Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 7:13 PM
Study NCT ID:
NCT05089734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-23
First Post:
2021-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608132', 'term': 'sacituzumab govitecan'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality and Adverse Events: Up to 24.4 months', 'description': 'Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment assignments designated according to the actual treatment received.; All-Cause Mortality: The ITT Analysis Set included all randomized participants according to the treatment arm to which the participant was randomized.', 'eventGroups': [{'id': 'EG000', 'title': 'Sacituzumab Govitecan (SG)', 'description': 'Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).', 'otherNumAtRisk': 296, 'deathsNumAtRisk': 299, 'otherNumAffected': 283, 'seriousNumAtRisk': 296, 'deathsNumAffected': 168, 'seriousNumAffected': 137}, {'id': 'EG001', 'title': 'Docetaxel', 'description': 'Participants received docetaxel 75 mg/m\\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).', 'otherNumAtRisk': 288, 'deathsNumAtRisk': 304, 'otherNumAffected': 267, 'seriousNumAtRisk': 288, 'deathsNumAffected': 187, 'seriousNumAffected': 124}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 88}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 62}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 116}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 155}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 97}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 75}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 167}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 160}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 69}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 45}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 47}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 86}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Motor dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Bronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Bronchostenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Interstitial lung abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Pulmonary toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Respiratory tract ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacituzumab Govitecan (SG)', 'description': 'Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received docetaxel 75 mg/m\\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '12.3'}, {'value': '9.8', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '10.6'}]}]}], 'analyses': [{'pValue': '0.0534', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.04', 'pValueComment': 'Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24.4 months', 'description': 'OS is defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent to Treat (ITT) Analysis Set included all randomized participants according to the treatment arm to which the participant was randomized.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacituzumab Govitecan (SG)', 'description': 'Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received docetaxel 75 mg/m\\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '4.4'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '4.2'}]}]}], 'analyses': [{'pValue': '0.1938', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.11', 'pValueComment': 'Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24.4 months', 'description': 'PFS is defined as the time from the date of randomization until the date of objective disease progression (PD) or death from any cause, whichever occurs first as assessed by RECIST v.1.1. As per RECIST 1.1, PD was defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was 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 or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Participants who did not have documented disease progression and did not die were censored at their last tumor assessment date. Kaplan-Meier estimate was used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacituzumab Govitecan (SG)', 'description': 'Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received docetaxel 75 mg/m\\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '18.1'}, {'value': '18.1', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '22.9'}]}]}], 'analyses': [{'pValue': '0.9255', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.3', 'ciLowerLimit': '-10.1', 'ciUpperLimit': '1.5', 'pValueComment': 'The 1-sided p-value is calculated using Cochran Mantel-Haenszel test adjusted for randomization stratification factors of histology, and best response to last prior immune therapy received.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24.4 months', 'description': 'ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) that was confirmed at least 4 weeks later as assessed by RECIST v.1.1. As per RECIST 1.1 CR was defined as: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was defined as: At least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacituzumab Govitecan (SG)', 'description': 'Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received docetaxel 75 mg/m\\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '9.8'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '8.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24.4 months', 'description': 'DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by RECIST v. 1.1. As per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, and PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was 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 or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Kaplan-Meier estimate was used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT Population who achieved confirmed complete or partial response were analyzed.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacituzumab Govitecan (SG)', 'description': 'Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received docetaxel 75 mg/m\\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '61.9', 'upperLimit': '72.8'}, {'value': '67.1', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '72.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24.4 months', 'description': 'DCR was defined as the percentage of participants who achieved a CR, PR,or stable disease(SD)as assessed by RECIST v.1.1. Per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum LD since the treatment started and persistence of 1 or more nontarget lesion(s).PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study),in addition of increase of 20% sum also demonstrate an absolute increase of at least 5 mm or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 3.5 years', 'description': "An AE was defined as any untoward medical occurrence in a participants administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-05'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Post-Baseline', 'timeFrame': 'Up to 3.5 years', 'description': "Blood samples were collected for hematology, serum chemistry, and the laboratory abnormalities were assessed. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days.The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 will be reported.