Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-24 @ 10:35 PM
Study NCT ID:
NCT02734004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2016-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531550', 'term': 'olaparib'}, {'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.', 'description': 'The safety analysis set included all participants who received at least 1 dose of study treatment.\n\nFor initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.', 'eventGroups': [{'id': 'EG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'deathsNumAffected': 36, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 34, 'seriousNumAtRisk': 34, 'deathsNumAffected': 24, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 32, 'seriousNumAtRisk': 34, 'deathsNumAffected': 26, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'deathsNumAffected': 35, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 50, 'seriousNumAtRisk': 51, 'deathsNumAffected': 13, 'seriousNumAffected': 13}, {'id': 'EG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 31, 'seriousNumAtRisk': 31, 'deathsNumAffected': 17, 'seriousNumAffected': 6}, {'id': 'EG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 32, 'seriousNumAtRisk': 32, 'deathsNumAffected': 20, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 33, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 28, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 55, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 39, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 41, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 20, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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[{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}, {'value': '81.3', 'groupId': 'OG002'}, {'value': '25.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.', 'description': 'The DCR at 12 weeks was defined as the percentage of participants who had complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks. Participants demonstrated SD for a minimum interval of 11 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 77 days) following the start of treatment. The DCR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}, {'type': 'PRIMARY', 'title': 'Second Stage Cohort: Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000', 'lowerLimit': '81.12', 'upperLimit': '97.82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.', 'description': 'The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% confidence interval (CI) were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}, {'type': 'PRIMARY', 'title': 'Second Stage Cohorts: DCR at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000'}, {'value': '28.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.', 'description': 'The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}, {'type': 'SECONDARY', 'title': 'Second Stage Expansion Cohort: DCR at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.', 'description': 'The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}, {'type': 'SECONDARY', 'title': 'Initial Stage Cohorts: DCR at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '65.6', 'groupId': 'OG002'}, {'value': '7.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.', 'description': 'The DCR at 28 weeks was defined as the percentage of participants who had CR + PR + SD at 28 weeks. Participants demonstrated SD for a minimum interval of 27 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 189 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}, {'type': 'SECONDARY', 'title': 'Second Stage Cohorts: DCR at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000'}, {'value': '38.7', 'groupId': 'OG001'}, {'value': '9.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.', 'description': 'The DCR at 56 weeks was defined as the percentage of participants who had CR + PR + SD at 56 weeks. Participants demonstrated SD for a minimum interval of 55 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 385 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}, {'type': 'SECONDARY', 'title': 'Initial and Second Stage Cohorts: ORR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '2.94', 'upperLimit': '24.80'}, {'value': '63.3', 'groupId': 'OG001', 'lowerLimit': '43.86', 'upperLimit': '80.07'}, {'value': '71.9', 'groupId': 'OG002', 'lowerLimit': '53.25', 'upperLimit': '86.25'}, {'value': '10.3', 'groupId': 'OG003', 'lowerLimit': '2.87', 'upperLimit': '24.22'}, {'value': '87.1', 'groupId': 'OG004', 'lowerLimit': '70.17', 'upperLimit': '96.37'}, {'value': '34.4', 'groupId': 'OG005', 'lowerLimit': '18.57', 'upperLimit': '53.19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% CI were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}, {'type': 'SECONDARY', 'title': 'Initial and Second Stage Cohorts: Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '4.6'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '20.3'}, {'value': '10.2', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '22.3'}, {'value': '14.8', 'comment': 'Upper limit of Inter-quartile range was not reached.', 'groupId': 'OG003', 'lowerLimit': '6.4', 'upperLimit': 'NA'}, {'value': '14.8', 'comment': 'Upper limit of Inter-quartile range was not reached.', 'groupId': 'OG004', 'lowerLimit': '9.0', 'upperLimit': 'NA'}, {'value': '11.1', 'groupId': 'OG005', 'lowerLimit': '7.4', 'upperLimit': '22.1'}, {'value': '6.9', 'groupId': 'OG006', 'lowerLimit': '5.4', 'upperLimit': '11.