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Ignite Creation Date: 2025-12-26 @ 5:22 PM

Ignite Modification Date: 2026-02-21 @ 8:59 AM

Study NCT ID: NCT02511106

Status: ACTIVE_NOT_RECRUITING

Last Update Posted: 2025-08-28

First Post: 2015-07-28

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Norway']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596361', 'term': 'osimertinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '+447920183730', 'title': 'Global Clinical Leader', 'organization': 'AstraZeneca AB'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Primary analysis was performed two years early as per IDMC recommendation and the exploratory analysis of final DFS data at the prespecified maturity of approx. 50% was done in 2022. After the final DFS data analysis and until the final OS analysis, only limited data were collected: subsequent anti-cancer treatment, survival status and limited safety data. The AZ7550 metabolite samples were not analyzed after Mar 2019, so the ratio of metabolite to AZD9291 was not available for calculation.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.', 'description': 'Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants.\n\nThe remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'AZD9291', 'description': 'Description (Arm-group)', 'otherNumAtRisk': 337, 'deathsNumAtRisk': 339, 'otherNumAffected': 312, 'seriousNumAtRisk': 337, 'deathsNumAffected': 42, 'seriousNumAffected': 68}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Description (Arm-group)', 'otherNumAtRisk': 343, 'deathsNumAtRisk': 343, 'otherNumAffected': 262, 'seriousNumAtRisk': 343, 'deathsNumAffected': 82, 'seriousNumAffected': 47}], 'otherEvents': [{'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 38, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 49, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 86, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 74, 'numAffected': 61}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 49, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 95, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 88, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 42, 'numAffected': 30}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 47, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 20, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 41, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 29, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 309, 'numAffected': 158}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 114, 'numAffected': 71}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 44, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 82, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 102, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 25, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 43, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 27, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 45, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 47, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 118, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 74, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 145, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 83, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 54, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 37, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 32, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 33, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 41, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Electrocardiogram qt prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 49, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 48, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 36, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 53, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 55, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 42, 'numAffected': 37}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 37, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Neck mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bladder cancer stage 0, with cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Myeloproliferative neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Transitional cell 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Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.906', 'spread': '10.181', 'groupId': 'OG000'}, {'value': '2.778', 'spread': '11.295', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 - Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.045', 'spread': '11.410', 'groupId': 'OG000'}, {'value': '3.324', 'spread': '10.258', 'groupId': 'OG001'}]}]}, {'title': 'Week 156 - Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.552', 'spread': '11.994', 'groupId': 'OG000'}, {'value': '3.116', 'spread': '10.692', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 - General Health Perceptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.597', 'spread': '8.319', 'groupId': 'OG000'}, {'value': '0.343', 'spread': '7.497', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 - 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Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.637', 'spread': '8.220', 'groupId': 'OG000'}, {'value': '2.016', 'spread': '7.048', 'groupId': 'OG001'}]}]}, {'title': 'Week 120 - Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.449', 