Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
Study NCT ID:
NCT03382561
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2017-12-21
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C044245', 'term': '1,2-diaminocyclohexaneplatinum II citrate'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eatrials@jimmy.harvard.edu', 'phone': '617-632-3012', 'title': 'Study Statistician', 'organization': 'ECOG-ACRIN Statistical Office'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Assessed every 6 weeks while on treatment and for 30 days after the end of treatment for adverse events. All-cause mortality was assessed up to 4 years.', 'description': 'All patients were included in the all-cause mortality analysis. Only patients who received treatment were included in the analysis of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)', 'description': 'Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 80, 'otherNumAffected': 76, 'seriousNumAtRisk': 77, 'deathsNumAffected': 67, 'seriousNumAffected': 59}, {'id': 'EG001', 'title': 'Arm B (Cisplatin/Carboplatin and Etoposide; CE)', 'description': 'Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 80, 'otherNumAffected': 73, 'seriousNumAtRisk': 74, 'deathsNumAffected': 74, 'seriousNumAffected': 49}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 57}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 30}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Investigations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}], 'seriousEvents': [{'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Bullous dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Skin and subcutaneous tissue disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Endocrine disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Upper gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Immune system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 38}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Serum amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Investigations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Metabolism and nutrition disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)', 'description': 'Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Arm B (Cisplatin/Carboplatin and Etoposide; CE)', 'description': 'Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '5.9'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '5.7'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.11', 'estimateComment': 'Hazard ratio: Arm A (CEN)/Arm B (CE)', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months', 'description': 'PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced an event of interest by the time of analysis will be censored at the date they are last known to be alive and progression-free.\n\nProgression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression was defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and treated patients were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)', 'description': 'Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Arm B (Cisplatin/Carboplatin and Etoposide; CE)', 'description': 'Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '14.2'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '9.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until off treatment or end of observation. Then every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months.', 'description': 'OS is defined as the time from maintenance randomization until death of any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and treated patients were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)', 'description': 'Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.'}, {'id': 'OG001', 'title': 'Arm B (Cisplatin/Carboplatin and Etoposide; CE)', 'description': 'Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '0.86'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.68', 'upperLimit': '0.88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months', 'description': 'Best overall response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response was defined as complete response (CR) or partial response (PR).\n\nCR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible and treated patients were included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'PD-L1 Expression Level', 'timeFrame': 'Assessed at baseline and 6 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Association Between Circulating Tumor DNA and Clinical Outcome', 'timeFrame': 'circulating tumor DNA was assessed at baseline and 6 weeks; clinical outcomes were assessed every 3 months for patients < 2 years from registration, every 6 months if patient is 2-3 years from registration, and annually until 5 years from registration', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)', 'description': 'Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.'}, {'id': 'FG001', 'title': 'Arm B (Cisplatin/Carboplatin and Etoposide; CE)', 'description': 'Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'Eligible and Treated Patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Alternative therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Never started treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other complicating disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study activated on May 2, 2018, and closed to accrual on December 7, 2018 after enrolling a total of 160 patients.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)', 'description': 'Patients receive nivolumab IV at 360 mg over 30 minutes on day 1, carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.'