Viewing Study NCT04533451

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Ignite Creation Date: 2025-12-24 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:44 PM
Study NCT ID: NCT04533451
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-06-13
First Post: 2020-08-19
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D015577', 'term': 'Geriatric Assessment'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jatoi.Aminah@mayo.edu', 'phone': '507-266-9160', 'title': 'Dr. Aminah Jatoi', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Group A (Pembrolizumab)', 'description': 'Quality-of-Life Assessment: Ancillary studies', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 43, 'seriousNumAtRisk': 43, 'deathsNumAffected': 8, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Group B (Pembrolizumab, Pemetrexed, Carboplatin)', 'description': 'Quality-of-Life Assessment: Ancillary studies', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 53, 'seriousNumAtRisk': 54, 'deathsNumAffected': 6, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 173, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 338, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Blood and lymph sys disorders - Oth Spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 39, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 13, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 12, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Ear and labyrinth disorders - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hypophysitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 87, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 71, 'numAffected': 15}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 24, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Flashing lights', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 22, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 23, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Belching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 94, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 175, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 35, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 58, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 14, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Gastrointestinal disorders - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 31, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 109, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Edema face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 30, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 215, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 376, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Gen disord and admin site conds-Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Generalized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 17, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 17, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 12, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hepatobiliary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Infections and infestations - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Bruising', 'stats': 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'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 21, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 31, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 26, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Dysuria (painful urination)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Renal and urinary disorders - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 15, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Urinary tract pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Urinary urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Vaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 215, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 207, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 199, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 228, 'numAffected': 40}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 23, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Postnasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Resp, thoracic, mediastinal - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Sinus pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 16, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Skin and subcut tissue disord - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 8, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 48, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 51, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}], 'seriousEvents': [{'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Neoplasms benign, mal, uncpec - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Grade 3 or Worse Adverse Events Post Registration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Pembrolizumab)', 'description': 'Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\\> \\>\\>\n\n\\>\n\n\\>\\> Pembrolizumab: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Comprehensive Geriatric Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Group B (Pembrolizumab, Pemetrexed, Carboplatin)', 'description': 'Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\\> \\>\\>\n\n\\>\n\n\\>\\> Pembrolizumab: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pemetrexed: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Carboplatin: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Comprehensive Geriatric Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days of last day of treatment, up to 6 months', 'description': 'Assessed by National Cancer Institute Common Terminology Criteria in Adverse Events version 5.0. The proportion of patients experience grade 3 or worse adverse events (AEs) will be summarized by frequency and percentage along with a 95% confidence interval (CI) separately by type of therapy (monotherapy or combination therapy) as well as combining the two cohorts. All other individual AEs will be analyzed in an exploratory and hypothesis generating manner; including and not limited to multi-variate logistic regression models considering the baseline demographics and the presence/absence of the AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A (Pembrolizumab)', 'description': 'Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\\> \\>\\>\n\n\\>\n\n\\>\\> Pembrolizumab: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Comprehensive