Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT04685135
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-22
First Post:
2020-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718190', 'term': 'adagrasib'}, {'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': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All cause mortality and non serious adverse events were reported from first first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks). Serious adverse events were collected from date of signing of informed consent form till 28 days after last dose (Up to approximately 111 weeks).', 'description': 'The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).', 'otherNumAtRisk': 298, 'deathsNumAtRisk': 301, 'otherNumAffected': 292, 'seriousNumAtRisk': 298, 'deathsNumAffected': 126, 'seriousNumAffected': 149}, {'id': 'EG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 152, 'otherNumAffected': 129, 'seriousNumAtRisk': 140, 'deathsNumAffected': 53, 'seriousNumAffected': 50}, {'id': 'EG002', 'title': 'Crossover Adagrasib', 'description': 'Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID).', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 43, 'seriousNumAtRisk': 44, 'deathsNumAffected': 15, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 169}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Subarachnoid 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'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Glomerulonephritis membranoproliferative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hypersensitivity pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) as Per Blinded Independent Central Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.49', 'groupId': 'OG000', 'lowerLimit': '4.53', 'upperLimit': '6.67'}, {'value': '3.84', 'groupId': 'OG001', 'lowerLimit': '2.73', 'upperLimit': '4.73'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.76', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'HR and CI are from stratified Cox proportional hazard model'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)', 'description': 'Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of 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': 'Intent-To-Treat Population includes all participants who are randomized into this study.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'timeFrame': 'From randomization till death due to any cause (up to approximately 143 weeks)', 'description': 'Overall survival is defined as the time from randomization to the date of death due to any cause.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) as Per Blinded Independent Central Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000', 'lowerLimit': '26.7', 'upperLimit': '37.5'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '15.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.68', 'ciLowerLimit': '2.56', 'ciUpperLimit': '8.56', 'statisticalMethod': 'Cochran Mantel Haenszel chi-square test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization till death or till disease progression or initiation of follow-up anti-cancer therapy or withdrawal of consent prior to minimum efficacy follow-up (up to 143 weeks)', 'description': 'Objective Response Rate (ORR) is defined as the percent of participants documented to have a confirmed complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \\< 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Population includes all participants who are randomized into this study.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) as Per Blinded Independent Central Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.31', 'groupId': 'OG000', 'lowerLimit': '6.05', 'upperLimit': '10.35'}, {'value': '5.36', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '8.54'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause (Up to approximately 22 months)', 'description': 'Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \\< 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Population with Confirmed CR or PR. Intent-To-Treat Population includes all participants who are randomized into this study.'}, {'type': 'SECONDARY', 'title': '1-Year Survival Rate', 'timeFrame': 'Up to 49 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}, {'id': 'OG002', 'title': 'Crossover Adagrasib', 'description': 'Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID).'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '298', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Any Treatment-Related TEAE', 'categories': [{'measurements': [{'value': '280', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Any Treatment-Emergent SAE', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Any Treatment-Related Treatment-Emergent SAE', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE Leading to Discontinuation of Treatment', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)', 'description': 'Treatment Emergent Adverse Events (TEAEs) are those that first occur or increase in severity on or after the first dose and not more than 28 days after the last dose, and prior to the initiation of subsequent systemic anti-cancer therapy. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all the participants who received at least one dose of the study drug. Docetaxel arm do not include adverse events after initiation of crossover Adagrasib treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Hematology Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}, {'id': 'OG002', 'title': 'Crossover Adagrasib', 'description': 'Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID).'}], 'classes': [{'title': 'Anemia Grade 0', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Anemia Grade 1', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Anemia Grade 2', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Anemia Grade 3', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Anemia Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anemia Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes count decreased Grade 0', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes count decreased Grade 1', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes count decreased Grade 2', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes count decreased Grade 3', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes count decreased Grade 4', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes count decreased Missing', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils count decreased Grade 0', 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils count decreased Grade 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils count decreased Grade 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils count decreased Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils count decreased Grade 4', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils count decreased Missing', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Platelets count decreased Grade 0', 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Platelets count decreased Grade 1', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Platelets count decreased Grade 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets count decreased Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets count decreased Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Platelets count decreased Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell decreased Grade 0', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell decreased Grade 1', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell decreased Grade 2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell decreased Grade 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell decreased Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'White blood cell decreased Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)', 'description': 'Blood samples were collected to assess hematology parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all the participants who received at least one dose of the study drug. Docetaxel arm do not include adverse events after initiation of crossover Adagrasib treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Chemistry Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}, {'id': 'OG002', 'title': 'Crossover Adagrasib', 'description': 'Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID).'}], 'classes': [{'title': 'Alanine Aminotransferase increased Grade 0', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Alanine Aminotransferase increased Grade 1', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Alanine Aminotransferase increased Grade 2', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Alanine Aminotransferase increased Grade 3', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Alanine Aminotransferase increased Grade 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alanine Aminotransferase increased Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hypoalbuminemia Grade 0', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Hypoalbuminemia Grade 1', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Hypoalbuminemia Grade 2', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Hypoalbuminemia Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypoalbuminemia Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypoalbuminemia Missing', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia Grade 0', 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia Grade 1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia Missing', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia Grade 0', 'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia Grade 1', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia Grade 2', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia Missing', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase increased Grade 0', 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase increased Grade 1', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase increased Grade 2', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase increased Grade 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase increased Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase increased Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Amylase increased Grade 0', 'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Amylase increased Grade 1', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Amylase increased Grade 2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Amylase increased Grade 