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'The DoR (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. The DoR was calculated using Kaplan-Meier technique.', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with objective response were analyzed.'}, {'type': 'SECONDARY', 'title': 'Initial and Second Stage Cohorts: Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '3.0'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '11.8'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '15.9'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '2.8'}, {'value': '15.0', 'groupId': 'OG004', 'lowerLimit': '12.9', 'upperLimit': '24.1'}, {'value': '14.7', 'groupId': 'OG005', 'lowerLimit': '9.2', 'upperLimit': '18.1'}, {'value': '5.5', 'groupId': 'OG006', 'lowerLimit': '3.6', 'upperLimit': '7.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'The PFS (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until the date of objective PD or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to disease progression. The PFS was calculated using Kaplan-Meier technique.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}, {'type': 'SECONDARY', 'title': 'Initial Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 12 and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.23', 'spread': '54.752', 'groupId': 'OG000'}, {'value': '-26.13', 'spread': '43.033', 'groupId': 'OG001'}, {'value': '-35.86', 'spread': '29.791', 'groupId': 'OG002'}, {'value': '20.81', 'spread': '75.944', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.05', 'spread': '15.671', 'groupId': 'OG000'}, {'value': '-40.85', 'spread': '39.541', 'groupId': 'OG001'}, {'value': '-53.74', 'spread': '31.147', 'groupId': 'OG002'}, {'value': '-41.00', 'spread': '43.625', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 12 and 28. Assessed until DCO 14 Jun 2019', 'description': 'The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment.', 'unitOfMeasure': 'percentage change in tumor size', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with either a tumor size recorded at 12 and 28 weeks or enough information to impute a value were analyzed.'}, {'type': 'SECONDARY', 'title': 'Second Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 24 and 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-66.30', 'spread': '26.672', 'groupId': 'OG000'}, {'value': '-43.00', 'spread': '32.432', 'groupId': 'OG001'}, {'value': '-35.63', 'spread': '34.001', 'groupId': 'OG002'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-77.74', 'spread': '26.472', 'groupId': 'OG000'}, {'value': '-60.00', 'spread': '29.058', 'groupId': 'OG001'}, {'value': '-39.54', 'spread': '33.719', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 24 and 56. Assessed until DCO 17 Sep 2021', 'description': 'The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last assessment prior to Cycle 1 Day 1.', 'unitOfMeasure': 'percentage change in tumor size', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with either a tumor size recorded at 24 and 56 weeks or enough information to impute a value were analyzed.'}, {'type': 'SECONDARY', 'title': 'Initial and Second Stage Cohorts: Best Percentage Change From Baseline in Target Tumor Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.27', 'spread': '32.398', 'groupId': 'OG000'}, {'value': '-47.60', 'spread': '36.823', 'groupId': 'OG001'}, {'value': '-55.55', 'spread': '35.789', 'groupId': 'OG002'}, {'value': '1.64', 'spread': '42.338', 'groupId': 'OG003'}, {'value': '-72.78', 'spread': '31.497', 'groupId': 'OG004'}, {'value': '-53.30', 'spread': '33.317', 'groupId': 'OG005'}, {'value': '-20.42', 'spread': '41.160', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline (Day 1) until confirmed PD/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'The best percentage change from baseline in target tumor size was based on RECIST 1.1 target lesion measurements taken at each RECIST 1.1 assessment. All measurements until PD or the last evaluable assessment in the absence of PD was included in the calculation. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment for initial stage cohorts. Baseline was defined as the last assessment prior to Cycle 1 Day 1 for second stage cohorts.', 'unitOfMeasure': 'percentage change in tumor size', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with at least 1 post baseline RECIST target lesion assessment scan were analyzed.'}, {'type': 'SECONDARY', 'title': 'Initial and Second Stage Cohorts: Time to Study Treatment Discontinuation or Death (TDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.8'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '12.1'}, {'value': '13.1', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '15.9'}, {'value': '2.8', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '3.2'}, {'value': '19.3', 'groupId': 'OG004', 'lowerLimit': '14.7', 'upperLimit': '26.2'}, {'value': '15.9', 'groupId': 'OG005', 'lowerLimit': '10.3', 'upperLimit': '18.4'}, {'value': '6.6', 'groupId': 'OG006', 'lowerLimit': '4.4', 'upperLimit': '8.