Geriatric Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Group B (Pembrolizumab, Pemetrexed, Carboplatin)', 'description': 'Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\\> \\>\\>\n\n\\>\n\n\\>\\> Pembrolizumab: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pemetrexed: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Carboplatin: Given IV\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Comprehensive Geriatric Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'comment': 'Not enough events after median', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': 'NA'}, {'value': '29.9', 'comment': 'Not enough events after median', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0385', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From study registration to death or the last follow-up whichever occurs first, assessed up to 3 years', 'description': 'Will be summarized using the Kaplan-Meier estimator, separately by monotherapy or combination therapy as well as by the combined cohort.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QOL): Linear Analogue Self-Assessment [LASA] Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Arms', 'description': 'Arms A and arms B'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 9 weeks', 'description': 'The overall quality of life score (the first question of the Linear Analogue Self-Assessment \\[LASA\\] questionnaire) at each time point as well as change from baseline will be summarized by mean (standard deviation), median (range) along with a longitudinal plot. The median quality of life (QOL) change from baseline along with a 95% confidence interval (CI) will be estimated using the Hodges-Lehmann method. The overall quality of life score will be measured on a scale from 0-10, with higher being better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 60 patients who had QOL change from baseline to week 9. Per the protocol section 13.5, quality of life would be examined combined by arm.'}, {'type': 'SECONDARY', 'title': 'Comprehensive Geriatric Assessment Risk Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Group', 'description': 'Patients from both Arms A and arms B'}], 'classes': [{'title': 'Low Risk Group', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Medium Risk Group', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'High Risk Group', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.9829', 'groupIds': ['OG000'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Relatively large sample size and groups are independent.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline. Per the protocol section 13.5,Comprehensive geriatric assessment would be examined combined by arm.', 'description': 'The geriatric risk score, measured as low, medium, or high, will be summarized in a 3X2 frequency table with adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed with both arms combined'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A (Pembrolizumab)', 'description': 'Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\\>\\> \\>\\> Pembrolizumab: Given IV\\>\\>\n\n\\>\\> Comprehensive Geriatric Assessment: Ancillary studies\\>\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies'}, {'id': 'FG001', 'title': 'Group B (Pembrolizumab, Pemetrexed, Carboplatin)', 'description': 'Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\\>\\> \\>\\> Pembrolizumab: Given IV\\>\\>\n\n\\>\\> Pemetrexed: Given IV\\>\\>\n\n\\>\\> Carboplatin: Given IV\\>\\>\n\n\\>\\> Comprehensive Geriatric Assessment: Ancillary studies\\>\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A (Pembrolizumab)', 'description': 'Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\\>\\> \\>\\> Pembrolizumab: Given IV\\>\\>\n\n\\>\\> Comprehensive Geriatric Assessment: Ancillary studies\\>\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies'}, {'id': 'BG001', 'title': 'Group B (Pembrolizumab, Pemetrexed, Carboplatin)', 'description': 'Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\\>\\> \\>\\> Pembrolizumab: Given IV\\>\\>\n\n\\>\\> Pemetrexed: Given IV\\>\\>\n\n\\>\\> Carboplatin: Given IV\\>\\>\n\n\\>\\> Comprehensive Geriatric Assessment: Ancillary studies\\>\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'spread': '5.85', 'groupId': 'BG000'}, {'value': '76.1', 'spread': '4.21', 'groupId': 'BG001'}, {'value': '77.8', 'spread': '5.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction.\\> ECOG = 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.\\> ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.\\> ECOG = 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours.\\> ECOG = 0 is better. ECOG = 3 is worse.', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant Chemo', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Adjuvant Chemo', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Radiotherapy', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Any Prior Cancer Diagnosed', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Treatment started prior to enrollment', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking History', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PD-L1 Expression', 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '37.35', 'groupId': 'BG000'}, {'value': '13.6', 'spread': '25.84', 'groupId': 'BG001'}, {'value': '32.1', 'spread': '37.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Tumor Proportion Score (%)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diagnosis of Non-Small Cell Lung Cancer', 'classes': [{'title': 'Recurrent Metastatic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Stage IV', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-03', 'size': 1393126, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-17T17:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2020-08-19', 'resultsFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-24', 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Grade 3 or Worse Adverse Events Post Registration', 'timeFrame': 'Up to 7 days of last day of treatment, up to 6 months', 'description': 'Assessed by National Cancer Institute Common Terminology Criteria in Adverse Events version 5.0. The proportion of patients experience grade 3 or worse adverse events (AEs) will be summarized by frequency and percentage along with a 95% confidence interval (CI) separately by type of therapy (monotherapy or combination therapy) as well as combining the two cohorts. All other individual AEs will be analyzed in an exploratory and hypothesis generating manner; including and not limited to multi-variate logistic regression models considering the baseline demographics and the presence/absence of the AE.