Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT02163733
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2014-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596361', 'term': 'osimertinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Dr Karen So', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'The Principal Investigator (PI) agrees to collaborate on the contents and formation of any publication and to pay due consideration to comments and opinions offered. AstraZeneca have 30 days for final manuscript review and may require that submission for publication be delayed in order to file patent application.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'At end of Part B, the CAP allowed patients to continue receiving AZD9291 if still deriving clinical benefit. No clinical data was databased during the CAP; thus AE data is presented to end of Part B only.'}}, 'adverseEventsModule': {'timeFrame': 'Approximately 2 weeks for Part A; up to approximately 15 months for Part B and approximately 15.5 months for Overall (Parts A and B combined).', 'description': 'Part A: Adverse events (AEs) collected from day of first dose until day prior to first dose in Part B (Day 15), or until 30 days after last dose if discontinued in Part A. Part B: AEs collected from day of first dose in Part B until 30 days after last dose, or until last dose in Part B for those entering continued access phase (CAP).', 'eventGroups': [{'id': 'EG000', 'title': 'Overall Safety Population', 'description': 'Parts A and B of the study combined.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 38, 'seriousNumAtRisk': 38, 'deathsNumAffected': 2, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Part A Safety Population', 'description': 'In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients were randomised to either Sequence 1 (AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2) or Sequence 2 (AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2).', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 20, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part B Safety Population', 'description': 'In Part B of the study, each patient received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 37, 'seriousNumAtRisk': 38, 'deathsNumAffected': 2, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'BLEPHARITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'DRY EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'LACRIMATION INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'VISUAL ACUITY REDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'DENTAL CARIES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 45, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 41, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 17, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'ORAL CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'PARONYCHIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'BALANCE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'POLLAKIURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'PRODUCTIVE COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'DERMATITIS ACNEIFORM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'NAIL RIDGING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'RASH ERYTHEMATOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'RASH MACULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'RASH MACULO-PAPULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION BACTERIAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'NEUTROPENIC SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'PNEUMONIA', 'notes': 'Death in 1 subject (same subject as Sepsis fatal outcome SAE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'PNEUMONIA PNEUMOCOCCAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'SEPSIS', 'notes': 'Death (same subject as Pneumonia fatal outcome SAE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'INTERVERTEBRAL DISC COMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'CANCER PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'RESPIRATORY DISTRESS', 'notes': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC(0-72) of AZD9291', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'categories': [{'measurements': [{'value': '7403', 'groupId': 'OG000', 'lowerLimit': '3170', 'upperLimit': '15600'}, {'value': '7345', 'groupId': 'OG001', 'lowerLimit': '3400', 'upperLimit': '14700'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.05', 'ciLowerLimit': '94.82', 'ciUpperLimit': '118.60', 'estimateComment': 'Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. Least squares geometric mean ratio (LSGMR) Fed = 7847, Fasted = 7399.', 'groupDescription': 'Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': '90% CIs being within 70% to 143%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 72 hours.', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>5% of Cmax).'