'spread': '7.207', 'groupId': 'OG000'}, {'value': '2.540', 'spread': '7.424', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 - Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.869', 'spread': '6.767', 'groupId': 'OG000'}, {'value': '1.939', 'spread': '8.238', 'groupId': 'OG001'}]}]}, {'title': 'Week 156 - Physical functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.997', 'spread': '7.537', 'groupId': 'OG000'}, {'value': '2.187', 'spread': '8.293', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 - 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Role Limitations - Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.240', 'spread': '10.807', 'groupId': 'OG000'}, {'value': '5.321', 'spread': '9.997', 'groupId': 'OG001'}]}]}, {'title': 'Week 120 - Role Limitations - Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.717', 'spread': '11.238', 'groupId': 'OG000'}, {'value': '5.348', 'spread': '11.395', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 - Role Limitations - Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.525', 'spread': '10.860', 'groupId': 'OG000'}, {'value': '5.444', 'spread': '10.547', 'groupId': 'OG001'}]}]}, {'title': 'Week 156 - Role Limitations - Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.151', 'spread': '11.378', 'groupId': 'OG000'}, {'value': '5.572', 'spread': '10.954', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.391', 'spread': '9.615', 'groupId': 'OG000'}, {'value': '3.164', 'spread': '9.171', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.634', 'spread': '9.526', 'groupId': 'OG000'}, {'value': '3.433', 'spread': '10.348', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.731', 'spread': '9.919', 'groupId': 'OG000'}, {'value': '4.170', 'spread': '10.156', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.025', 'spread': '10.094', 'groupId': 'OG000'}, {'value': '4.802', 'spread': '10.351', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.651', 'spread': '10.011', 'groupId': 'OG000'}, {'value': '4.405', 'spread': '10.790', 'groupId': 'OG001'}]}]}, {'title': 'Week 120 - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.297', 'spread': '10.723', 'groupId': 'OG000'}, {'value': '4.386', 'spread': '11.355', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.582', 'spread': '10.638', 'groupId': 'OG000'}, {'value': '3.912', 'spread': '10.929', 'groupId': 'OG001'}]}]}, {'title': 'Week 156 - Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.423', 'spread': '10.658', 'groupId': 'OG000'}, {'value': '4.351', 'spread': '12.144', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.570', 'spread': '7.987', 'groupId': 'OG000'}, {'value': '2.344', 'spread': '8.207', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.630', 'spread': '8.996', 'groupId': 'OG000'}, {'value': '2.463', 'spread': '9.461', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.231', 'spread': '9.209', 'groupId': 'OG000'}, {'value': '3.029', 'spread': '8.972', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.082', 'spread': '9.387', 'groupId': 'OG000'}, {'value': '3.815', 'spread': '8.869', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.147', 'spread': '9.052', 'groupId': 'OG000'}, {'value': '3.474', 'spread': '9.071', 'groupId': 'OG001'}]}]}, {'title': 'Week 120 - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.139', 'spread': '9.458', 'groupId': 'OG000'}, {'value': '3.224', 'spread': '9.122', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.386', 'spread': '9.724', 'groupId': 'OG000'}, {'value': '2.070', 'spread': '9.285', 'groupId': 'OG001'}]}]}, {'title': 'Week 156 - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.825', 'spread': '9.342', 'groupId': 'OG000'}, {'value': '2.970', 'spread': '8.831', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 - Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.986', 'spread': '8.068', 'groupId': 'OG000'}, {'value': '2.603', 'spread': '8.965', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 - Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.333', 'spread': '8.919', 'groupId': 'OG000'}, {'value': '1.936', 'spread': '10.152', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 - Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.788', 'spread': '9.301', 'groupId': 'OG000'}, {'value': '2.757', 'spread': '9.141', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 - Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.434', 'spread': '9.635', 'groupId': 'OG000'}, {'value': '2.577', 'spread': '9.116', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 - Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.823', 'spread': '9.439', 'groupId': 'OG000'}, {'value': '2.415', 'spread': '10.023', 'groupId': 'OG001'}]}]}, {'title': 'Week 120 - Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.027', 'spread': '10.286', 'groupId': 'OG000'}, {'value': '2.554', 'spread': '10.548', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 - Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.580', 'spread': '9.994', 'groupId': 'OG000'}, {'value': '1.870', 'spread': '9.857', 'groupId': 'OG001'}]}]}, {'title': 'Week 156 - Mental Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.322', 'spread': '10.077', 'groupId': 'OG000'}, {'value': '2.269', 'spread': '10.647', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 - Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.161', 'spread': '6.341', 'groupId': 'OG000'}, {'value': '1.144', 'spread': '6.078', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 - Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.878', 'spread': '7.009', 'groupId': 'OG000'}, {'value': '1.938', 'spread': '6.643', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 - Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.356', 'spread': '6.800', 'groupId': 'OG000'}, {'value': '2.797', 'spread': '7.497', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 - Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.989', 'spread': '6.941', 'groupId': 'OG000'}, {'value': '3.360', 'spread': '6.985', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 - Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.497', 'spread': '7.591', 'groupId': 'OG000'}, {'value': '3.343', 'spread': '6.792', 'groupId': 'OG001'}]}]}, {'title': 'Week 120 - Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.611', 'spread': '7.291', 'groupId': 'OG000'}, {'value': '3.175', 'spread': '8.210', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 - Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.635', 'spread': '7.374', 'groupId': 'OG000'}, {'value': '3.353', 'spread': '8.042', 'groupId': 'OG001'}]}]}, {'title': 'Week 156 - Physical Component Summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.133', 'spread': '7.909', 'groupId': 'OG000'}, {'value': '3.644', 'spread': '8.731', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years.', 'description': 'Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health.', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of AZD9291', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD9291 80mg Tablet', 'description': 'Taken once daily'}], 'classes': [{'title': 'Week 4 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '380.2563', 'spread': '60.4465', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '383.9142', 'spread': '74.3191', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '463.0098', 'spread': '56.3562', 'groupId': 'OG000'}]}]}, {'title': 'Week 24- Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '288.8266', 'spread': '181.8255', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '303.8269', 'spread': '116.9411', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '358.831', 'spread': '116.0567', 'groupId': 'OG000'}]}]}, {'title': 'Week 48- Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '301.7346', 'spread': '125.4901', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '311.3503', 'spread': '101.1574', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '375.6666', 'spread': '69.9838', 'groupId': 'OG000'}]}]}, {'title': 'Week 96- Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '287.5375', 'spread': '95.6634', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '273.3198', 'spread': '126.003', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '341.5805', 'spread': '79.0578', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)', 'description': 'The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291', 'unitOfMeasure': 'nM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of AZ5104 Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZ5104', 'description': 'AZD9291 metabolite'}], 'classes': [{'title': 'Week 4 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.4619', 'spread': '66.2108', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.2280', 'spread': '67.0500', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.6081', 'spread': '65.5757', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.7314', 'spread': '111.0996', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.1687', 'spread': '86.1118', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.3251', 'spread': '99.2633', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.1778', 'spread': '53.8923', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.9276', 'spread': '53.9916', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.9143', 'spread': '68.8102', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.0205', 'spread': '81.4442', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.9723', 'spread': '101.2317', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.8057', 'spread': '78.0300', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From date of dosing to week 96 (approximately 24 months)', 'description': 'The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolites', 'unitOfMeasure': 'nM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of AZ7550 Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZ7550', 'description': 'AZD9291 metabolite'}], 'classes': [{'title': 'Week 4 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.3492', 'spread': '56.5153', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.7386', 'spread': '55.0410', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.0864', 'spread': '61.8700', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.7113', 'spread': '75.3663', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.9375', 'spread': '65.8656', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.1476', 'spread': '60.2684', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.3862', 'spread': '52.2259', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.0467', 'spread': '52.9773', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.4486', 'spread': '99.6574', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.1890', 'spread': '180.0937', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 - 0.5-1.5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.2419', 