Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
Study NCT ID:
NCT02125461
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2014-04-25
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Brazil', 'Philippines', 'Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Results of interim PFS analysis are considered as final PFS analysis; results of interim OS analysis are considered as final OS analysis. Patients were followed up for long-term survival until approximately 5 years after last patient enrolled.'}}, 'adverseEventsModule': {'timeFrame': 'Serious and Other (non-serious) treatment-emergent adverse event (TEAE) data collected during the 12-month treatment period. All-cause mortality (death due to any cause) collected for entire duration of the study. Assessed until 11 Jan 2021 DCO for completion of long-term survival; approximately 5 years from last patient enrolled.', 'description': 'TEAEs included events from first dose of study drug until the earlier of 90 days after last dose or date of first subsequent therapy. 473 and 236 patients in the durvalumab and placebo groups, respectively, received treatment but 2 patients randomized to placebo received 1 dose of durvalumab in error and are included in the durvalumab safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.', 'otherNumAtRisk': 475, 'deathsNumAtRisk': 475, 'otherNumAffected': 436, 'seriousNumAtRisk': 475, 'deathsNumAffected': 262, 'seriousNumAffected': 138}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.', 'otherNumAtRisk': 234, 'deathsNumAtRisk': 234, 'otherNumAffected': 212, 'seriousNumAtRisk': 234, 'deathsNumAffected': 154, 'seriousNumAffected': 54}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 39, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 32, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 39, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 62, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 59, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 27, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 136, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 56, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 45, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 25, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 69, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 88, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 43, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 73, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 50, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 130, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 52, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 42, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 36, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 58, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 220, 'numAffected': 169}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 75, 'numAffected': 59}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 39, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 41, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 92, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 44, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 51, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 54, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Radiation pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 84, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 84, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 32, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 33, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 18, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 110, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 49, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 55, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 41, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 35, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 47, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 133, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 67, 'numAffected': 57}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 46, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 53, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 26, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 38, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 70, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 72, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Eosinophilic myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 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[{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Brain natriuretic peptide increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Iron overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Giant cell tumour of tendon sheath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Adjustment disorder with mixed anxiety and depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Glomerulonephritis membranous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Renal tubular acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Calculus prostatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acquired tracheo-oesophageal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '18.1'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '7.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.65', 'groupDescription': 'Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.', 'description': 'PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized patients, analyzed on an intent-to-treat (ITT) basis.'}, {'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper limit of 95% confidence interval (CI) could not be calculated as they were not reached.', 'groupId': 'OG000', 'lowerLimit': '34.7', 'upperLimit': 'NA'}, {'value': '28.7', 'comment': 'Upper limit of 95% CI could not be calculated as it was not reached.', 'groupId': 'OG001', 'lowerLimit': '22.9', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.00251', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.87', 'groupDescription': 'Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized patients, analyzed on an ITT basis.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '25.79', 'upperLimit': '34.53'}, {'value': '17.8', 'groupId': 'OG001', 'lowerLimit': '12.95', 'upperLimit': '23.65'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Analysis performed using Fisher's exact test with mid p-value modification by subtracting half of the probability of the observed table from Fisher's p-value.