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline (Day 1) until treatment discontinuation/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'The TDT was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) to the earlier of the date of study treatment discontinuation or death. The TDT was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}, {'type': 'SECONDARY', 'title': 'Initial and Second Stage Cohorts: OS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '8.8'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '16.2', 'upperLimit': '25.5'}, {'value': '35.5', 'groupId': 'OG002', 'lowerLimit': '27.2', 'upperLimit': '50.7'}, {'value': '6.4', 'groupId': 'OG003', 'lowerLimit': '4.3', 'upperLimit': '9.1'}, {'value': 'NA', 'comment': 'Median and 95% CI had not reached.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '31.9', 'comment': 'Upper limit of 95% CI had not reached.', 'groupId': 'OG005', 'lowerLimit': '22.1', 'upperLimit': 'NA'}, {'value': '26.1', 'comment': 'Upper limit of 95% CI had not reached.', 'groupId': 'OG006', 'lowerLimit': '18.7', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline (Day 1) until death from any cause. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts', 'description': 'The OS was defined as the time from the start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until death due to any cause. The OS was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}, {'type': 'SECONDARY', 'title': 'Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'title': 'Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below the lower limit of quantification (LLOQ). The LLOQ of MEDI4736 is 0.05 mcg/mL.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.', 'groupId': 'OG006'}]}]}, {'title': 'Day 1: End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '483.5', 'spread': '35.09', 'groupId': 'OG000'}, {'value': '542.5', 'spread': '36.04', 'groupId': 'OG001'}, {'value': '417.9', 'spread': '33.48', 'groupId': 'OG002'}, {'value': '391.8', 'spread': '25.09', 'groupId': 'OG003'}, {'value': '409.3', 'spread': '33.27', 'groupId': 'OG004'}, {'value': '498.8', 'spread': '30.27', 'groupId': 'OG005'}, {'value': '397.1', 'spread': '18.53', 'groupId': 'OG006'}]}]}, {'title': 'Day 29: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '93.56', 'spread': '54.83', 'groupId': 'OG004'}, {'value': '96.50', 'spread': '34.67', 'groupId': 'OG005'}, {'value': '78.23', 'spread': '56.60', 'groupId': 'OG006'}]}]}, {'title': 'Day 57: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '144.7', 'spread': '38.96', 'groupId': 'OG000'}, {'value': '165.2', 'spread': '40.31', 'groupId': 'OG001'}, {'value': '171.3', 'spread': '31.73', 'groupId': 'OG002'}, {'value': '114.7', 'spread': '44.78', 'groupId': 'OG003'}]}]}, {'title': 'Day 85: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '152.8', 'spread': '50.14', 'groupId': 'OG004'}, {'value': '145.2', 'spread': '55.71', 'groupId': 'OG005'}, {'value': '142.8', 'spread': '63.07', 'groupId': 'OG006'}]}]}, {'title': 'Day 85: End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '610.6', 'spread': '39.64', 'groupId': 'OG004'}, {'value': '589.3', 'spread': '35.48', 'groupId': 'OG005'}, {'value': '482.9', 'spread': '44.01', 'groupId': 'OG006'}]}]}, {'title': 'Day 113: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '119.5', 'spread': '44.27', 'groupId': 'OG000'}, {'value': '220.7', 'spread': '35.97', 'groupId': 'OG001'}, {'value': '231.3', 'spread': '33.45', 'groupId': 'OG002'}, {'value': '196.9', 'spread': '74.60', 'groupId': 'OG003'}]}]}, {'title': 'Day 113: End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '504.8', 'spread': '25.24', 'groupId': 'OG000'}, {'value': '671.5', 'spread': '31.79', 'groupId': 'OG001'}, {'value': '585.5', 'spread': '52.67', 'groupId': 'OG002'}, {'value': '679.1', 'spread': '34.80', 'groupId': 'OG003'}]}]}, {'title': 'Day 169: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '133.1', 'spread': '30.74', 'groupId': 'OG000'}, {'value': '231.5', 'spread': '41.14', 'groupId': 'OG001'}, {'value': '261.6', 'spread': '45.92', 'groupId': 'OG002'}, {'value': '230.7', 'spread': '35.81', 'groupId': 'OG003'}, {'value': '206.3', 'spread': '61.24', 'groupId': 'OG004'}, {'value': '162.6', 'spread': '95.86', 'groupId': 'OG005'}, {'value': '186.6', 'spread': '65.36', 'groupId': 'OG006'}]}]}, {'title': '90 days post last dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6.907', 'spread': '297.9', 'groupId': 'OG000'}, {'value': '12.24', 'spread': '4720', 'groupId': 'OG001'}, {'value': '22.35', 'spread': '120.9', 'groupId': 'OG002'}, {'value': '17.23', 'spread': '155.2', 'groupId': 'OG003'}, {'value': '17.94', 'spread': '331.8', 'groupId': 'OG004'}, {'value': '17.47', 'spread': '78.93', 'groupId': 'OG005'}, {'value': '20.50', 'spread': '340.0', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and within 10 minutes of end of infusion on Days 1, 85 and 113; Pre-dose on Days 29, 57 and 169; and 90 days post last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'Blood samples were collected to determine the serum concentration of MEDI4736.', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The MEDI4736 pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of MEDI4736 and provided evaluable MEDI4736 PK profile for at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Initial and Second Stage Cohorts: Serum Concentrations of