'spread': '155.4156', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 - 2-4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.9653', 'spread': '79.2841', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From date of dosing to week 96 (approximately 24 months)', 'description': 'The pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolites', 'unitOfMeasure': 'nM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD9291', 'description': 'Taken once daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Taken once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '339'}, {'groupId': 'FG001', 'numSubjects': '343'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '343'}]}, {'type': 'COMPLETED', 'comment': '(Study)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '261'}, {'groupId': 'FG001', 'numSubjects': '234'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '109'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'Ongoing study at data cut-off', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Without specified reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 682 Patients were randomized to treatment at 245 Centers in 25 Countries.', 'preAssignmentDetails': 'During the 28 day screening period, participants were enrolled based on the presence of at least 1 of the 2 most frequent Epidermal growth factor receptor (EGFR) mutations in their tumor. At the time of enrolment, all participant were required to have central confirmation of EGFR mutation status per eligibility criteria (Exon 19 deletion or L858R mutation).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'BG000'}, {'value': '343', 'groupId': 'BG001'}, {'value': '682', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD9291', 'description': 'Taken once daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Taken once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '61.6', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '478', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'ASIAN (OTHER THAN CHINESE AND JAPANESE)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'CHINESE', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}, {'title': 'HISPANIC OR LATINO', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'JAPANESE', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': 'OTHER', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'AMERICAN INDIAN OR ALASKA NATIVE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'ASIAN', 'categories': [{'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '434', 'groupId': 'BG002'}]}]}, {'title': 'BLACK OR AFRICAN AMERICAN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'UNKNOWN OR NOT REPORTED', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'OTHER', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'WHITE', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Hong Kong, S.A.R., China', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan, China', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Viet Nam', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic Of', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-09', 'size': 3564575, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-15T07:20', 'hasProtocol': True}, {'date': '2020-06-23', 'size': 3620937, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-15T05:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 682}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2015-07-28', 'resultsFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-07-06', 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).', 'timeFrame': 'Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)', 'description': 'Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).'}], 'secondaryOutcomes': [{'measure': 'Disease Free Survival (DFS) Rate at 2, 3 and 5 Years', 'timeFrame': 'Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months). DFS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.', 'description': 'Defined as the percentage of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months)', 'description': 'Defined as the time from the date of randomization until date of death due to any cause.'}, {'measure': 'Overall Survival Rate at 2, 3 and 5 Years', 'timeFrame': 'Up to approximately 7 years after the first patient is randomized (maximum follow up of 86 months). OS rate at 2 years (%), 3 years (%) and 5 years (%) are presented.', 'description': 'Defined as the percentage of patients alive at 2, 3 and 5 years, respectively, estimated from a Kaplan Meier plot of OS.'}, {'measure': 'Patient Health-related Quality of Life and Symptoms (HRQoL) by SF-36v2 Health Survey.', 'timeFrame': 'Measured by SF-36 Questionnaire at baseline, 12 week, 24 week and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to 3 years.', 'description': 'Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health.'