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-05'}, {'type': 'SECONDARY', 'title': 'Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacituzumab Govitecan (SG)', 'description': 'Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received docetaxel 75 mg/m\\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '4.0'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.9'}]}]}], 'analyses': [{'pValue': '0.0020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.91', 'pValueComment': 'Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24.4 months', 'description': 'The NSCLC-SAQ is a participant reported outcome with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No \\<symptom\\> At All" to "Very severe \\<symptom\\>" or from "Never to Always" depending on the item\'s question structure relative to either intensity or frequency, corresponding to a score of 0 to 4, with total score ranging from 0 to 20. The dyspnea (shortness of breath) item uses a "Never(0) to Always(4)" rating scale with higher score indicating higher frequency of dyspnea. Time to deterioration (TTD) was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For shortness of breath domain, a 1-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to First Deterioration in NSCLC-SAQ Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sacituzumab Govitecan (SG)', 'description': 'Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants received docetaxel 75 mg/m\\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '3.9'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.5'}]}]}], 'analyses': [{'pValue': '0.0125', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.97', 'pValueComment': 'Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24.4 months', 'description': 'The NSCLC-SAQ is a participant reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No \\<symptom\\> At All" to "Very severe \\<symptom\\>" or from "Never to Always" depending on the item\'s question structure relative to either intensity or frequency, corresponding to a score of 0 to 4. A total score sums all five domain scores at each visit. If any domain score was missing, the score was not computed. The total score ranges between 0 and 20, with higher scores indicating more severe symptoms. TTD was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For NSCLC-SAQ total score, a 2-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT Analysis Set were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sacituzumab Govitecan (SG)', 'description': 'Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).'}, {'id': 'FG001', 'title': 'Docetaxel', 'description': 'Participants received docetaxel 75 mg/m\\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '304'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '304'}]}], 'dropWithdraws': [{'type': 'Still on study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in Europe, North America, Brazil, Israel, Japan, Turkey, Australia, and Puerto Rico.', 'preAssignmentDetails': '784 participants were screened. Data submitted represent interim analysis performed on data collected by the Primary Completion Date. Complete data will be submitted in May 2026.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '603', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sacituzumab Govitecan (SG)', 'description': 'Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months).'}, {'id': 'BG001', 'title': 'Docetaxel', 'description': 'Participants received docetaxel 75 mg/m\\^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months).'}, {'id': 'BG002', 'title': 'Total~(N=584)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '64', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '64', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'Between 18 and 65 years', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '410', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '534', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent to Treat (ITT) Analysis Set included all randomized participants according to the treatment arm to which the participant was randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-22', 'size': 1542433, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-31T13:59', 'hasProtocol': True}, {'date': '2023-07-12', 'size': 1594286, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-22T09:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 603}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2021-10-11', 'resultsFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-13', 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 24.4 months', 'description': 'OS is defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1', 'timeFrame': 'Up to 24.4 months', 'description': 'PFS is defined as the time from the date of randomization until the date of objective disease progression (PD) or death from any cause, whichever occurs first as assessed by RECIST v.1.1. As per RECIST 1.1, PD was defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was 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 or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Participants who did not have documented disease progression and did not die were censored at their last tumor assessment date. Kaplan-Meier estimate was used for analysis.'}, {'measure': 'Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1', 'timeFrame': 'Up to 24.4 months', 'description': 'ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) that was confirmed at least 4 weeks later as assessed by RECIST v.1.1. As per RECIST 1.1 CR was defined as: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was defined as: At least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.'}, {'measure': 'Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1', 'timeFrame': 'Up to 24.4 months', 'description': 'DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by RECIST v. 1.1. As per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, and PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was 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 or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Kaplan-Meier estimate was used for analysis.'}, {'measure': 'Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1', 'timeFrame': 'Up to 24.4 months', 'description': 'DCR was defined as the percentage of participants who achieved a CR, PR,or stable disease(SD)as assessed by RECIST v.1.1. Per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum LD since the treatment started and persistence of 1 or more nontarget lesion(s).PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study),in addition of increase of 20% sum also demonstrate an absolute increase of at least 5 mm or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.'}, {'measure': 'Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 3.5 years', 'description': "An AE was defined as any untoward medical occurrence in a participants administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0."}, {'measure': 'Percentage of Participants Who Experienced Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Post-Baseline', 'timeFrame': 'Up to 3.5 years', 'description': "Blood samples were collected for hematology, serum chemistry, and the laboratory abnormalities were assessed. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days.The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 will be reported."}, {'measure': 'Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)', 'timeFrame': 'Up to 24.4 months', 'description': 'The NSCLC-SAQ is a participant reported outcome with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No \\<symptom\\> At All" to "Very severe \\<symptom\\>" or from "Never to Always" depending on the item\'s question structure relative to either intensity or frequency, corresponding to a score of 0 to 4, with total score ranging from 0 to 20. The dyspnea (shortness of breath) item uses a "Never(0) to Always(4)" rating scale with higher score indicating higher frequency of dyspnea. Time to deterioration (TTD) was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For shortness of breath domain, a 1-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis.'}, {'measure': 'Time to First Deterioration in NSCLC-SAQ Total Score', 'timeFrame': 'Up to 24.4 months', 'description': 'The NSCLC-SAQ is a participant reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No \\<symptom\\> At All" to "Very severe \\<symptom\\>" or from "Never to Always" depending on the item\'s question structure relative to either intensity or frequency, corresponding to a score of 0 to 4. A total score sums all five domain scores at each visit. If any domain score was missing, the score was not computed. The total score ranges between 0 and 20, with higher scores indicating more severe symptoms. TTD was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For NSCLC-SAQ total score, a 2-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '38843511', 'type': 'DERIVED', 'citation': 'Paz-Ares LG, Juan-Vidal O, Mountzios GS, Felip E, Reinmuth N, de Marinis F, Girard N, Patel VM, Takahama T, Owen SP, Reznick DM, Badin FB, Cicin I, Mekan S, Patel R, Zhang E, Karumanchi D, Garassino MC. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733. Epub 2024 May 31.'}], 'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=GS-US-577-6153', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).\n* Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are required. Testing prior to enrollment. Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For patients with squamous cell carcinoma, EGFR and ALK testing is optional.\n* Must have progressed after platinum-based chemotherapy in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially.\n\n * No additional treatments are allowed in the recurrent/metastatic setting for individuals with no actionable genomic alterations.\n * Individuals with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 locally approved and available tyrosine kinase inhibitor 1(TKI) appropriate to the genomic alteration.\n * Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.\n* Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in accordance with per RECIST Version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before randomization.\n* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count ≥ 1500/mm\\^3, and platelets ≥ 100,000/μL).\n* Adequate hepatic function (bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤ 2.5 ULN or ≤ 5 x ULN if known liver metastases, and serum albumin \\> 3 g/dL).\n* Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation.\n* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.\n\nKey Exclusion Criteria:\n\n* Mixed small-cell lung cancer and NSCLC histology.\n* Positive serum pregnancy test or women who are lactating.\n* Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, \\> Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.\n* Have not recovered (ie, \\> Grade 2 is considered not recovered) from AEs due to a previously administered agent.\n* Previously received treatment with any of the following:\n\n * Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase 1\n * Trop-2-targeted therapy\n * Docetaxel as monotherapy or in combination with other agents\n* Active second malignancy\n* NSCLC that is eligible for definitive local therapy alone.\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy.\n* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Active cardiac disease\n* Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.\n* Active serious infection requiring antibiotics.\n* Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism.\n* Positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease.\n* Positive hepatitis C antibody and detectable hepatitis C viral load.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT05089734', 'acronym': 'EVOKE-01', 'briefTitle': 'Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy', 'orgStudyIdInfo': {'id': 'GS-US-577-6153'}, 'secondaryIdInfos': [{'id': 'jRCT2051220119', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials'}, {'id': '2024-512148-50', 'type': 'OTHER', 'domain': 'European Medicines Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sacituzumab Govitecan-hziy (SG)', 'description': 'Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.', 'interventionNames': ['Biological: Sacituzumab Govitecan-hziy (SG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Docetaxel', 'description': 'Participants will receive docetaxel 75 mg/m\\^2 on Day 1 of a 21-day cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.', 'interventionNames': ['Drug: Docetaxel']}], 'interventions': [{'name': 'Sacituzumab Govitecan-hziy (SG)', 'type': 'BIOLOGICAL', 'otherNames': ['IMMU-132', 'GS-0132'], 'description': 'Administered intravenously', 'armGroupLabels': ['Sacituzumab Govitecan-hziy (SG)']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Oncology and Hematology, LLC.', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'USOR - Arizona Oncology Associates Tucson - Wilmot', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Beverly Hills Cancer Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers - Aurora', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists (Administration and Drug Shipment)', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32503', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Woodlands Medical Specialists, PA', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Cancer Specialists', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Regional Cancer Center dba June E. 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{'zip': '75020', 'city': 'Denison', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Denison', 'geoPoint': {'lat': 33.75566, 'lon': -96.53666}}, {'zip': '76201', 'city': 'Denton', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Denton South', 'geoPoint': {'lat': 33.21484, 'lon': -97.13307}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology Cancer Care and Research Center', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '75071', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'USOR - Texas Oncology - McKinney', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '75460', 'city': 'Paris', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Paris', 'geoPoint': {'lat': 33.66094, 'lon': -95.55551}}, {'zip': '75075', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas 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