Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-04-17 @ 5:05 AM
Study NCT ID:
NCT02093351
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531550', 'term': 'olaparib'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialtransparency@astrazeneca.com', 'title': 'Dr Carsten Goessl, Indication Lead', 'organization': 'AstraZeneca Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'At the end of Part B, the continued access phase (CAP) allowed patients to continue to receive olaparib if deriving clinical benefit. No clinical data was databased during the CAP, thus AE data is presented to the end of Part B only.'}}, 'adverseEventsModule': {'timeFrame': 'For Part A, adverse events (AEs) were collected from the date of first dose up to last dose of study medication in Part A for patients continuing to Part B, or up to 30 days after last dose for patients who did not enter Part B (up to approximately 2 months). For Part B, AEs were collected from date of first dose in Part B up to 30 days after last dose (up to approximately 18 months).', 'description': 'AE data is reported as treatment-emergent AEs. Each Part A cohort received treatment over 3 Treatment Periods. There was a washout period of 4 days between Treatment Periods 1 and 2, and no washout period between Treatment Periods 2 and 3. MedDRA v18.1 was used for Part B.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 - Tamoxifen', 'description': 'In Part A, patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 27, 'seriousNumAtRisk': 30, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cohort 2 - Anastrozole', 'description': 'In Part A, patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 20, 'seriousNumAtRisk': 23, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 3 - Letrozole', 'description': 'In Part A, patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 20, 'seriousNumAtRisk': 26, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Olaparib (Part B)', 'description': 'In Part B, patients continued to receive olaparib 300 mg bd either as monotherapy or in combination with routine clinical regimes of letrozole, anastrazole or tamoxifen if deemed necessary by the investigator.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 66, 'seriousNumAtRisk': 69, 'deathsNumAffected': 1, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 27, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 32, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 34, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 36, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Blood Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Peripheral Sensory Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Vaginal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Gamma-glutamyltransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}], 'seriousEvents': [{'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Anaemia Macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Device Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Klebsiella Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Bladder Transitional Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Cancer Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Cognitive Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Superior Vena Cava Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0/18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Olaparib on Exposure to Tamoxifen - Cmax ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Tamoxifen Alone (Treatment Period 2)', 'description': 'Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.'}, {'id': 'OG001', 'title': 'Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)', 'description': 'Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.'}], 'classes': [{'title': 'PK analysis of tamoxifen', 'categories': [{'measurements': [{'value': '130.3', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '154.2', 'spread': '34.9', 'groupId': 'OG001'}]}]}, {'title': 'PK analysis of N-DMT', 'categories': [{'measurements': [{'value': '162.9', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '149.1', 'spread': '44.8', 'groupId': 'OG001'}]}]}, {'title': 'PK analysis of endoxifen', 'categories': [{'measurements': [{'value': '5.923', 'spread': '65.7', 'groupId': 'OG000'}, {'value': '5.727', 'spread': '61.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.13', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.22', 'estimateComment': 'olaparib + tamoxifen vs. tamoxifen', 'groupDescription': 'Analysis of tamoxifen PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% confidence interval (CI) for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31', 'description': 'Tamoxifen, N-desmethyl tamoxifen (N-DMT) and endoxifen Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Tamoxifen on Exposure to Olaparib - Cmax ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Olaparib (Treatment Period 1)', 'description': 'Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.'