}, {'measure': 'Plasma Concentrations of AZD9291', 'timeFrame': 'Collected at pre-dose, 0.5-1.5hours and 2-4hours post-dose up to 96 weeks (approximately 24 months)', 'description': 'The pharmacokinetics exposure parameters derived from plasma concentrations of AZD9291'}, {'measure': 'Plasma Concentrations of AZ5104 Metabolites', 'timeFrame': 'From date of dosing to week 96 (approximately 24 months)', 'description': 'The pharmacokinetics exposure parameters derived from plasma concentrations of AZ5104 metabolites'}, {'measure': 'Plasma Concentrations of AZ7550 Metabolites', 'timeFrame': 'From date of dosing to week 96 (approximately 24 months)', 'description': 'The pharmacokinetics exposure parameters derived from plasma concentrations of AZ7550 metabolites'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stage IB-IIA-IIIA Non-Small Cell Lung Cancer; EGFRm+; Ex19Del; L858R; AZD9291; Phase III, adjuvant chemotherapy; complete tumour resection; EGFR-TKI'], 'conditions': ['Stage IB-IIIA Non-small Cell Lung Carcinoma']}, 'referencesModule': {'references': [{'pmid': '33596365', 'type': 'RESULT', 'citation': 'Herbst RS, Wu YL, Tsuboi M. Osimertinib in EGFR-Mutated Lung Cancer. Reply. N Engl J Med. 2021 Feb 18;384(7):675-676. doi: 10.1056/NEJMc2033951. No abstract available.'}, {'pmid': '40311309', 'type': 'DERIVED', 'citation': 'Murat-Onana ML, Ramalingam SS, Janne PA, Gray JE, Ahn MJ, John T, Yatabe Y, Huang X, Rukazenkov Y, Javey M, Brown H, Li-Sucholeiki X. EGFR mutation testing across the osimertinib clinical program. Lung Cancer. 2025 Jun;204:108549. doi: 10.1016/j.lungcan.2025.108549. Epub 2025 Apr 18.'}, {'pmid': '40097663', 'type': 'DERIVED', 'citation': 'Herbst RS, John T, Grohe C, Goldman JW, Kato T, Laktionov K, Bonanno L, Tiseo M, Majem M, Domine M, Ahn MJ, Kowalski DM, Perol M, Sriuranpong V, Ozguroglu M, Bhetariya P, Markovets A, Rukazenkov Y, Muldoon C, Robichaux J, Hartmaier R, Tsuboi M, Wu YL. Molecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB-IIIA non-small-cell lung cancer. Nat Med. 2025 Jun;31(6):1958-1968. doi: 10.1038/s41591-025-03577-y. Epub 2025 Mar 17.'}, {'pmid': '37390376', 'type': 'DERIVED', 'citation': 'Wu D, Li GF. Improving Report of the ADAURA Trial by Distinguishing Treatment-Related Adverse Events From Treatment-Emergent Adverse Events and Assessing Independence of Censoring in Final Disease-Free Survival Analyses. J Clin Oncol. 2023 Sep 10;41(26):4317-4318. doi: 10.1200/JCO.23.00604. Epub 2023 Jun 30. No abstract available.'}, {'pmid': '37272535', 'type': 'DERIVED', 'citation': 'Tsuboi M, Herbst RS, John T, Kato T, Majem M, Grohe C, Wang J, Goldman JW, Lu S, Su WC, de Marinis F, Shepherd FA, Lee KH, Le NT, Dechaphunkul A, Kowalski D, Poole L, Bolanos A, Rukazenkov Y, Wu YL; ADAURA Investigators. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. N Engl J Med. 2023 Jul 13;389(2):137-147. doi: 10.1056/NEJMoa2304594. Epub 2023 Jun 4.'}, {'pmid': '37236398', 'type': 'DERIVED', 'citation': 'John T, Grohe C, Goldman JW, Shepherd FA, de Marinis F, Kato T, Wang Q, Su WC, Choi JH, Sriuranpong V, Melotti B, Fidler MJ, Chen J, Albayaty M, Stachowiak M, Taggart S, Wu YL, Tsuboi M, Herbst RS, Majem M. Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial. J Thorac Oncol. 2023 Sep;18(9):1209-1221. doi: 10.1016/j.jtho.2023.05.015. Epub 2023 May 24.'}, {'pmid': '36720083', 'type': 'DERIVED', 'citation': 'Herbst RS, Wu YL, John T, Grohe C, Majem M, Wang J, Kato T, Goldman JW, Laktionov K, Kim SW, Yu CJ, Vu HV, Lu S, Lee KY, Mukhametshina G, Akewanlop C, de Marinis F, Bonanno L, Domine M, Shepherd FA, Urban D, Huang X, Bolanos A, Stachowiak M, Tsuboi M. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial. J Clin Oncol. 2023 Apr 1;41(10):1830-1840. doi: 10.1200/JCO.22.02186. Epub 2023 Jan 31.'}, {'pmid': '36534268', 'type': 'DERIVED', 'citation': 'John T, Majem M, Legg D, Goldman J. Current and Future Perspectives of Health-Related Quality of Life in Resectable EGFR-Mutated Non-Small Cell Lung Cancer: A Podcast. Target Oncol. 2023 Jan;18(1):1-8. doi: 10.1007/s11523-022-00927-5. Epub 2022 Dec 19. No abstract available.'}, {'pmid': '35012927', 'type': 'DERIVED', 'citation': 'Majem M, Goldman JW, John T, Grohe C, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Li S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Atagi S, Zeng L, Kulkarni D, Medic N, Tsuboi M, Herbst RS, Wu YL. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial. Clin Cancer Res. 2022 Jun 1;28(11):2286-2296. doi: 10.1158/1078-0432.CCR-21-3530.'}, {'pmid': '34740861', 'type': 'DERIVED', 'citation': 'Wu YL, John T, Grohe C, Majem M, Goldman JW, Kim SW, Kato T, Laktionov K, Vu HV, Wang Z, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Atasoy A, Herbst RS, Tsuboi M. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC. J Thorac Oncol. 2022 Mar;17(3):423-433. doi: 10.1016/j.jtho.2021.10.014. Epub 2021 Nov 2.'}, {'pmid': '34723634', 'type': 'DERIVED', 'citation': 'Wu YL, Tsuboi M, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(35):4827-4835. doi: 10.2217/fon-2021-0752. Epub 2021 Nov 1.'}, {'pmid': '32955177', 'type': 'DERIVED', 'citation': 'Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.'}, {'pmid': '29789220', 'type': 'DERIVED', 'citation': 'Wu YL, Herbst RS, Mann H, Rukazenkov Y, Marotti M, Tsuboi M. ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection. Clin Lung Cancer. 2018 Jul;19(4):e533-e536. doi: 10.1016/j.cllc.2018.04.004. Epub 2018 May 1.'