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \\>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (which included all randomized patients) with measureable disease at baseline, analyzed on an ITT basis.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and upper limit of 95% CI could not be calculated as they were not reached.', 'groupId': 'OG000', 'lowerLimit': '27.4', 'upperLimit': 'NA'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '24.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized patients, analyzed on an ITT basis. Only patients with an objective response were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'groupId': 'OG000', 'lowerLimit': '51.0', 'upperLimit': '60.4'}, {'value': '35.3', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '41.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.', 'description': 'APF12 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized patients, analyzed on an ITT basis.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000', 'lowerLimit': '37.7', 'upperLimit': '50.5'}, {'value': '27.0', 'groupId': 'OG001', 'lowerLimit': '19.9', 'upperLimit': '34.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.', 'description': 'APF18 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of PFS at 18 months.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized patients, analyzed on an ITT basis.'}, {'type': 'SECONDARY', 'title': 'Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '34.9'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '21.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.41', 'ciUpperLimit': '0.68', 'groupDescription': 'Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. TTDM was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized patients, analyzed on an ITT basis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Alive at 24 Months (OS24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000', 'lowerLimit': '61.7', 'upperLimit': '70.4'}, {'value': '55.6', 'groupId': 'OG001', 'lowerLimit': '48.9', 'upperLimit': '61.8'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value generated based on z-test where z-test statistic is the ratio of the log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by the square root of the variance.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "The variance was estimated using the delta method and Greenwood's formula."}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized patients, analyzed on an ITT basis.'}, {'type': 'SECONDARY', 'title': 'Time to Second Progression or Death (PFS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '34.7'}, {'value': '17.1', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '20.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.46', 'ciUpperLimit': '0.73', 'groupDescription': 'Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'PFS2 was defined as the time from randomization to the time of the second progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could have involved any of the following: objective radiological, symptomatic progression, or death. RECIST assessments were not collected for assessment of PFS2. PFS2 was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized patients, analyzed on an ITT basis.'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '9.3'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '10.5'}]}]}], 'analyses': [{'pValue': '0.664', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.18', 'pValueComment': 'Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.', 'groupDescription': 'The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'Global health status/HRQoL was assessed using the EORTC QLQ-C30 global QoL scale which includes 2 items from the QLQ-C30: "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall QoL during the past week?" (Item 30). Scores from 0 to 100 were derived for each item with higher scores indicating a better health status. Time to deterioration for global health status/HRQoL was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in global health status/HRQoL from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful deterioration. Time to deterioration was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized patients, analyzed on an ITT basis. Only patients with baseline scores ≥ 10 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'title': 'Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '3.7'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '4.1'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '7.3'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '6.0'}]}]}, {'title': 'Hemoptysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and 95% CIs could not be calculated as they were not reached.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '29.6', 'comment': 'Upper limit of 95% CI could not be calculated as it was not reached.', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': 'NA'}]}]}, {'title': 'Chest pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '18.6'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '13.8'}]}]}], 'analyses': [{'pValue': '0.522', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.29', 'pValueComment': 'Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.', 'groupDescription': 'Treatment comparison for dyspnea. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.380', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.12', 'pValueComment': 'Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.', 'groupDescription': 'Treatment comparison for cough. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.00', 'pValueComment': 'Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.', 'groupDescription': 'Treatment comparison for hemoptysis. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.626', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.19', 'pValueComment': 'Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.', 'groupDescription': 'Treatment comparison for chest pain. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized patients, analyzed on an ITT basis. Only patients with baseline scores ≤ 90 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '473', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}], 'classes': [{'title': 'Week 0: peak concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '191.00', 'spread': '72.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 8: trough concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '120.00', 'spread': '62.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: trough concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '177.00', 'spread': '47.