}, {'id': 'OG001', 'title': 'Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)', 'description': 'Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.456', 'spread': '41.5', 'groupId': 'OG000'}, {'value': '7.216', 'spread': '43.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.80', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.90', 'estimateComment': 'olaparib + tamoxifen vs. olaparib', 'groupDescription': 'Analysis of olaparib PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31', 'description': 'Olaparib Cmax ss in the presence and absence of co-administered tamoxifen, and associated Cmax ss treatment ratios', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Olaparib on Exposure to Anastrozole - Cmax ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2 - Anastrozole Alone (Treatment Period 2)', 'description': 'Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.'}, {'id': 'OG001', 'title': 'Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)', 'description': 'Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.98', 'spread': '36.2', 'groupId': 'OG000'}, {'value': '35.83', 'spread': '31.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares (GLS) Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.90', 'ciLowerLimit': '0.84', 'ciUpperLimit': '0.97', 'estimateComment': 'olaparib + anastrozole vs. anastrozole', 'groupDescription': 'Analysis of anastrozole PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24', 'description': 'Anastrozole maximum plasma concentration at steady state (Cmax ss) in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios', 'unitOfMeasure': 'micrograms per millilitre (mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Anastrozole on Exposure to Olaparib - Cmax ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2 - Olaparib (Treatment Period 1)', 'description': 'Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.'}, {'id': 'OG001', 'title': 'Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)', 'description': 'Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.490', 'spread': '34.3', 'groupId': 'OG000'}, {'value': '8.256', 'spread': '39.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.94', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.04', 'estimateComment': 'olaparib + anastrozole vs. olaparib', 'groupDescription': 'Analysis of olaparib PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24', 'description': 'Olaparib Cmax ss in the presence and absence of co-administered anastrozole, and associated Cmax ss treatment ratios', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Olaparib on Exposure to Letrozole - Cmax ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3 - Letrozole Alone (Treatment Period 2)', 'description': 'Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.'}, {'id': 'OG001', 'title': 'Cohort 3 - Olaparib + Letrozole (Treatment Period 3)', 'description': 'Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.'}], 'classes': [{'categories': [{'measurements': [{'value': '118.9', 'spread': '32.6', 'groupId': 'OG000'}, {'value': '111.8', 'spread': '30.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.94', 'ciLowerLimit': '0.91', 'ciUpperLimit': '0.98', 'estimateComment': 'olaparib + letrozole vs. letrozole', 'groupDescription': 'Analysis of letrozole PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43', 'description': 'Letrozole Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Letrozole on Exposure to Olaparib - Cmax ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3 - Olaparib (Treatment Period 1)', 'description': 'Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.'}, {'id': 'OG001', 'title': 'Cohort 3 - Olaparib + Letrozole (Treatment Period 3)', 'description': 'Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.05', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '10.48', 'spread': '33.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.09', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.21', 'estimateComment': 'olaparib + letrozole vs. olaparib', 'groupDescription': 'Analysis of olaparib PK parameters', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43', 'description': 'Olaparib Cmax ss in the presence and absence of co-administered letrozole, and associated Cmax ss treatment ratios', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Olaparib on Exposure to Tamoxifen - AUC0-τ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Tamoxifen Alone (Treatment Period 2)', 'description': 'Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.'}, {'id': 'OG001', 'title': 'Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)', 'description': 'Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.'}], 'classes': [{'title': 'PK analysis of tamoxifen', 'categories': [{'measurements': [{'value': '2233', 'spread': '31.9', 'groupId': 'OG000'}, {'value': '2751', 'spread': '28.9', 'groupId': 'OG001'}]}]}, {'title': 'PK analysis of N-DMT', 'categories': [{'measurements': [{'value': '3189', 'spread': '28.8', 'groupId': 'OG000'}, {'value': '2955', 'spread': '37.3', 'groupId': 'OG001'}]}]}, {'title': 'PK analysis of endoxifen', 'categories': [{'measurements': [{'value': '119.3', 'spread': '66.1', 'groupId': 'OG000'}, {'value': '115.8', 'spread': '64.