}, {'type': 'PRIMARY', 'title': 'Cmax of AZD9291', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'categories': [{'measurements': [{'value': '199.6', 'groupId': 'OG000', 'lowerLimit': '80.8', 'upperLimit': '446'}, {'value': '218.0', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '381'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.75', 'ciLowerLimit': '81.40', 'ciUpperLimit': '105.68', 'estimateComment': 'Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. LSGMR Fed = 208.0, Fasted = 224.3.', 'groupDescription': 'Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': '90% CIs being within 70% to 143%'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients had at least 1 dose AZD9291 and had sufficient postdose PK to determine parameter without important protocol deviations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>5% of Cmax). Note 1 patient missing key 8 hour sample so not included in Cmax analysis.'}, {'type': 'SECONDARY', 'title': 'AUC of AZD9291', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'categories': [{'measurements': [{'value': '11640', 'groupId': 'OG000', 'lowerLimit': '5460', 'upperLimit': '24100'}, {'value': '12530', 'groupId': 'OG001', 'lowerLimit': '6050', 'upperLimit': '25500'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Area under the plasma concentration curve from zero extrapolated to infinity.', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>5% of Cmax).'}, {'type': 'SECONDARY', 'title': 'AUC(0-t) of AZD9291', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'categories': [{'measurements': [{'value': '10820', 'groupId': 'OG000', 'lowerLimit': '4860', 'upperLimit': '21800'}, {'value': '10630', 'groupId': 'OG001', 'lowerLimit': '5300', 'upperLimit': '22600'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Area under the plasma concentration curve from time zero to last quantifiable dose.', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>5% of Cmax).'}, {'type': 'SECONDARY', 'title': 'AUC(0-120) of AZD9291', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'categories': [{'measurements': [{'value': '9549', 'groupId': 'OG000', 'lowerLimit': '4360', 'upperLimit': '18800'}, {'value': '9308', 'groupId': 'OG001', 'lowerLimit': '4480', 'upperLimit': '18900'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours.', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>5% of Cmax).'}, {'type': 'SECONDARY', 'title': 'Tmax of AZD9291', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'categories': [{'measurements': [{'value': '7.97', 'groupId': 'OG000', 'lowerLimit': '3.02', 'upperLimit': '24.13'}, {'value': '6.08', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '10.07'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZD9291 by assessment of time to Cmax.', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>5% of Cmax).'}, {'type': 'SECONDARY', 'title': 't1/2 of AZD9291', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'categories': [{'measurements': [{'value': '52.82', 'groupId': 'OG000', 'lowerLimit': '32.1', 'upperLimit': '84.4'}, {'value': '54.64', 'groupId': 'OG001', 'lowerLimit': '31.2', 'upperLimit': '84.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZD9291 by assessment of the terminal half-life.', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>5% of Cmax).'}, {'type': 'SECONDARY', 'title': 'CL/F of AZD9291', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'categories': [{'measurements': [{'value': '13.75', 'groupId': 'OG000', 'lowerLimit': '6.65', 'upperLimit': '29.3'}, {'value': '12.78', 'groupId': 'OG001', 'lowerLimit': '6.28', 'upperLimit': '26.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>5% of Cmax).'}, {'type': 'SECONDARY', 'title': 'Vz/F of AZD9291', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'categories': [{'measurements': [{'value': '1024', 'groupId': 'OG000', 'lowerLimit': '470', 'upperLimit': '2580'}, {'value': '1019', 'groupId': 'OG001', 'lowerLimit': '432', 'upperLimit': '2200'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution.', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>5% of Cmax).'}, {'type': 'SECONDARY', 'title': 'AUC(0-72) of AZ5104 and AZ7550', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'title': 'AZ5104', 'categories': [{'measurements': [{'value': '497.6', 'groupId': 'OG000', 'lowerLimit': '138', 'upperLimit': '1360'}, {'value': '613.2', 'groupId': 'OG001', 'lowerLimit': '270', 'upperLimit': '1450'}]}]}, {'title': 'AZ7550', 'categories': [{'measurements': [{'value': '235.0', 'groupId': 'OG000', 'lowerLimit': '82.7', 'upperLimit': '1140'}, {'value': '266.4', 'groupId': 'OG001', 'lowerLimit': '112', 'upperLimit': '590'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '81.15', 'ciLowerLimit': '57.86', 'ciUpperLimit': '113.83', 'estimateComment': 'Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 497.6, Fasted = 613.2.', 'groupDescription': 'AZ5104', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '88.21', 'ciLowerLimit': '65.21', 'ciUpperLimit': '119.32', 'estimateComment': 'Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 235.0, Fasted = 266.4.', 'groupDescription': 'AZ7550', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 72 hours.', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>10% of Cmax for respective metabolite).'}, {'type': 'SECONDARY', 'title': 'Cmax of AZ5104 and AZ7550', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'title': 'AZ5104', 'categories': [{'measurements': [{'value': '9.163', 'groupId': 'OG000', 'lowerLimit': '2.94', 'upperLimit': '24.7'}, {'value': '11.95', 'groupId': 'OG001', 'lowerLimit': '4.95', 'upperLimit': '28.6'}]}]}, {'title': 'AZ7550', 'categories': [{'measurements': [{'value': '4.236', 'groupId': 'OG000', 'lowerLimit': '1.76', 'upperLimit': '19.7'}, {'value': '5.109', 'groupId': 'OG001', 'lowerLimit': '1.78', 'upperLimit': '11.