Olaparib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'title': 'Monotherapy - Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.', 'groupId': 'OG003'}]}]}, {'title': 'Monotherapy - Day 1: 0.5-1 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3.647', 'spread': '394.2', 'groupId': 'OG000'}, {'value': '2.093', 'spread': '1217', 'groupId': 'OG001'}, {'value': '5.016', 'spread': '150.1', 'groupId': 'OG002'}, {'value': '2.321', 'spread': '291.7', 'groupId': 'OG003'}]}]}, {'title': 'Monotherapy - Day 22: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.374', 'spread': '814.4', 'groupId': 'OG000'}, {'value': '0.8500', 'spread': '1501', 'groupId': 'OG001'}, {'value': '1.242', 'spread': '534.6', 'groupId': 'OG002'}, {'value': '2.053', 'spread': '124.6', 'groupId': 'OG003'}]}]}, {'title': 'Monotherapy - Day 22: 0.5-1 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '7.212', 'spread': '55.84', 'groupId': 'OG000'}, {'value': '5.370', 'spread': '100.9', 'groupId': 'OG001'}, {'value': '6.130', 'spread': '144.9', 'groupId': 'OG002'}, {'value': '5.350', 'spread': '75.21', 'groupId': 'OG003'}]}]}, {'title': 'Combination therapy - Day 15: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.848', 'spread': '172.3', 'groupId': 'OG000'}, {'value': '0.6526', 'spread': '847.8', 'groupId': 'OG001'}, {'value': '1.773', 'spread': '92.68', 'groupId': 'OG002'}, {'value': '1.744', 'spread': '103.7', 'groupId': 'OG003'}, {'value': '1.544', 'spread': '102.3', 'groupId': 'OG004'}, {'value': '1.400', 'spread': '423.2', 'groupId': 'OG005'}, {'value': '0.9718', 'spread': '663.6', 'groupId': 'OG006'}]}]}, {'title': 'Combination therapy - Day 15: 0.5-1 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '5.008', 'spread': '74.54', 'groupId': 'OG000'}, {'value': '2.805', 'spread': '234.2', 'groupId': 'OG001'}, {'value': '4.288', 'spread': '136.4', 'groupId': 'OG002'}, {'value': '3.226', 'spread': '60.08', 'groupId': 'OG003'}, {'value': '5.439', 'spread': '70.73', 'groupId': 'OG004'}, {'value': '5.922', 'spread': '98.89', 'groupId': 'OG005'}, {'value': '6.549', 'spread': '72.47', 'groupId': 'OG006'}]}]}, {'title': 'Combination therapy - Day 15: 1-3 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '8.038', 'spread': '38.24', 'groupId': 'OG000'}, {'value': '4.018', 'spread': '155.6', 'groupId': 'OG001'}, {'value': '5.897', 'spread': '90.04', 'groupId': 'OG002'}, {'value': '4.804', 'spread': '57.38', 'groupId': 'OG003'}, {'value': '7.644', 'spread': '55.09', 'groupId': 'OG005'}]}]}, {'title': 'Combination therapy - Day 15: 3-6 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '7.811', 'spread': '38.68', 'groupId': 'OG000'}, {'value': '5.217', 'spread': '51.57', 'groupId': 'OG001'}, {'value': '6.322', 'spread': '43.84', 'groupId': 'OG002'}, {'value': '5.491', 'spread': '35.36', 'groupId': 'OG003'}, {'value': '5.717', 'spread': '57.30', 'groupId': 'OG005'}]}]}, {'title': 'Combination therapy - Day 15: 6-12 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '5.186', 'spread': '49.67', 'groupId': 'OG000'}, {'value': '2.820', 'spread': '60.56', 'groupId': 'OG001'}, {'value': '3.661', 'spread': '57.35', 'groupId': 'OG002'}, {'value': '3.679', 'spread': '52.80', 'groupId': 'OG003'}, {'value': '3.023', 'spread': '74.63', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.5-1 hour postdose on Days 1 and 22 of monotherapy; Pre-dose and 0.5-1, 1-3, 3-6 and 6-12 hours postdose on Day 15 of combination therapy. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'Blood samples were collected to determine the serum concentration of olaparib.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The olaparib PK analysis set included all participants who received at least 1 dose of olaparib and provided evaluable olaparib PK profile for at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Second Stage Cohort: Serum Concentrations of Bevacizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'title': 'Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ of bevacizumab is 0.5 mcg/mL.', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '243.7', 'spread': '30.01', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '104.6', 'spread': '29.30', 'groupId': 'OG000'}]}]}, {'title': 'Day 85: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '145.5', 'spread': '28.26', 'groupId': 'OG000'}]}]}, {'title': 'Day 85: End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '364.0', 'spread': '23.74', 'groupId': 'OG000'}]}]}, {'title': 'Day 169: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '147.9', 'spread': '118.0', 'groupId': 'OG000'}]}]}, {'title': '90 days post last dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.094', 'spread': '224.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and within 10 minutes of end of infusion on Days 1 and 85; Pre-dose on Days 29 and 169; and 90 days post last dose of bevacizumab. Assessed until DCO 17 Sep 2021', 'description': 'Blood samples were collected to determine the serum concentration of bevacizumab.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The bevacizumab PK analysis set included all participants who received at least 1 dose of bevacizumab and provided any post-dose evaluable bevacizumab PK concentration.'