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.16', 'ciLowerLimit': '1.11', 'ciUpperLimit': '1.21', 'estimateComment': 'olaparib + tamoxifen vs. tamoxifen', 'groupDescription': 'Analysis of tamoxifen PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31', 'description': 'Tamoxifen, N-DMT and endoxifen AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios', 'unitOfMeasure': 'microgram x hour/millilitre (mcg*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Tamoxifen on Exposure to Olaparib - AUC0-τ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 - Olaparib (Treatment Period 1)', 'description': 'Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.'}, {'id': 'OG001', 'title': 'Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)', 'description': 'Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.12', 'spread': '51.6', 'groupId': 'OG000'}, {'value': '42.27', 'spread': '60.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.73', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.84', 'estimateComment': 'olaparib + tamoxifen vs. olaparib', 'groupDescription': 'Analysis of olaparib PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31', 'description': 'Olaparib AUC0-τ, in the presence and absence of co-administered tamoxifen, and associated AUC0-τ treatment ratios', 'unitOfMeasure': 'mcg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Olaparib on Exposure to Anastrozole - AUC0-τ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2 - Anastrozole Alone (Treatment Period 2)', 'description': 'Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.'}, {'id': 'OG001', 'title': 'Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)', 'description': 'Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '696.8', 'spread': '36.6', 'groupId': 'OG000'}, {'value': '582.5', 'spread': '31.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.86', 'ciLowerLimit': '0.80', 'ciUpperLimit': '0.93', 'estimateComment': 'olaparib + anastrozole vs. anastrozole', 'groupDescription': 'Analysis of anastrozole PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24', 'description': 'Anastrozole Area under plasma concentration-time curve over the dosing interval at steady state (AUC0-τ), in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios', 'unitOfMeasure': 'mcg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Anastrozole on Exposure to Olaparib - AUC0-τ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2 - Olaparib (Treatment Period 1)', 'description': 'Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.'}, {'id': 'OG001', 'title': 'Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)', 'description': 'Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.49', 'spread': '53.8', 'groupId': 'OG000'}, {'value': '44.33', 'spread': '63.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.89', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.05', 'estimateComment': 'olaparib + anastrozole vs. olaparib', 'groupDescription': 'Analysis of olaparib PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24', 'description': 'Olaparib AUC0-τ, in the presence and absence of co-administered anastrozole, and associated AUC0-τ treatment ratios', 'unitOfMeasure': 'mcg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Olaparib on Exposure to Letrozole - AUC0-τ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3 - Letrozole Alone (Treatment Period 2)', 'description': 'Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.'}, {'id': 'OG001', 'title': 'Cohort 3 - Olaparib + Letrozole (Treatment Period 3)', 'description': 'Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.'}], 'classes': [{'categories': [{'measurements': [{'value': '2292', 'spread': '36.7', 'groupId': 'OG000'}, {'value': '2167', 'spread': '38.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.95', 'ciLowerLimit': '0.91', 'ciUpperLimit': '0.99', 'estimateComment': 'olaparib + letrozole vs. letrozole', 'groupDescription': 'Analysis of letrozole PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43', 'description': 'Letrozole AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios', 'unitOfMeasure': 'mcg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}, {'type': 'PRIMARY', 'title': 'Effect of Letrozole on Exposure to Olaparib - AUC0-τ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3 - Olaparib (Treatment Period 1)', 'description': 'Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.'}, {'id': 'OG001', 'title': 'Cohort 3 - Olaparib + Letrozole (Treatment Period 3)', 'description': 'Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.77', 'spread': '43.2', 'groupId': 'OG000'}, {'value': '67.82', 'spread': '44.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GLS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.15', 'ciLowerLimit': '1.07', 'ciUpperLimit': '1.25', 'estimateComment': 'olaparib + letrozole vs. olaparib', 'groupDescription': 'Analysis of olaparib PK parameters.