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '76.68', 'ciLowerLimit': '55.31', 'ciUpperLimit': '106.32', 'estimateComment': 'Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 9.163, Fasted = 11.95.', 'groupDescription': 'AZ5104', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '82.92', 'ciLowerLimit': '60.99', 'ciUpperLimit': '112.74', 'estimateComment': 'Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 4.236, Fasted = 5.109.', 'groupDescription': 'AZ7550', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of maximum plasma concentration.', 'unitOfMeasure': 'nM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>10% of Cmax for respective metabolite).'}, {'type': 'SECONDARY', 'title': 'AUC(0-t) of AZ5104 and AZ7550', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'title': 'AZ5104', 'categories': [{'measurements': [{'value': '1033', 'groupId': 'OG000', 'lowerLimit': '266', 'upperLimit': '2590'}, {'value': '1132', 'groupId': 'OG001', 'lowerLimit': '535', 'upperLimit': '2640'}]}]}, {'title': 'AZ7550', 'categories': [{'measurements': [{'value': '584.5', 'groupId': 'OG000', 'lowerLimit': '178', 'upperLimit': '2530'}, {'value': '591.9', 'groupId': 'OG001', 'lowerLimit': '270', 'upperLimit': '1090'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Area under the plasma concentration curve from time zero to last quantifiable dose for AZ5104 and AZ7550 (metabolites to AZD9291).', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>10% of Cmax for respective metabolite).'}, {'type': 'SECONDARY', 'title': 'AUC(0-120) of AZ5104 and AZ7550', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'title': 'AZ5104', 'categories': [{'measurements': [{'value': '744.4', 'groupId': 'OG000', 'lowerLimit': '206', 'upperLimit': '2050'}, {'value': '875.7', 'groupId': 'OG001', 'lowerLimit': '408', 'upperLimit': '1940'}]}]}, {'title': 'AZ7550', 'categories': [{'measurements': [{'value': '373.4', 'groupId': 'OG000', 'lowerLimit': '127', 'upperLimit': '1820'}, {'value': '411.4', 'groupId': 'OG001', 'lowerLimit': '178', 'upperLimit': '850'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 120 hours.', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>10% of Cmax for respective metabolite).'}, {'type': 'SECONDARY', 'title': 'Tmax of AZ5104 and AZ7550', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'title': 'AZ5104', 'categories': [{'measurements': [{'value': '24.17', 'groupId': 'OG000', 'lowerLimit': '8.08', 'upperLimit': '72.75'}, {'value': '8.03', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '49.03'}]}]}, {'title': 'AZ7550', 'categories': [{'measurements': [{'value': '24.60', 'groupId': 'OG000', 'lowerLimit': '8.08', 'upperLimit': '120.58'}, {'value': '10.00', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '73.53'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of time to Cmax.', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>10% of Cmax for respective metabolite).'}, {'type': 'SECONDARY', 'title': 't1/2 of AZ5104 and AZ7550', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed (High-fat Meal)', 'description': 'AZD9291 tablets following a high-fat meal'}, {'id': 'OG001', 'title': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting'}], 'classes': [{'title': 'AZ5104', 'categories': [{'measurements': [{'value': '64.74', 'groupId': 'OG000', 'lowerLimit': '45.9', 'upperLimit': '113'}, {'value': '62.89', 'groupId': 'OG001', 'lowerLimit': '43.3', 'upperLimit': '96.2'}]}]}, {'title': 'AZ7550', 'categories': [{'measurements': [{'value': '85.26', 'groupId': 'OG000', 'lowerLimit': '52.2', 'upperLimit': '142'}, {'value': '91.54', 'groupId': 'OG001', 'lowerLimit': '58.2', 'upperLimit': '204'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of the terminal half-life.', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration \\>10% of Cmax for respective metabolite).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fed/Fasted', 'description': 'In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.'}, {'id': 'FG001', 'title': 'Fasted/Fed', 'description': 'In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.'}, {'id': 'FG002', 'title': 'AZD9291 Alone (Part B)', 'description': 'In Part B of the study, each patient (who completed Part A) received 80 mg oral AZD9291 tablet formulation once daily, for the duration of their participation.'}], 'periods': [{'title': 'Part A: Day 1-9 (1st Intervention)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part A: Day 10-15 (2nd Intervention)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Part B: Day 15 to End Part B (AZD9291)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Only the AZD9291 once daily (Part B) arm is applicable for this period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Only the AZD9291 once daily (Part B) arm is applicable for this period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'No patients completed previous period as relates to Part A and arm is applicable only for Part B.', 'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'First subject enrolled: 14 November 2014; Last Subject Last Visit for Part A: 23 March 2015 and Part B: 22 March 2016. The study was performed at 12 sites across Asia and Western Europe. Part A determined effect of food on PK of AZD9291; Part B allowed subjects further access to AZD9291 and provided additional safety data.', 'preAssignmentDetails': '43 subjects were enrolled (signed informed consent). Subjects were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 5 subjects were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 38 subjects started Period 1 and received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fed/Fasted', 'description': 'In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fed/Fasted treatment group followed Sequence 1: AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.'