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: peak concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '373.00', 'spread': '43.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 48: trough concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '186.00', 'spread': '67.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48, and post-dose on Day 1 (Week 0) and Week 24. Analysis performed at 22 Mar 2018 DCO.', 'description': 'To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion.', 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all patients who received at least 1 dose of durvalumab per the protocol, for whom any post-dose data were available, and who did not violate or deviate from the protocol in ways that would significantly affect the PK analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'classes': [{'title': 'ADA positive at any visit', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'ADA positive post-baseline only', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-boosted ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA positive at baseline and post-baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'ADA positive at baseline only', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ADA persistently positive', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'ADA transient positive', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neutralizing antibodies positive at any visit', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO.', 'description': 'ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADA evaluable population included patients who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '476'}, {'groupId': 'FG001', 'numSubjects': '237'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '476'}, {'groupId': 'FG001', 'numSubjects': '237'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '473'}, {'groupId': 'FG001', 'numSubjects': '236'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '475'}, {'groupId': 'FG001', 'numSubjects': '234'}]}, {'type': 'Completed 12 Months of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'comment': 'Ongoing study at final DCO (study complete)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '169'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'Missing Termination Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were randomized between 09 May 2014 and 22 Apr 2016 in 235 study centers across 26 countries. Data cut-off (DCO) date for analysis of progression-free survival (PFS) and PFS rates at 12 and 18 months: 13 Feb 2017; DCO date for analysis of overall survival (OS) and all other secondary outcome measures: 22 Mar 2018; DCO date for completion of long-term survival: 11 Jan 2021.', 'preAssignmentDetails': 'Eligible patients with locally advanced, unresectable Stage III non-small cell lung cancer were randomized in a 2:1 ratio to receive either durvalumab (MEDI4736) 10 milligrams (mg) / kilogram (kg) every 2 weeks (Q2W) or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '713', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Durvalumab (MEDI4736)', 'description': 'Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '8.66', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '9.64', 'groupId': 'BG001'}, {'value': '62.9', 'spread': '8.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '494', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking History', 'classes': [{'categories': [{'title': 'Non-smoker', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Ex-smoker', 'measurements': [{'value': '354', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '532', 'groupId': 'BG002'}]}, {'title': 'Current smoker', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis was based on the FAS consisting of all randomized patients.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-04', 'size': 9827797, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-20T04:59', 'hasProtocol': True}, {'date': '2017-03-22', 'size': 5537225, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-20T04:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 713}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2014-04-25', 'resultsFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2014-04-25', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-28', 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.', 'description': 'PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique.'}, {'measure': 'Overall Survival', 'timeFrame': 'From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \\>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.'}, {'measure': 'Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique.'}, {'measure': 'Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.', 'description': 'APF12 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months.'}, {'measure': 'Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.', 'description': 'APF18 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of PFS at 18 months.'}, {'measure': 'Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1', 'timeFrame': 'Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. TTDM was calculated using the Kaplan-Meier technique.'}, {'measure': 'Percentage of Patients Alive at 24 Months (OS24)', 'timeFrame': 'From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months.'}, {'measure': 'Time to Second Progression or Death (PFS2)', 'timeFrame': 'Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'PFS2 was defined as the time from randomization to the time of the second progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could have involved any of the following: objective radiological, symptomatic progression, or death. RECIST assessments were not collected for assessment of PFS2. PFS2 was calculated using the Kaplan-Meier technique.'}, {'measure': 'Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30)', 'timeFrame': 'At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'Global health status/HRQoL was assessed using the EORTC QLQ-C30 global QoL scale which includes 2 items from the QLQ-C30: "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall QoL during the past week?" (Item 30). Scores from 0 to 100 were derived for each item with higher scores indicating a better health status. Time to deterioration for global health status/HRQoL was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in global health status/HRQoL from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful deterioration. Time to deterioration was calculated using the Kaplan-Meier technique.'