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43', 'description': 'Olaparib AUC0-τ, in the presence and absence of co-administered letrozole, and associated AUC0-τ treatment ratios', 'unitOfMeasure': 'mcg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 - Tamoxifen', 'description': 'In Part A, patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.'}, {'id': 'FG001', 'title': 'Cohort 2 - Anastrozole', 'description': 'In Part A, patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.'}, {'id': 'FG002', 'title': 'Cohort 3 - Letrozole', 'description': 'In Part A, patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.'}, {'id': 'FG003', 'title': 'Olaparib (Part B)', 'description': 'In Part B, patients continued to receive olaparib 300 mg bd either as monotherapy or in combination with routine clinical regimes of letrozole, anastrazole or tamoxifen if deemed necessary by the investigator.'}], 'periods': [{'title': 'Part A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Completing Treatment Period 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Completing Treatment Period 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Completing Treatment Period 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Condition under investigation worsened', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part B', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Only the Olaparib (Part B) arm is applicable for this period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Only the Olaparib (Part B) arm is applicable for this period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Only the Olaparib (Part B) arm is applicable for this period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Eligible patients completing Part A entered Part B for continued access to olaparib.', 'groupId': 'FG003', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Complete response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse event + disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Condition under investigation worsened', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "First patient enrolled: 01 Sep 2014; last completed Part A: 28 Apr 2015. Last patient completed Part B: 27 Apr 2016. Part A assessed olaparib's effect on the pharmacokinetic (PK) parameters of anastrozole, letrozole and tamoxifen and vice versa; in Part B eligible patients received olaparib providing further safety data. Target accrual was met.", 'preAssignmentDetails': '79 patients were assigned to study treatment and received at least 1 dose of olaparib in Part A; 18 patients did not fulfil eligibility criteria. Part A of the study consisted of 3 treatment periods preceded by a screening period. There was a 4-day washout between the first two treatment periods.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1 - Tamoxifen', 'description': 'In Part A, patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.'}, {'id': 'BG001', 'title': 'Cohort 2 - Anastrozole', 'description': 'In Part A, patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.'}, {'id': 'BG002', 'title': 'Cohort 3 - Letrozole', 'description': 'In Part A, patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '11.32', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '11.68', 'groupId': 'BG001'}, {'value': '64.0', 'spread': '7.79', 'groupId': 'BG002'}, {'value': '58.3', 'spread': '11.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All patients enrolled in Part A of the study and who received at least 1 dose of olaparib were included in the baseline analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2014-03-06', 'resultsFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-26', 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Olaparib on Exposure to Tamoxifen - Cmax ss', 'timeFrame': 'Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31', 'description': 'Tamoxifen, N-desmethyl tamoxifen (N-DMT) and endoxifen Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios'}, {'measure': 'Effect of Tamoxifen on Exposure to Olaparib - Cmax ss', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31', 'description': 'Olaparib Cmax ss in the presence and absence of co-administered tamoxifen, and associated Cmax ss treatment ratios'}, {'measure': 'Effect of Olaparib on Exposure to Anastrozole - Cmax ss', 'timeFrame': 'Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24', 'description': 'Anastrozole maximum plasma concentration at steady state (Cmax ss) in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios'}, {'measure': 'Effect of Anastrozole on Exposure to Olaparib - Cmax ss', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24', 'description': 'Olaparib Cmax ss in the presence and absence of co-administered anastrozole, and associated Cmax ss treatment ratios'}, {'measure': 'Effect of Olaparib on Exposure to Letrozole - Cmax ss', 