}, {'id': 'BG001', 'title': 'Fasted/Fed', 'description': 'In Part A of the study, each patient received a single 80 mg oral AZD9291 tablet dose in each of 2 treatment periods. Patients who were randomised to the Fasted/Fed treatment group followed Sequence 2: AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'spread': '11.98', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '11.00', 'groupId': 'BG001'}, {'value': '62.7', 'spread': '11.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2014-05-29', 'resultsFirstSubmitDate': '2016-03-03', 'studyFirstSubmitQcDate': '2014-06-12', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-03', 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(0-72) of AZD9291', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 72 hours.'}, {'measure': 'Cmax of AZD9291', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration.'}], 'secondaryOutcomes': [{'measure': 'AUC of AZD9291', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Area under the plasma concentration curve from zero extrapolated to infinity.'}, {'measure': 'AUC(0-t) of AZD9291', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Area under the plasma concentration curve from time zero to last quantifiable dose.'}, {'measure': 'AUC(0-120) of AZD9291', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours.'}, {'measure': 'Tmax of AZD9291', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZD9291 by assessment of time to Cmax.'}, {'measure': 't1/2 of AZD9291', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZD9291 by assessment of the terminal half-life.'}, {'measure': 'CL/F of AZD9291', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration.'}, {'measure': 'Vz/F of AZD9291', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution.'}, {'measure': 'AUC(0-72) of AZ5104 and AZ7550', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 72 hours.'}, {'measure': 'Cmax of AZ5104 and AZ7550', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of maximum plasma concentration.'}, {'measure': 'AUC(0-t) of AZ5104 and AZ7550', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Area under the plasma concentration curve from time zero to last quantifiable dose for AZ5104 and AZ7550 (metabolites to AZD9291).'}, {'measure': 'AUC(0-120) of AZ5104 and AZ7550', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 120 hours.'}, {'measure': 'Tmax of AZ5104 and AZ7550', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of time to Cmax.'}, {'measure': 't1/2 of AZ5104 and AZ7550', 'timeFrame': 'Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.', 'description': 'Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of the terminal half-life.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['oncology, cancer, non small cell lung cancer, anticancer drug, pharmacokinetics, AZD9291, EGFR sensitivity mutation, food effect'], 'conditions': ['Advanced Non Small Cell Lung Cancer', 'Advanced (Inoperable) Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '29178442', 'type': 'DERIVED', 'citation': 'Vishwanathan K, Dickinson PA, Bui K, Cassier PA, Greystoke A, Lisbon E, Moreno V, So K, Thomas K, Weilert D, Yap TA, Plummer R. The Effect of Food or Omeprazole on the Pharmacokinetics of Osimertinib in Patients With Non-Small-Cell Lung Cancer and in Healthy Volunteers. J Clin Pharmacol. 2018 Apr;58(4):474-484. doi: 10.1002/jcph.1035. Epub 2017 Nov 26.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2987&filename=Study9_Redacted.pdf', 'label': 'Study9\\_Redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5160C00009&attachmentIdentifier=4f5d7dd7-6acc-4e98-8414-3323c1167aca&fileName=CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'CSR Synopsis Redacted'}]}, 'descriptionModule': {'briefSummary': 'This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow patients further access to AZD9291 and will provide for additional safety data collection.\n\nPart A is a randomised, open-label, 2 treatment period crossover study in which patients will each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time (approximately 0800) in each of 2 treatment periods (once immediately following a high fat meal \\[fed\\], and once in the fasted state \\[fasted\\]), with a washout period of 9 days between doses.\n\nApproximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2 \\[TP 2\\] has been collected). Additional patients may be enrolled to allow for at least 30 evaluable patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "For inclusion in the study patients should fulfil the following criteria:\n\n1. Male or female, aged at least 18 years.\n2. Able to eat a high-fat meal within a 30-minute period, as provided by the study site.\n3. Histologically or, where appropriate, cytologically confirmed NSCLC.\n4. Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI. In addition, other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.\n5. Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).