}, {'type': 'SECONDARY', 'title': 'Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'OG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'classes': [{'title': 'ADA prevalence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'ADA incidence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'ADA positive post-baseline and positive at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'ADA positive post-baseline and not detected at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'ADA not detected post-baseline and positive at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Persistent positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Transient positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Any nAb positive among any ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-dose on Days 1, 15, 57, 85, 113 and 169; and 90 days post-last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for MEDI4736 using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Treatment-boosted ADA was defined as baseline ADA titer that was boosted to 4-fold or higher following drug administration. Persistently positive was defined as positive at \\>=2 post-baseline assessments (with \\>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADA analysis set included all participants in the safety analysis set who have non-missing baseline ADA and at least 1 non-missing post-baseline ADA result for MEDI4736.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 milligram (mg) orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 grams (g) intravenous (IV) infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'FG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'FG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'FG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'FG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'FG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kilogram (kg) IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'FG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '51'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '51'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '34'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'This Phase I/II open-label study was conducted in participants with advanced solid tumors at 43 centers in France, the United Kingdom, the Republic of Korea, the USA, the Netherlands, Israel, and Switzerland. Initial stage cohorts: Results are reported for analysis with assessment until data cut-off (DCO) of 14 Jun 2019 \\[except for overall survival (OS) for ovarian cancer cohort (DCO: 17 Sep 2021)\\]. Second stage cohorts: Results are reported for analysis with assessment until DCO of 17 Sep 2021.', 'preAssignmentDetails': 'This study consists a screening period (28 days), run-in monotherapy treatment period (initial stage cohort only; 4 weeks) followed by combination therapy treatment period until progressive disease (PD). 148 participants entered initial stage cohorts and 114 participants entered second stage cohorts. Thus, 262 participants were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '253', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Initial Stage: Small Cell Lung Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'BG001', 'title': 'Initial Stage: Breast Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'BG002', 'title': 'Initial Stage: Ovarian Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'BG003', 'title': 'Initial Stage: Gastric Cancer', 'description': 'Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'BG004', 'title': 'Second Stage: Ovarian Cancer Expansion', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'BG005', 'title': 'Second Stage: Ovarian Cancer Triplet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'BG006', 'title': 'Second Stage: Ovarian Cancer Doublet', 'description': 'Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.'}, {'id': 'BG007', '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'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '175', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '78', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '205', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '48', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '162', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '57', 'groupId': 'BG007'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Missing', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '32', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}, {'value': '220', 'groupId': 'BG007'}]}, {'title': 'Missing', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '32', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-17', 'size': 2598985, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-14T03:36', 'hasProtocol': True}, {'date': '2019-07-18', 'size': 1525907, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-14T03:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03079687', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2016-03-17', 'resultsFirstSubmitDate': '2022-09-14', 'studyFirstSubmitQcDate': '2016-04-06', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-10-12', 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12', 'timeFrame': 'RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.', 'description': 'The DCR at 12 weeks was defined as the percentage of participants who had complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks. Participants demonstrated SD for a minimum interval of 11 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 77 days) following the start of treatment. The DCR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).'