}, {'id': 'BG001', 'title': 'Arm B (Cisplatin/Carboplatin and Etoposide; CE)', 'description': 'Patients receive carboplatin AUC 5 or 6 IV over 30-60 minutes on day 1 or cisplatin at 75 mg/m2 IV over 60-120 minutes on day 1, and etoposide at 100 mg/m2 IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '85'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '43', 'upperLimit': '86'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '43', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': '2', 'groupId': 'BG001'}, {'value': '2', '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': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '149', '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': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized patients'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-17', 'size': 2463320, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-29T11:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2017-12-21', 'resultsFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-31', 'studyFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PD-L1 Expression Level', 'timeFrame': 'Assessed at baseline and 6 weeks'}, {'measure': 'Association Between Circulating Tumor DNA and Clinical Outcome', 'timeFrame': 'circulating tumor DNA was assessed at baseline and 6 weeks; clinical outcomes were assessed every 3 months for patients < 2 years from registration, every 6 months if patient is 2-3 years from registration, and annually until 5 years from registration'}], 'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months', 'description': 'PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced an event of interest by the time of analysis will be censored at the date they are last known to be alive and progression-free.\n\nProgression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression was defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until off treatment or end of observation. Then every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months.', 'description': 'OS is defined as the time from maintenance randomization until death of any cause.'}, {'measure': 'Response Rate', 'timeFrame': 'Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months', 'description': 'Best overall response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response was defined as complete response (CR) or partial response (PR).\n\nCR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extensive Stage Lung Small Cell Carcinoma', 'Recurrent Lung Small Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '33509647', 'type': 'DERIVED', 'citation': 'Wu J, Zhang A, Li L, Liu S, Yang F, Yang R. Meta-analysis of the Efficacy and Tolerability of Immune Checkpoint Inhibitors Combined With Chemotherapy in First-line Treatment of Small Cell Lung Cancer. Clin Ther. 2021 Mar;43(3):582-593.e2. doi: 10.1016/j.clinthera.2020.12.017. Epub 2021 Jan 25.'}]}, 'descriptionModule': {'briefSummary': "This randomized phase II clinical trial studies whether the addition of nivolumab to cisplatin (or carboplatin) and etoposide will improve outcomes when treating patients with extensive stage small cell lung cancer. Chemotherapy drugs, such as cisplatin, carboplatin, and etoposide, 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cisplatin/carboplatin and etoposide together with nivolumab may work better in treating patients with extensive stage small cell lung cancer.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the progression-free survival (PFS) of patients with extensive stage small cell lung cancer (ED-SCLC) treated with cisplatin/carboplatin and etoposide (CE) or CE with nivolumab (CEN) as front-line treatment.\n\nSECONDARY OBJECTIVES:\n\nI. To estimate overall survival of patients with ED-SCLC treated with cisplatin/carboplatin and etoposide (CE) or CE with nivolumab (CEN) as front-line treatment.\n\nII. To assess best overall response rate after treatment with CE with or without nivolumab as first line treatment.\n\nIII. To evaluate the toxicity profile of nivolumab with CE.\n\nEXPLORATORY OBJECTIVES:\n\nI. To evaluate immune biomarkers and biomarkers correlatives. II. To evaluate serial circulating tumor deoxyribonucleic acid (DNA) and explore whether clinical outcome is associated with fluctuations in DNA levels following the administration of therapy.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1, carboplatin IV over 30-60 minutes on day 1 or cisplatin IV over 60-120 minutes on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.\n\nARM B: Patients receive carboplatin IV over 30-60 minutes on day 1 or cisplatin IV over 60-120 minutes on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months if the patient is less than 2 years from registration, every 6 months if the patient is 2-3 years from registration, and yearly for up to 5 years from study enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed extensive stage small cell lung cancer and must be a candidate for systemic therapy; NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy; patients with locally recurrent SCLC who are not eligible for curative intent chemoradiation are eligible\n* Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Absolute neutrophil count \\>= 1,500/mm\\^3 (must be obtained =\\< 7 days prior to protocol registration)\n* Platelets \\>= 100,000/mm\\^3 (must be obtained =\\< 7 days prior to protocol registration)\n* Leukocytes \\>= 3000/mm\\^3 (must be obtained =\\< 7 days prior to protocol registration)\n* Hemoglobin \\>= 9 g/dL (must be obtained =\\< 7 days prior to protocol registration)\n* Total bilirubin =\\< 1.5 x institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin \\< 3 mg/dL) (must be obtained =\\< 7 days prior to protocol registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\< 3 X institutional upper limit of normal (ULN) (=\\< 5 X if liver function test \\[LFT\\] elevations due to known liver metastases) (must be obtained =\\< 7 days prior to protocol registration)\n* Serum creatinine =\\< 1.5 x ULN or calculated creatinine clearance \\> 50 mL/min (using the Cockcroft-Gault formula) (must be obtained =\\< 7 days prior to protocol registration)\n* Patients are eligible if central nervous system (CNS) metastases are adequately treated and neurological symptoms have returned to baseline or are controlled for at least 2 weeks prior to enrollment; in addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of =\\< 10 mg daily prednisone (or equivalent); patients with untreated CNS metastases are eligible if they are not symptomatic and the lesions are less than 1 cm in size\n* Patients cannot have had prior chemotherapy or biologic therapy for extensive stage small cell lung cancer for front line treatment; patients receiving prior whole brain radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to =\\< grade 1; a 1-week washout is permitted for palliative radiation (=\\< 2 weeks of radiotherapy) to non-CNS disease\n* Patients who have received prior chemoradiation treatment with chemotherapy regimen including cisplatin or carboplatin/etoposide for limited-stage SCLC are eligible if treated with curative intent at least 6 months since last treatment from diagnosis of extensive-stage SCLC\n* Patients may not be receiving any other investigational agents while on study\n* Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment for women of childbearing potential and 7 months after the last dose of protocol treatment for males who are sexually active with WOCBP\n* No prior or current invasive malignancy (except non-melanomatous skin cancer, localized bladder and prostate cancer) unless disease free for a minimum of 2 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);\n* No prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways;\n* No patients with an active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes including but not limited to myasthenia gravis, Lambert-Eaton myasthenic syndrome, limbic encephalitis, myositis, Guillain-Barre; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* No patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 7 days of randomization; inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* No patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity\n* No history of severe hypersensitivity reaction to any monoclonal antibody or allergy to study drug components\n\nExclusion Criteria:\n\n* Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab or other agents used in the study\n* Women must not be pregnant or breast-feeding; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents used in this study, breastfeeding must be discontinued or the subject is not eligible for the study; all females of childbearing potential must have a blood test or urine study, with a minimum sensitivity 50 mlU/L or equivalent units of human chorionic gonadotropin (HCG), within 14 days prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months)\n* Patient must not have leptomeningeal disease\n* Patients must NOT have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible\n* Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, patients are excluded\n* Patients are ineligible if they received a live, attenuated vaccine within 4 weeks before randomization'}, 'identificationModule': {'nctId': 'NCT03382561', 'briefTitle': 'Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomized Phase II Clinical Trial of Cisplatin/Carboplatin and Etoposide (CE) Alone or in Combination With Nivolumab as Frontline Therapy for Extensive Stage Small Cell Lung Cancer (ED-SCLC)', 'orgStudyIdInfo': {'id': 'NCI-2017-02367'}, 'secondaryIdInfos': [{'id': 'NCI-2017-02367', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'EA5161', 'type': 'OTHER', 'domain': 'ECOG-ACRIN Cancer Research Group'}, {'id': 'EA5161', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180820', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180820', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (nivolumab, CE)', 'description': 'Patients receive nivolumab IV over 30 minutes on day 1, carboplatin IV over 30-60 minutes on day 1 or cisplatin IV over 60-120 minutes on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Etoposide', 'Biological: Nivolumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B (CE)', 'description': 'Patients receive carboplatin IV over 30-60 minutes on day 1 or cisplatin IV over 60-120 minutes on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Etoposide']}], 'interventions': [{'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Blastocarb', 'Carboplat', 'Carboplatin Hexal', 'Carboplatino', 'Carboplatinum', 'Carbosin', 'Carbosol', 'Carbotec', 'CBDCA', 'Displata', 'Ercar', 'JM-8', 'JM8', 'Nealorin', 'Novoplatinum', 'Paraplatin', 'Paraplatin AQ', 'Paraplatine', 'Platinwas', 'Ribocarbo'], 'description': 'Given IV', 'armGroupLabels': ['Arm A (nivolumab, CE)', 'Arm B (CE)']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Abiplatin', 'Blastolem', 'Briplatin', 'CDDP', 'Cis-diammine-dichloroplatinum', 'Cis-diamminedichloridoplatinum', 'Cis-diamminedichloro Platinum (II)', 'Cis-diamminedichloroplatinum', 'Cis-dichloroammine Platinum (II)', 'Cis-platinous Diamine Dichloride', 'Cis-platinum', 'Cis-platinum II', 'Cis-platinum II Diamine 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