}], 'seeAlsoLinks': [{'url': 'http://www.nlm.nih.gov/medlineplus/cancer.html', 'label': 'Cancer'}, {'url': 'http://www.nlm.nih.gov/medlineplus/lungcancer.html', 'label': 'Lung Cancer'}, {'url': 'http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&query=EGFR+mutation&x=20&y=19', 'label': 'EGFR mutation'}, {'url': 'http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&v%3Asources=medlineplus-bundle&query=stage+IB+non-small+cell+lung+cancer', 'label': 'Stage IB non-small cell lung cancer'}, {'url': 'http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&v%3Asources=medlineplus-bundle&query=Stage+II+non-small+cell+lung+cancer', 'label': 'Stage II non-small cell lung cancer'}, {'url': 'http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&v%3Asources=medlineplus-bundle&query=Stage+IIIA+non-small+cell+lung+cancer', 'label': 'Stage IIIA non-small cell lung cancer'}, {'url': 'http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&v%3Asources=medlineplus-bundle&query=adjuvant+chemotherapy+in+non-small+cancer', 'label': 'Adjuvant chemotherapy in non-small cancer'}, {'url': 'http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&v%3Asources=medlineplus-bundle&query=complete+tumour+resection+in+non-small+cancer', 'label': 'Complete tumour resection in non-small cancer'}, {'url': 'http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&v%3Asources=medlineplus-bundle&query=EGFR+sensitivity', 'label': 'EGFR sensitivity'}, {'url': 'http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v%3Aproject=medlineplus&v%3Asources=medlineplus-bundle&query=EGFR+inhibitors', 'label': 'EGFR inhibitors'}, {'url': 'http://clinicaltrials.gov/ct2/info/fdalinks', 'label': 'FDA Drug and Device Resources'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5164C00001&attachmentIdentifier=bb565084-81da-44b1-b70c-083b742cd562&fileName=SAP_redacted_D5164C00001.pdf&versionIdentifier=', 'label': 'Redacted SAP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5164C00001&attachmentIdentifier=e85e833e-fe2c-45c1-a278-7c9b023fd78e&fileName=D5164C00001_CSR-Synopsis.pdf&versionIdentifier=', 'label': 'CSR Synopsis'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5164C00001&attachmentIdentifier=fe73ecf5-8e7e-4f5e-9118-e6a825cdffda&fileName=D5164C00001-CSR-addendum1-Synopsis.pdf&versionIdentifier=', 'label': 'CSR Synopsis add 1'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5164C00001&attachmentIdentifier=b88104d0-90ec-4a97-a0fe-f01222d612af&fileName=D5164C00001-CSR-addendum-2-Synopsis.pdf&versionIdentifier=', 'label': 'CSR Synopsis add 2'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy', 'detailedDescription': 'This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of AZD9291 versus placebo in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy. Adjuvant chemotherapy should have consisted of a platinum based doublet given for a maximum of 4 cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, aged at least 18 years.\n2. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology\n3. MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.\n4. Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.\n5. Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.\n6. Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.\n7. Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.\n8. World Health Organization Performance Status of 0 to 1.\n9. Female patients should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-child-bearing potential.\n\nExclusion Criteria:\n\n1. Treatment with any of the following:\n\n * Pre-operative or post-operative or planned radiation therapy for the current lung cancer\n * Pre-operative (neo-adjuvant) platinum based or other chemotherapy\n * Any prior anticancer therapy\n * Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time\n * Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug\n * Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4\n * Treatment with an investigational drug within five half-lives of the compound or any of its related material.\n2. Patients who have had only segmentectomies or wedge resections\n3. History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for \\> 5 years following the end of treatment.\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. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).\n6. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.\n7. Any of the following cardiac criteria:\n\n * Mean resting corrected QT interval (QTc) \\>470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.\n * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.\n * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.\n8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n9. Inadequate bone marrow reserve or organ function.'}, 'identificationModule': {'nctId': 'NCT02511106', 'acronym': 'ADAURA', 'briefTitle': 'AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).', 'orgStudyIdInfo': {'id': 'D5164C00001'}, 'secondaryIdInfos': [{'id': '2023-506524-82-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': '2015-000662-65', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD9291', 'description': 'AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.', 'interventionNames': ['Drug: AZD9291 80 mg/40 mg', 'Drug: Open-label AZD9291 80 mg/40 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo AZD9291', 'description': 'Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule.', 'interventionNames': ['Drug: Placebo AZD9291 80 mg/40 mg']}], 'interventions': [{'name': 'AZD9291 80 mg/40 mg', 'type': 'DRUG', 'description': 'The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily.', 'armGroupLabels': ['AZD9291']}, {'name': 'Placebo AZD9291 80 mg/40 mg', 'type': 'DRUG', 'description': 'The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily.', 'armGroupLabels': ['Placebo AZD9291']}, {'name': 'Open-label AZD9291 80 mg/40 mg', 'type': 'DRUG', 'description': 'Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy.', 'armGroupLabels': ['AZD9291']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.06387, 'lon': 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