}, {'measure': 'Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13)', 'timeFrame': 'At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.', 'description': 'The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique.'}, {'measure': 'Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations', 'timeFrame': 'Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48, and post-dose on Day 1 (Week 0) and Week 24. Analysis performed at 22 Mar 2018 DCO.', 'description': 'To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion.'}, {'measure': 'Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab', 'timeFrame': 'Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO.', 'description': 'ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locally advanced', 'Unresectable Non-Small Cell Lung Cancer', 'MEDI4736', 'PD-L1', 'Stage III Non-Small Cell Lung Cancer', 'Chemoradiation', 'Immune-mediated cancer therapy'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '36841540', 'type': 'DERIVED', 'citation': 'Naidoo J, Antonia S, Wu YL, Cho BC, Thiyagarajah P, Mann H, Newton M, Faivre-Finn C. Brief Report: Durvalumab After Chemoradiotherapy in Unresectable Stage III EGFR-Mutant NSCLC: A Post Hoc Subgroup Analysis From PACIFIC. J Thorac Oncol. 2023 May;18(5):657-663. doi: 10.1016/j.jtho.2023.02.009. Epub 2023 Feb 24.'}, {'pmid': '35247871', 'type': 'DERIVED', 'citation': 'Senan S, Ozguroglu M, Daniel D, Villegas A, Vicente D, Murakami S, Hui R, Faivre-Finn C, Paz-Ares L, Wu YL, Mann H, Dennis PA, Antonia SJ. Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial. ESMO Open. 2022 Apr;7(2):100410. doi: 10.1016/j.esmoop.2022.100410. Epub 2022 Mar 2.'}, {'pmid': '35245844', 'type': 'DERIVED', 'citation': 'Naidoo J, Vansteenkiste JF, Faivre-Finn C, Ozguroglu M, Murakami S, Hui R, Quantin X, Broadhurst H, Newton M, Thiyagarajah P, Antonia SJ. Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. Lung Cancer. 2022 Apr;166:84-93. doi: 10.1016/j.lungcan.2022.02.003. Epub 2022 Feb 9.'}, {'pmid': '35108059', 'type': 'DERIVED', 'citation': 'Spigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, Vansteenkiste JF, Garassino MC, Hui R, Quantin X, Rimner A, Wu YL, Ozguroglu M, Lee KH, Kato T, de Wit M, Kurata T, Reck M, Cho BC, Senan S, Naidoo J, Mann H, Newton M, Thiyagarajah P, Antonia SJ. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Apr 20;40(12):1301-1311. doi: 10.1200/JCO.21.01308. Epub 2022 Feb 2.'}, {'pmid': '34484473', 'type': 'DERIVED', 'citation': 'Ouwens M, Darilay A, Zhang Y, Mukhopadhyay P, Mann H, Ryan J, Dennis PA. Assessing the Influence of Subsequent Immunotherapy on Overall Survival in Patients with Unresectable Stage III Non-Small Cell Lung Cancer from the PACIFIC Study. 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Epub 2021 Jan 19.'}, {'pmid': '33285469', 'type': 'DERIVED', 'citation': 'Faivre-Finn C, Spigel DR, Senan S, Langer C, Perez BA, Ozguroglu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Paz-Ares L, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ. Impact of prior chemoradiotherapy-related variables on outcomes with durvalumab in unresectable Stage III NSCLC (PACIFIC). Lung Cancer. 2021 Jan;151:30-38. doi: 10.1016/j.lungcan.2020.11.024. Epub 2020 Nov 26.'}, {'pmid': '32209338', 'type': 'DERIVED', 'citation': 'Paz-Ares L, Spira A, Raben D, Planchard D, Cho BC, Ozguroglu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Spigel D, Senan S, Langer CJ, Perez BA, Boothman AM, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ, Faivre-Finn C. Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial. Ann Oncol. 2020 Jun;31(6):798-806. doi: 10.1016/j.annonc.2020.03.287. Epub 2020 Mar 21.'}, {'pmid': '31622733', 'type': 'DERIVED', 'citation': 'Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, Cho BC, Planchard D, Paz-Ares L, Faivre-Finn C, Vansteenkiste JF, Spigel DR, Wadsworth C, Taboada M, Dennis PA, Ozguroglu M, Antonia SJ. Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC. J Thorac Oncol. 2020 Feb;15(2):288-293. doi: 10.1016/j.jtho.2019.10.002. Epub 2019 Oct 14.'}, {'pmid': '31601496', 'type': 'DERIVED', 'citation': 'Hui R, Ozguroglu M, Villegas A, Daniel D, Vicente D, Murakami S, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Gray JE, Ryden A, Viviers L, Poole L, Zhang Y, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study. Lancet Oncol. 2019 Dec;20(12):1670-1680. doi: 10.1016/S1470-2045(19)30519-4. Epub 2019 Oct 7.'}, {'pmid': '30280658', 'type': 'DERIVED', 'citation': 'Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.'}, {'pmid': '28885881', 'type': 'DERIVED', 'citation': 'Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.'}], 'seeAlsoLinks': [{'url': 'http://www.emergingmed.com/networks/AstraZeneca', 'label': 'AstraZeneca Cancer Study Locator Service astrazeneca@emergingmed.com 1-877-400-465'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D4191C00001&attachmentIdentifier=5253288a-15c6-48e2-a5b4-20315b70234e&fileName=D4191C00001-CSR_synopsis_redacted.pdf&versionIdentifier=', 'label': 'CSR redacted synopsis'}]}, 'descriptionModule': {'briefSummary': 'A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.', 'detailedDescription': 'A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age at least 18 years.\n2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III)\n3. Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.\n4. World Health Organisation (WHO) Performance Status of 0 to 1.\n5. Estimated life expectancy of more than 12 weeks.\n\nExclusion Criteria:\n\n1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.\n2. Active or prior autoimmune disease or history of immunodeficiency.\n3. Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.\n4. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.\n5. Any unresolved toxicity CTCAE \\>Grade 2 from the prior chemoradiation therapy.\n6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)."}, 'identificationModule': {'nctId': 'NCT02125461', 'acronym': 'PACIFIC', 'briefTitle': 'A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)', 'orgStudyIdInfo': {'id': 'D4191C00001'}, 'secondaryIdInfos': [{'id': '2014-000336-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI4736', 'description': 'MEDI4736 (intravenous infusion)', 'interventionNames': ['Drug: MEDI4736']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'description': 'Placebo (matching placebo for intravenous infusion)', 'interventionNames': ['Other: PLACEBO']}], 'interventions': [{'name': 'MEDI4736', 'type': 'DRUG', 'description': 'MEDI4736 by intravenous infusion. 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