}, {'measure': 'Second Stage Cohort: Objective Response Rate (ORR)', 'timeFrame': 'RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.', 'description': 'The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% confidence interval (CI) were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.'}, {'measure': 'Second Stage Cohorts: DCR at Week 24', 'timeFrame': 'RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.', 'description': 'The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.'}], 'secondaryOutcomes': [{'measure': 'Second Stage Expansion Cohort: DCR at Week 24', 'timeFrame': 'RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.', 'description': 'The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.'}, {'measure': 'Initial Stage Cohorts: DCR at Week 28', 'timeFrame': 'RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.', 'description': 'The DCR at 28 weeks was defined as the percentage of participants who had CR + PR + SD at 28 weeks. Participants demonstrated SD for a minimum interval of 27 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 189 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.'}, {'measure': 'Second Stage Cohorts: DCR at Week 56', 'timeFrame': 'RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.', 'description': 'The DCR at 56 weeks was defined as the percentage of participants who had CR + PR + SD at 56 weeks. Participants demonstrated SD for a minimum interval of 55 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 385 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.'}, {'measure': 'Initial and Second Stage Cohorts: ORR', 'timeFrame': 'RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% CI were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.'}, {'measure': 'Initial and Second Stage Cohorts: Duration of Response (DoR)', 'timeFrame': 'RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'The DoR (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. The DoR was calculated using Kaplan-Meier technique.'}, {'measure': 'Initial and Second Stage Cohorts: Progression-Free Survival (PFS)', 'timeFrame': 'RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'The PFS (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until the date of objective PD or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to disease progression. The PFS was calculated using Kaplan-Meier technique.'}, {'measure': 'Initial Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 12 and 28', 'timeFrame': 'Baseline (Day 1) and Weeks 12 and 28. Assessed until DCO 14 Jun 2019', 'description': 'The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment.'}, {'measure': 'Second Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 24 and 56', 'timeFrame': 'Baseline (Day 1) and Weeks 24 and 56. Assessed until DCO 17 Sep 2021', 'description': 'The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last assessment prior to Cycle 1 Day 1.'}, {'measure': 'Initial and Second Stage Cohorts: Best Percentage Change From Baseline in Target Tumor Size', 'timeFrame': 'From baseline (Day 1) until confirmed PD/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'The best percentage change from baseline in target tumor size was based on RECIST 1.1 target lesion measurements taken at each RECIST 1.1 assessment. All measurements until PD or the last evaluable assessment in the absence of PD was included in the calculation. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment for initial stage cohorts. Baseline was defined as the last assessment prior to Cycle 1 Day 1 for second stage cohorts.'}, {'measure': 'Initial and Second Stage Cohorts: Time to Study Treatment Discontinuation or Death (TDT)', 'timeFrame': 'From baseline (Day 1) until treatment discontinuation/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'The TDT was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) to the earlier of the date of study treatment discontinuation or death. The TDT was calculated using the Kaplan-Meier technique.'}, {'measure': 'Initial and Second Stage Cohorts: OS', 'timeFrame': 'From baseline (Day 1) until death from any cause. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts', 'description': 'The OS was defined as the time from the start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until death due to any cause. The OS was calculated using the Kaplan-Meier technique.'}, {'measure': 'Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736', 'timeFrame': 'Pre-dose and within 10 minutes of end of infusion on Days 1, 85 and 113; Pre-dose on Days 29, 57 and 169; and 90 days post last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'Blood samples were collected to determine the serum concentration of MEDI4736.'}, {'measure': 'Initial and Second Stage Cohorts: Serum Concentrations of Olaparib', 'timeFrame': 'Pre-dose and 0.5-1 hour postdose on Days 1 and 22 of monotherapy; Pre-dose and 0.5-1, 1-3, 3-6 and 6-12 hours postdose on Day 15 of combination therapy. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'Blood samples were collected to determine the serum concentration of olaparib.'