nEligible patients with confirmed PD on tremelimumab monotherapy or during the follow-up period were given the option for retreatment with tremelimumab monotherapy or to be sequenced to receive durvalumab + tremelimumab combination therapy (also referred to as COMBO; durvalumab 1.5 g via IV infusion q4w in combination with tremelimumab 75 mg via IV infusion q4w for up to 4 cycles each, followed by durvalumab 1.5 g via IV infusion q4w) for up to a total of 8 months or to receive durvalumab monotherapy (also referred to as MEDI; 1.5 g via IV infusion q4w) for up to a total of 12 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-13', 'size': 2053705, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-13T07:44', 'hasProtocol': True}, {'date': '2018-06-22', 'size': 2307780, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-13T07:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2015-08-12', 'resultsFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-13', 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase', 'timeFrame': 'From baseline to 12 months in the tremelimumab monotherapy phase', 'description': 'Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.'}], 'secondaryOutcomes': [{'measure': 'Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase', 'timeFrame': 'From baseline to 12 months in the tremelimumab monotherapy phase', 'description': 'DoR during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the progression-free survival (PFS) censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.'}, {'measure': 'Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase', 'timeFrame': 'From baseline to 12 months in the tremelimumab monotherapy phase', 'description': 'DCR during the initial tremelimumab monotherapy phase was defined as the percentage of patients who had a best objective response (BoR) of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) and 12 months (all patients), or who had demonstrated stable disease (SD) for a minimum interval of 3, 4 or 12 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.'}, {'measure': 'Median PFS During Tremelimumab Monotherapy Phase', 'timeFrame': 'From baseline to 12 months in the tremelimumab monotherapy phase', 'description': 'PFS during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression. Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.'}, {'measure': 'Best Objective Response (BoR) During Tremelimumab Monotherapy Phase', 'timeFrame': 'From baseline to 12 months in the tremelimumab monotherapy phase', 'description': 'BoR during the initial tremelimumab monotherapy phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or not evaluable \\[NE\\]) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).'}, {'measure': 'Median Overall Survival (OS) During Tremelimumab Monotherapy Phase', 'timeFrame': 'From baseline to final data cut-off date', 'description': 'OS was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. OS is presented from start of tremelimumab monotherapy phase and includes the retreatment phase if the patient entered the corresponding treatment phase.\n\nMedian OS was calculated using the Kaplan-Meier technique.'}, {'measure': 'Percentage of Patients With Confirmed Overall Response During Retreatment Phase', 'timeFrame': 'From baseline to 12 months in retreatment phase', 'description': 'ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR and was based on all treated patients who had measurable disease at baseline (Day 1) and who sequenced to durvalumab monotherapy (MEDI treatment phase) or durvalumab + tremelimumab combination therapy (COMBO treatment phase). 95% CIs were calculated using the Clopper Pearson method.'}, {'measure': 'Median DoR During Retreatment Phase', 'timeFrame': 'From baseline to 12 months in retreatment phase', 'description': 'DoR during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.'}, {'measure': 'DCR During Retreatment Phase', 'timeFrame': 'From baseline to 4 months in retreatment phase', 'description': 'DCR during the retreatment phase was defined as the percentage of patients who had a BoR of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) or who had demonstrated SD for a minimum interval of 3 or 4 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.'}, {'measure': 'Median PFS During Retreatment Phase', 'timeFrame': 'From baseline to 12 months in retreatment phase', 'description': 'PFS during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression.\n\nProgression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.'}, {'measure': 'BoR During Retreatment Phase', 'timeFrame': 'From baseline to 12 months in retreatment phase', 'description': 'BoR during the retreatment phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or NE) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).'}, {'measure': 'Median OS During Retreatment Phase', 'timeFrame': 'From baseline in retreatment phase to final data cut-off date', 'description': 'OS during the retreatment phase was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urothelial bladder cancer, Triple-negative breast cancer, Pancreatic ductal adenocarcinoma, Advanced Solid Tumors, Tremelimumab, MEDI4736, ORR'], 'conditions': ['Urothelial Bladder Cancer', 'Triple-negative Breast Cancer', 'Pancreatic Ductal Adenocarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3801&filename=D4884C00001-statistical-analysis-plan-edition-2_%2022Jun2018_Published%20on%20CARA-redact.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3801&filename=D4884C00001-csp-v4_final_clean_13Sep2018-redact.pdf', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D4884C00001&amp;attachmentIdentifier=e176d601-e473-4d9e-b20b-051d9448cee1&amp;fileName=d4884c00001-study-synopsis_Redacted.pdf&amp;versionIdentifier=', 'label': 'Redacted CSR synopsis'}]}, 'descriptionModule': {'briefSummary': 'A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors', 'detailedDescription': 'This is an open-label, multi-center study to determine the efficacy and safety of tremelimumab in the treatment of different cohorts of patients with selected advanced solid tumors. If eligible and at the discretion of the Investigator, after confirmed disease progression on tremelimumab monotherapy or during follow-up, patients will have the option of being sequenced to MEDI4736 (MedImmune 4736) monotherapy or MEDI4736 + tremelimumab combination therapy, for up to 12 months or until disease progression, whichever comes sooner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '150 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for accurate repeated measurements.\n\nExclusion criteria:\n\n1\\. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient"}, 'identificationModule': {'nctId': 'NCT02527434', 'briefTitle': 'Study of Tremelimumab in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'D4884C00001'}, 'secondaryIdInfos': [{'id': '2015-002934-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treme mono to be sequenced to MEDI4736 mono or combination', 'description': 'tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD)', 'interventionNames': ['Biological: Tremelimumab monotherapy', 'Biological: MEDI4736 monotherapy', 'Biological: MEDI4736 + tremelimumab combination therapy']}], 'interventions': [{'name': 'Tremelimumab monotherapy', 'type': 'BIOLOGICAL', 'description': 'IV infusion', 'armGroupLabels': ['treme mono to be sequenced to MEDI4736 mono or combination']}, {'name': 'MEDI4736 monotherapy', 'type': 'BIOLOGICAL', 'description': 'IV infusion', 'armGroupLabels': ['treme mono to be sequenced to MEDI4736 mono or combination']}, {'name': 'MEDI4736 + tremelimumab combination therapy', 'type': 'BIOLOGICAL', 'description': 'IV infusion', 'armGroupLabels': ['treme mono to be sequenced to MEDI4736 mono or combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '80-214', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '93-513', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '35015', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sharma Padmanee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anderson Cancer Center, the University of Texas'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. 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