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From study registration to death or the last follow-up whichever occurs first, assessed up to 3 years', 'description': 'Will be summarized using the Kaplan-Meier estimator, separately by monotherapy or combination therapy as well as by the combined cohort.'}, {'measure': 'Quality of Life (QOL): Linear Analogue Self-Assessment [LASA] Questionnaire', 'timeFrame': 'Up to 9 weeks', 'description': 'The overall quality of life score (the first question of the Linear Analogue Self-Assessment \\[LASA\\] questionnaire) at each time point as well as change from baseline will be summarized by mean (standard deviation), median (range) along with a longitudinal plot. The median quality of life (QOL) change from baseline along with a 95% confidence interval (CI) will be estimated using the Hodges-Lehmann method. The overall quality of life score will be measured on a scale from 0-10, with higher being better.'}, {'measure': 'Comprehensive Geriatric Assessment Risk Score', 'timeFrame': 'At baseline. Per the protocol section 13.5,Comprehensive geriatric assessment would be examined combined by arm.', 'description': 'The geriatric risk score, measured as low, medium, or high, will be summarized in a 3X2 frequency table with adverse events.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Lung Adenocarcinoma', 'Metastatic Lung Non-Small Cell Carcinoma', 'Recurrent Lung Adenocarcinoma', 'Recurrent Lung Non-Small Cell Carcinoma', 'Stage IV Lung Cancer AJCC v8', 'Stage IVA Lung Cancer AJCC v8', 'Stage IVB Lung Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': "This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.", 'detailedDescription': 'The primary and secondary objectives of the study:\n\nPRIMARY OBJECTIVE:\n\nI. To estimate the adverse event profile of MK-3475 (pembrolizumab) in non-small cell lung cancer patients who are age 70 years of age or older and who are treated with MK-3475 (pembrolizumab) +/- chemotherapy in a first-line setting.\n\nSECONDARY OBJECTIVES:\n\nI. To estimate overall survival. II. To describe patient quality of life during the treatment using the Linear Analogue Self-Assessment (LASA) questionnaire.\n\nIII. To explore whether Comprehensive Geriatric Assessment (CGA) -derived risk score is able to predict rates of severe adverse events in older cancer patients who receive MK-3475 (pembrolizumab) or MK-3475 (pembrolizumab) + chemotherapy.\n\nOUTLINE: Patients are assigned to 1 of 2 groups.\n\nGROUP A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nGROUP B: Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up annually for up to 5 years after registration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documentation of Disease: Histologic or cytologic diagnosis of non-small cell lung cancer (adenocarcinoma). Stage IV or recurrent metastatic non-small cell lung cancer. No planned initiation of definitive (potentially curative) concurrent chemo-radiation\n* Planning to begin MK-3475 (pembrolizumab) treatment within 14 days of registration, with or without combination chemotherapy. Treating physician considers pembrolizumab as appropriate and plans to proceed with one of the following treatment schedules:\n\n * MK-3475 (pembrolizumab) 200 mg IV flat dose every 21 days or 400 mg IV every 42 days.\n * MK-3475 (pembrolizumab) 200 mg IV or 400 mg IV + carboplatin area under the curve (AUC) = 5 + pemetrexed 500 mg/m\\^2 (20% chemotherapy dose reduction is permitted per the discretion of the treating physician)\n* Patients will be ineligible if they have an autoimmune disorder, are post-organ transplantation, or are receiving ongoing immunosuppression treatment\n* Prior adjuvant therapy is allowed and must have been completed at least 6 months prior to registration\n* No planned radiation or other cancer treatment in the 3 months following registration\n* No untreated brain metastases. Patients must be off corticosteroids and asymptomatic at registration\n* Absolute neutrophil count (ANC) \\>= 1500/mm\\^3 (1.5 x 10\\^9/L)\n* Platelet count: \\>= 100,000/mm\\^3 (100 x 10\\^9/L)\n* Creatinine \\>= 30 mL/min\\* for patients enrolled to pembrolizumab alone and \\> 45 mL/min for patients enrolled to chemotherapy + pembrolizumab\n\n \\* Calculated using the Cockcroft-Gault formula\n* Total serum bilirubin =\\< 1.5 upper limit of normal (ULN) (\\< 3 ULN if Gilbert's disease)\n* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =\\< 3 x ULN (=\\< 5.0 x ULN if liver metastases present)\n* Alkaline phosphatase =\\< 2.5 x ULN (=\\< 5 x ULN if bone or liver metastases present) Language: Patients must be able to speak and comprehend English in order to complete the mandatory patient-completed measures"}, 'identificationModule': {'nctId': 'NCT04533451', 'briefTitle': 'Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': "Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated With First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice)", 'orgStudyIdInfo': {'id': 'A171901'}, 'secondaryIdInfos': [{'id': 'NCI-2020-00544', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Reporting Program'}, {'id': 'UG1CA189823', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA189823', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (pembrolizumab)', 'description': 'Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Pembrolizumab', 'Other: Comprehensive Geriatric Assessment', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (pembrolizumab, pemetrexed, carboplatin)', 'description': 'Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Pembrolizumab', 'Drug: Pemetrexed', 'Drug: Carboplatin', 'Other: Comprehensive Geriatric Assessment', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Group A (pembrolizumab)', 'Group B (pembrolizumab, pemetrexed, carboplatin)']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Group B (pembrolizumab, pemetrexed, carboplatin)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Group B (pembrolizumab, pemetrexed, carboplatin)']}, {'name': 'Comprehensive Geriatric Assessment', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group A (pembrolizumab)', 'Group B (pembrolizumab, pemetrexed, carboplatin)']}, {'name': 'Questionnaire 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