}, {'measure': 'Second Stage Cohort: Serum Concentrations of Bevacizumab', 'timeFrame': 'Pre-dose and within 10 minutes of end of infusion on Days 1 and 85; Pre-dose on Days 29 and 169; and 90 days post last dose of bevacizumab. Assessed until DCO 17 Sep 2021', 'description': 'Blood samples were collected to determine the serum concentration of bevacizumab.'}, {'measure': 'Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736', 'timeFrame': 'Pre-dose on Days 1, 15, 57, 85, 113 and 169; and 90 days post-last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively', 'description': 'Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for MEDI4736 using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Treatment-boosted ADA was defined as baseline ADA titer that was boosted to 4-fold or higher following drug administration. Persistently positive was defined as positive at \\>=2 post-baseline assessments (with \\>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MEDIOLA', 'Olaparib', 'MEDI4736', 'Bevacizumab', 'Ovarian cancer', 'Breast cancer', 'Small Cell Lung Cancer', 'Gastric Cancer', 'Phase I/II, Adults', 'PDL-1'], 'conditions': ['Ovarian', 'Breast', 'SCLC', 'Gastric Cancers']}, 'referencesModule': {'references': [{'pmid': '37939124', 'type': 'DERIVED', 'citation': "Drew Y, Kim JW, Penson RT, O'Malley DM, Parkinson C, Roxburgh P, Plummer R, Im SA, Imbimbo M, Ferguson M, Rosengarten O, Steeghs N, Kim MH, Gal-Yam E, Tsoref D, Kim JH, You B, De Jonge M, Lalisang R, Gort E, Bastian S, Meyer K, Feeney L, Baker N, Ah-See ML, Domchek SM, Banerjee S; MEDIOLA Investigators. Olaparib plus Durvalumab, with or without Bevacizumab, as Treatment in PARP Inhibitor-Naive Platinum-Sensitive Relapsed Ovarian Cancer: A Phase II Multi-Cohort Study. Clin Cancer Res. 2024 Jan 5;30(1):50-62. doi: 10.1158/1078-0432.CCR-23-2249."}, {'pmid': '35756843', 'type': 'DERIVED', 'citation': "Staniszewska AD, Armenia J, King M, Michaloglou C, Reddy A, Singh M, San Martin M, Prickett L, Wilson Z, Proia T, Russell D, Thomas M, Delpuech O, O'Connor MJ, Leo E, Angell H, Valge-Archer V. PARP inhibition is a modulator of anti-tumor immune response in BRCA-deficient tumors. Oncoimmunology. 2022 Jun 18;11(1):2083755. doi: 10.1080/2162402X.2022.2083755. eCollection 2022."}, {'pmid': '32771088', 'type': 'DERIVED', 'citation': 'Domchek SM, Postel-Vinay S, Im SA, Park YH, Delord JP, Italiano A, Alexandre J, You B, Bastian S, Krebs MG, Wang D, Waqar SN, Lanasa M, Rhee J, Gao H, Rocher-Ros V, Jones EV, Gulati S, Coenen-Stass A, Kozarewa I, Lai Z, Angell HK, Opincar L, Herbolsheimer P, Kaufman B. Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study. Lancet Oncol. 2020 Sep;21(9):1155-1164. doi: 10.1016/S1470-2045(20)30324-7. Epub 2020 Aug 6.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081KC00001&attachmentIdentifier=54f68400-a701-4a0d-8cab-0b0cc000d3c4&fileName=D081KC00001_CSP-v7_Redacted.pdf&versionIdentifier=', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081KC00001&attachmentIdentifier=ceade008-aa3e-4dea-8e71-4e0eb7db1cc5&fileName=D081KC00001_CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081KC00001&attachmentIdentifier=d52a57f7-cf47-4fc2-ba93-9357db074c41&fileName=D081KC00001_SAP_Redacted.pdf&versionIdentifier=', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.', 'detailedDescription': 'This is a phase I/II open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK) and antitumor activity of MEDI4736 in combination with olaparib in patients with advanced solid tumors, selected based on a rationale for response to olaparib.\n\nPatients will be poly (adenosine diphosphate-ribose) polymerase (PARP)-inhibitor and immunotherapy (IMT)-naïve (defined as no prior exposure to PARP inhibitors or IMT, including, but not limited to, other anti-cytotoxic T-lymphocyte-associated protein 4 \\[CTLA-4\\], anti-programmed cell death 1 \\[PD-1\\], anti-programmed death-ligand 1 \\[PD-L1\\] monoclonal antibodies, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n\nThe 4 initial stage cohorts (Modules 1 to 4) include patients with relapsed small cell lung cancer (SCLC), germline BRCA mutated (gBRCAm) metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer, gBRCAm platinum-sensitive relapsed ovarian cancer, and gastric cancer. The data cut-off occurred once all 4 Modules had reached last patient first visit (LPFV) + 2 years and all 4 cohorts had observed a median value for PFS.\n\nSecond stage cohorts (Modules 5 to 7) include patients with relapsed gBRCAm platinum-sensitive relapsed ovarian cancer and non gBRCAm platinum-sensitive relapsed ovarian cancer. The final data cut-off will be once Modules 6 and 7 have observed a median value for overall survival. At this timepoint, the clinical study database will close to new data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients must have histologically or cytologically confirmed progressive advanced or metastatic solid tumor of one of the following:\n\n * Platinum sensitive relapsed small cell lung cancer (module 1)\n * gBRCAm HER2-negative metastatic breast cancer (module 2)\n * gBRCAm ovarian cancer (modules 3 and 5)\n * Metastatic or relapsed Gastric cancer (adenocarcinoma) (module 4)\n * gBRCAm negative ovarian cancer (modules 6 and 7)\n* At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (or magnetic resonance imaging \\[MRI\\] suitable for assessment as per RECIST 1.1. The baseline scan must be obtained within 28 days prior to the first dose of olaparib.