\n6. ECOG performance status 0-1 with no deterioration over the previous 2 weeks.\n7. Patients must have a life expectancy of ≥12 weeks, as estimated at the time of screening.\n8. Females should be using adequate contraceptive measures and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments; Women under 50 years old would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution; Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation.\n9. Male patients should be willing to use barrier contraception, ie, condoms, until 6 months after last study drug is taken.\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Participation in another clinical study with an IP during the last 14 days (or a longer period depending on the defined characteristics of the agents used).\n2. Treatment with any of the following: Treatment with an EGFR TKI w/in 8 days or approximately 5x half-life, whichever is the longer, of the first dose of study treatment; Any cytotoxic chemotherapy, investigational agents or other anticancer drugs w/in 14 days of the first dose of study treatment; Major surgery (excluding placement of vascular access) within 4 weeks of the first dose; Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks of the first dose of study treatment; Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP2C8 and of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer/inhibitory effects on CYP3A4, CYP2C8, and/ or CYP1A2.\n3. Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of the IP until the end of Part A.\n4. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum therapy related neuropathy.\n5. Patients unable to fast for up to 14 hours.\n6. Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment.\n7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus. Screening for chronic conditions is not required.\n8. Patients with type I diabetes.\n9. Patients unable to swallow orally administered medication or patients with gastrointestinal disorders or significant gastrointestinal resection likely to interfere with the absorption of AZD9291.\n10. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n11. Women who are breastfeeding.\n12. Patients with a known hypersensitivity to AZD9291\n13. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: Absolute neutrophil count (ANC) \\<1.5 x 109/L; Platelet count \\<100 x 109/L; Haemoglobin \\<90 g/L; ALT \\>2.5 x the institutional ULN if no demonstrable liver metastases or \\>5 x institutional ULN in the presence of liver metastases; AST \\>2.5 x institutional ULN if no demonstrable liver metastases or \\>5 x institutional ULN in the presence of liver metastases; Total bilirubin \\>1.5 x institutional ULN if no liver metastases or \\>3 x institutional ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases; Creatinine \\>1.5 x institutional ULN concurrent with creatinine clearance \\<50 mL/min (measured or calculated by Cockcroft-Gault formula); confirmation of creatinine clearance is only required when creatinine is \\>1.5 x institutional ULN.\n14. Any of the following cardiac criteria: Mean resting corrected QT interval corrected for heart rate using Fridericia's correction factor (QTcF) \\>470 msec obtained from 3 ECGs; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 msec; Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval.\n15. For optional genetic research: Previous allogenic bone marrow transplant or non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection."}, 'identificationModule': {'nctId': 'NCT02163733', 'briefTitle': 'Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-label, Randomised, Phase I, Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI', 'orgStudyIdInfo': {'id': 'D5160C00009'}, 'secondaryIdInfos': [{'id': '2014-001556-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fasted', 'description': 'AZD9291 tablets following a period of fasting', 'interventionNames': ['Drug: AZD9291 tablets', 'Procedure: Pharmacokinetic sampling - AZD9291', 'Other: Dietary Fasted', 'Procedure: Pharmacokinetic sampling - AZ5140 and AZ7550']}, {'type': 'OTHER', 'label': 'High-fat meal', 'description': 'AZD9291 tablets following a high-fat meal.', 'interventionNames': ['Drug: AZD9291 tablets', 'Procedure: Pharmacokinetic sampling - AZD9291', 'Other: Dietary High Fat', 'Procedure: Pharmacokinetic sampling - AZ5140 and AZ7550']}], 'interventions': [{'name': 'AZD9291 tablets', 'type': 'DRUG', 'description': 'AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months.', 'armGroupLabels': ['Fasted', 'High-fat meal']}, {'name': 'Pharmacokinetic sampling - AZD9291', 'type': 'PROCEDURE', 'description': 'Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.', 'armGroupLabels': ['Fasted', 'High-fat meal']}, {'name': 'Dietary Fasted', 'type': 'OTHER', 'description': 'Fasted from 10 hours prior to dosing with 80mg AZD9291 tablet and 4 hours after dosing', 'armGroupLabels': ['Fasted']}, {'name': 'Dietary High Fat', 'type': 'OTHER', 'description': 'Allocated breakfast prior to dosing with 80mg AZD9291 tablet', 'armGroupLabels': ['High-fat meal']}, {'name': 'Pharmacokinetic sampling - AZ5140 and AZ7550', 'type': 'PROCEDURE', 'description': 'Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.', 'armGroupLabels': ['Fasted', 'High-fat meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'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': 'Serban Ghiorghiu, MSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}