'timeFrame': 'Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43', 'description': 'Letrozole Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios'}, {'measure': 'Effect of Letrozole on Exposure to Olaparib - Cmax ss', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43', 'description': 'Olaparib Cmax ss in the presence and absence of co-administered letrozole, and associated Cmax ss treatment ratios'}, {'measure': 'Effect of Olaparib on Exposure to Tamoxifen - AUC0-τ', 'timeFrame': 'Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31', 'description': 'Tamoxifen, N-DMT and endoxifen AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios'}, {'measure': 'Effect of Tamoxifen on Exposure to Olaparib - AUC0-τ', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31', 'description': 'Olaparib AUC0-τ, in the presence and absence of co-administered tamoxifen, and associated AUC0-τ treatment ratios'}, {'measure': 'Effect of Olaparib on Exposure to Anastrozole - AUC0-τ', 'timeFrame': 'Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24', 'description': 'Anastrozole Area under plasma concentration-time curve over the dosing interval at steady state (AUC0-τ), in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios'}, {'measure': 'Effect of Anastrozole on Exposure to Olaparib - AUC0-τ', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24', 'description': 'Olaparib AUC0-τ, in the presence and absence of co-administered anastrozole, and associated AUC0-τ treatment ratios'}, {'measure': 'Effect of Olaparib on Exposure to Letrozole - AUC0-τ', 'timeFrame': 'Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43', 'description': 'Letrozole AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios'}, {'measure': 'Effect of Letrozole on Exposure to Olaparib - AUC0-τ', 'timeFrame': 'Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43', 'description': 'Olaparib AUC0-τ, in the presence and absence of co-administered letrozole, and associated AUC0-τ treatment ratios'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['oncology, cancer, tumour, neoplasm, anticancer drug, pharmacokinetics, olaparib, anastrozole, tamoxifen, letrozole,'], 'conditions': ['Solid Tumours']}, 'referencesModule': {'references': [{'pmid': '30324586', 'type': 'DERIVED', 'citation': 'Plummer R, Verheul HM, De Vos FYFL, Leunen K, Molife LR, Rolfo C, Grundtvig-Sorensen P, De Greve J, Rottey S, Jerusalem G, Italiano A, Spicer J, Dirix L, Goessl C, Birkett J, Spencer S, Learoyd M, Bailey C, Dean E. Pharmacokinetic Effects and Safety of Olaparib Administered with Endocrine Therapy: A Phase I Study in Patients with Advanced Solid Tumours. Adv Ther. 2018 Nov;35(11):1945-1964. doi: 10.1007/s12325-018-0804-z. Epub 2018 Oct 15.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2882&filename=D081CC00001%20Clinical%20Study%20Protocol_REDACTED%20SECURED.PDF', 'label': 'Clinical Study Protocol REDACTED'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible) continued access to olaparib after the PK phase and will provide additional safety data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of written informed consent prior to any study specific procedures\n2. Male or female aged ≥18 years\n3. Histological or cytological confirmation of any malignant solid tumour in an advanced or metastatic setting who meet one of the criteria below:\n\n * Patients should be resistant or refractory to standard treatment if such treatment exists OR\n * Patients for which no suitable effective standard therapy exists OR\n * Patients with advanced breast cancer for whom anastrozole, letrozole or tamoxifen are indicated may also enter the study (postmenopausal breast cancer patients will be eligible for any of the cohorts; however, premenopausal breast cancer patients will be eligible for the tamoxifen cohort only).\n4. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:\n\n * Haemoglobin (Hb) ≥10.0 g/dL with no blood transfusions in the past 28 days\n * Absolute neutrophil count (ANC) ≥1.5 x 109/L\n * Platelet count ≥100 x 109/L\n * Total bilirubin ≤1.5 x institutional upper limit of normal (ULN) (except in the case of Gilbert's disease)\n * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤2.5 x institutional ULN unless liver metastases are present, in which case they must be ≤5x ULN\n * Serum creatinine ≤1.5 x institutional ULN\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n6. Patients must have a life expectancy ≥16 weeks\n7. Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on Day 1 of Part A.\n\n Postmenopausal is defined as:\n * Age ≥ 60 years\n * Age \\<60 years and amenorrheic for 1 year or more in the absence of chemotherapy and/or hormonal treatment\n * Luteinising hormone (LH), follicle stimulating hormone (FSH) and plasma oestradiol levels in the postmenopausal range for women under 60 years\n * Radiation-induced oophorectomy with last menses \\>1 year ago\n * Or surgical sterilisation (bilateral oophorectomy or hysterectomy)\n8. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment, and scheduled visits and examinations\n9. Patients must be on stable concomitant medication regimen (with the exception of electrolyte supplements), defined as no change in medication or dose within 2 weeks prior to start of study treatment.\n\nExclusion Criteria:\n\n1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff, its agents, and/or staff at the study site)\n2. Previous enrolment in the present study\n3. Exposure to an investigational product (IP) (including PARP inhibitor) within 30 days or 5 half lives (whichever is the longer) prior to enrolment\n4. Prior chemotherapy within 3 weeks of study entry\n5. Prior radiotherapy within 2 weeks of study entry\n6. If prior endocrine treatment is given, adequate washout period is required: at least 2 weeks for anastrozole, at least 4 weeks for letrozole and at least 10 weeks for tamoxifen\n7. Resting ECG with QTc \\>470 msec detected on 2 or more time points within a 24 hour period, or family history of long QT syndrome. If ECG demonstrates QTc \\>470 msec, patient will be eligible only if repeat ECG demonstrates QTc \\<470 msec.\n8. Patients who are receiving inhibitors or inducers of CYP3A4 unless washed out prior to start of study treatment.\n9. Persistent toxicities (Common Toxicity Criteria for Adverse Events \\[CTCAE\\] grade ≥2) caused by previous cancer therapy, excluding alopecia and/or CTCAE grade 2 peripheral neuropathy\n10. Patients with myelodysplastic syndrome/acute myeloid leukaemia\n11. Major surgery within 2 weeks of starting study treatment: patients must have recovered from any effects of any major surgery\n12. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled seizures or active uncontrolled infection.\n13. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders or significant gastrointestinal resection likely to interfere with absorption of the study medication\n14. Patients who have gastric, gastro-oesophageal, or oesophageal cancer\n15. Pregnant or breastfeeding women\n16. Patients with known active Hepatitis B or C, or human immunodeficiency virus (HIV).\n17. Patients with a known hypersensitivity to olaparib (all cohorts), tamoxifen (Cohort 1) anastrozole (Cohort 2), letrozole (Cohort 3), or any of the excipients of these products."}, 'identificationModule': {'nctId': 'NCT02093351', 'briefTitle': 'To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-Label, Non-randomised, Parallel Group, Multicentre, Phase I Study to Assess the Safety and Effect of Olaparib at Steady State on the Pharmacokinetics of the Anti-hormonal Agents Anastrozole, Letrozole and Tamoxifen at Steady State, and the Effect of the Anti-hormonal Agents on Olaparib, Following Administration in Patients With Advanced Solid Cancer', 'orgStudyIdInfo': {'id': 'D081CC00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - Tamoxifen', 'description': 'Olaparib-alone Steady state PK, Tamoxifen-alone steady state PK, Combined olaparib and Tamoxifen steady state PK.', 'interventionNames': ['Drug: Olaparib', 'Drug: Tamoxifen', 'Procedure: Pharmacokinetic sampling']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - Anastrozole', 'description': 'Olaparib-alone Steady state PK, Anastrozole-alone steady state PK, Combined olaparib and Anastrozole steady state PK.', 'interventionNames': ['Drug: Olaparib', 'Drug: Anastrozole', 'Procedure: Pharmacokinetic sampling']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 - Letrozole', 'description': 'Olaparib-alone Steady state PK, Letrozole-alone steady state PK, Combined olaparib and Letrozole steady state PK.', 'interventionNames': ['Drug: Olaparib', 'Drug: Letrozole', 'Procedure: Pharmacokinetic sampling']}], 'interventions': [{'name': 'Olaparib', 'type': 'DRUG', 'description': '2 x 150mg tablets, twice daily Day 1-5, and Day 27 onwards (Cohort 1), Day 20 onwards (Cohort 2) or Day 39 onwards (Cohort 3)', 'armGroupLabels': ['Cohort 1 - Tamoxifen', 'Cohort 2 - Anastrozole', 'Cohort 3 - Letrozole']}, {'name': 'Tamoxifen', 'type': 'DRUG', 'description': '60mg Tamoxifen once daily, Day 10 - Day 13; 20mg Tamoxifen once daily, Day 14 - Day 31', 'armGroupLabels': ['Cohort 1 - Tamoxifen']}, {'name': 'Anastrozole', 'type': 'DRUG', 'description': '1mg Anastrozole once daily Day 10 - Day 24', 'armGroupLabels': ['Cohort 2 - Anastrozole']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': '2.5mg Letrozole once daily Day 10 - Day 43', 'armGroupLabels': ['Cohort 3 - Letrozole']}, {'name': 'Pharmacokinetic sampling', 'type': 'PROCEDURE', 'description': 'Blood sampling over 12-24 hour period for pharmacokinetic analysis', 'armGroupLabels': ['Cohort 1 - Tamoxifen', 'Cohort 2 - Anastrozole', 'Cohort 3 - Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Research Site', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': 'SE1 9RT', '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': 'Tsveta Milenkova', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Ruth Plummer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sir Bobby Robson Cancer Trials Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}