\n* Male or female patients, age ≥18 years (≥19 years for South Korea)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Life expectancy ≥12 weeks\n* Adequate organ and marrow function\n* Ability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses that would preclude the absorption of olaparib, which is an oral agent. For the gastric cancer cohort, patients with a full or partial gastrectomy will be permitted.\n* Ability of patient to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations.\n* Female patients must either:\n\n * Be of non-reproductive potential OR\n * Have a negative serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1, and agree to use contraception if they or their partner are of reproductive potential\n\nExclusion criteria\n\n* Prior chemotherapy or other systemic anticancer therapy within 4 weeks prior to start of olaparib treatment, 6 weeks for nitrosoureas or mitomycin. Exceptions include: Anti-hormonal treatment for ER positive or PR positive breast cancer is allowed until 7 days prior to treatment with olaparib, exposure to an investigational agent within 30 days or 5 half-lives (whichever is the longer) prior to start of olaparib treatment is not allowed, prior receipt of biologics targeting T cell co-regulatory proteins and/or immune checkpoints is not allowed. Examples include MEDI4736 or other PD1 or PD-L1 or PD-L2 inhibitors or anti-CTLA4 therapy, previous treatment with a PARP inhibitor, is not allowed.\n* Radiation therapy within 4 weeks prior to start of olaparib treatment (includes radiation targeting bone metastases) or radionuclide treatment within 6 weeks of treatment start.\n* Current dependency on total parenteral nutrition or IV fluid hydration.\n* Concomitant use of known strong cytochrome P450 (CYP) 3A (CYP3A) inhibitors or moderate CYP3A inhibitors. Concomitant use of known strong or moderate CYP3A inducers.\n* Concomitant therapy with any other anticancer therapy or chronic use of systemic corticosteroids.\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation\n* Whole blood transfusions in the last 120 days\n* Patients with symptomatic or uncontrolled brain metastases.\n* Patients being considered at poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease.\n* Any psychiatric disorder that prohibits obtaining informed consent\n* Major surgery or significant traumatic injury within 2 weeks of run-in\n* Immunocompromised patients\n* QTc prolongation \\>470 msec or other significant ECG abnormality noted within 14 days of treatment\n* Pregnant and breastfeeding women are excluded.\n* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)\n* Previous enrolment in the present study\n* Participation in a clinical study within 28 days or 5 half-lives of the drug, whichever is longer.'}, 'identificationModule': {'nctId': 'NCT02734004', 'acronym': 'MEDIOLA', 'briefTitle': 'A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'D081KC00001'}, 'secondaryIdInfos': [{'id': '2015-004005-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Includes initial stage cohorts (modules 1 to 4): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 5 day 1', 'interventionNames': ['Drug: Olaparib', 'Drug: MEDI4736']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Includes 2nd stage cohorts (modules 5 \\& 7): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 1 day 1', 'interventionNames': ['Drug: Olaparib', 'Drug: MEDI4736']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Includes 2nd stage cohort (module 6): Olaparib twice daily starting on week 1 day 1 / MEDI4736 every 4 weeks starting on week 1 day 1 / Bevacizumab every 2 weeks starting on week 1 day 1', 'interventionNames': ['Drug: Olaparib', 'Drug: MEDI4736', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Olaparib', 'type': 'DRUG', 'description': 'Olaparib', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}, {'name': 'MEDI4736', 'type': 'DRUG', 'description': 'MEDI4736', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30265', 'city': 'Newnan', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43026', 'city': 'Hilliard', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.0334, 'lon': -83.15825}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 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'city': 'Goyang-si', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '13620', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'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': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06273', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', '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}}, {'zip': 'CH-7000', 'city': 'Chur', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SW3 6JJ', 'city': 'Greater London', 'country': 'United Kingdom', 'facility': 'Research Site'}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 9RY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Susan Domchek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center, University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Iqvia Pty Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}