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Amylase increased Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Amylase increased Missing', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate Aminotransferase increased Grade 0', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate Aminotransferase increased Grade 1', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate Aminotransferase increased Grade 2', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate Aminotransferase increased Grade 3', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate Aminotransferase increased Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate Aminotransferase increased Missing', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin increased Grade 0', 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin increased Grade 1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin increased Grade 2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin increased Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin increased Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin increased Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine increased Grade 0', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine increased Grade 1', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine increased Grade 2', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine increased Grade 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine increased Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine increased Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Fasted Hypoglycemia Grade 0', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Fasted Hypoglycemia Grade 1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Fasted Hypoglycemia Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Fasted Hypoglycemia Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fasted Hypoglycemia Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fasted Hypoglycemia Missing', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Lipase Increased Grade 0', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Lipase Increased Grade 1', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Lipase Increased Grade 2', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Lipase Increased Grade 3', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lipase Increased Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lipase Increased Missing', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Hypermagnesemia Grade 0', 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Hypermagnesemia Grade 1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypermagnesemia Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypermagnesemia Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypermagnesemia Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypermagnesemia Missing', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hypomagnesemia Grade 0', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Hypomagnesemia Grade 1', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Hypomagnesemia Grade 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypomagnesemia Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypomagnesemia Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypomagnesemia Missing', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Non-Fasted Hypoglycemia Grade 0', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Non-Fasted Hypoglycemia Grade 1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Non-Fasted Hypoglycemia Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Non-Fasted Hypoglycemia Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Non-Fasted Hypoglycemia Grade 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Non-Fasted Hypoglycemia Missing', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia Grade 0', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia Grade 1', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia Grade 2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia Grade 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia Missing', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia Grade 0', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia Grade 1', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia Grade 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia Missing', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia Grade 0', 'categories': [{'measurements': [{'value': '272', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia Grade 1', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia Grade 0', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia Grade 1', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia Grade 2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia Grade 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hyperuricemia Grade 0', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Hyperuricemia Grade 1', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Hyperuricemia Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperuricemia Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperuricemia Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperuricemia Missing', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)', 'description': 'Blood samples were collected to assess chemistry parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all the participants who received at least one dose of the study drug. Docetaxel arm do not include adverse events after initiation of crossover Adagrasib treatment.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Adagrasib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '295', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib 200 mg BID', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 200 mg BID Adagrasib orally.'}, {'id': 'OG001', 'title': 'Adagrasib 400 mg QD', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 400 mg QD Adagrasib orally.'}, {'id': 'OG002', 'title': 'Adagrasib 400 mg BID', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 400 mg BID Adagrasib orally.'}, {'id': 'OG003', 'title': 'Adagrasib 600 mg QD', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 600 mg QD Adagrasib orally.'}, {'id': 'OG004', 'title': 'Adagrasib 600 mg BID', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered with study treatment in 3-week cycle and were administered 600 mg BID Adagrasib orally.'}], 'classes': [{'title': 'Cycle 1 Day 1 Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '295', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 1 Day 1 Peak', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '280', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG002'}, {'value': '556.963', 'spread': '63.550', 'groupId': 'OG003'}, {'value': '518.944', 'spread': '86.625', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 2 Day 1 Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '194', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG000'}, {'value': '1579.040', 'spread': '54.432', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG003'}, {'value': '2097.813', 'spread': '67.912', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 2 Day 1 Peak', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '175', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG001'}, {'value': '2011.347', 'spread': '39.333', 'groupId': 'OG002'}, {'value': '2331.298', 'spread': '59.515', 'groupId': 'OG003'}, {'value': '2117.333', 'spread': '62.744', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 3 Day 1 Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '130', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG003'}, {'value': '1865.408', 'spread': '42.930', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 5 Day 1 Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1114.046', 'spread': '39.300', 'groupId': 'OG002'}, {'value': '917.541', 'spread': '73.596', 'groupId': 'OG003'}, {'value': '1459.470', 'spread': '39.094', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 7 Day 1 Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Concentrations that are below the limit of quantification (BLQ) are treated as NA', 'groupId': 'OG001'}, {'value': '1062.114', 'spread': '33.842', 'groupId': 'OG002'}, {'value': '863.539', 'spread': '42.917', 'groupId': 'OG003'}, {'value': '1548.018', 'spread': '41.166', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of Cycle 1 (Pre-Dose and Peak), Cycle 2 (Pre-Dose and Peak), Cycle 3 (Pre-Dose), Cycle 5 (Pre-Dose), Cycle 7 (Pre-Dose) (Each cycle is of 21 days)', 'description': 'Blood samples were collected for assessment of plasma concentration of Adagrasib. Data for participants for which the dose was reduced after receiving starting dose of 600 mg BID, based on physician decision is presented in separate arms.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK evaluable population is defined as patients who received at least one dose of active study drug and had at least one blood sample collected to assess PK concentrations'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000', 'lowerLimit': '-7.9', 'upperLimit': '-0.2'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '8.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)', 'description': 'The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Least Square Mean and Confidence Interval are from a repeated measures model on the response variable change from baseline in LCSS average total score.', 'unitOfMeasure': 'Score on a sclae', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Population includes all participants who are randomized into this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '-2.5'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '6.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)', 'description': 'The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average symptom burden index score assesses the following six items (Appetite loss, fatigue, cough, shortness of breath, blood in sputum, pain) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The average symptom burden score is average of all the 6 items ranging from 0 to 100 where high score represent worst outcome. Least square mean and CI are from a repeated measures model on the response variable change from baseline in average symptom burden index score.', 'unitOfMeasure': 'Score on a sclae', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Population includes all participants who are randomized into this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-20.3', 'upperLimit': '14.3'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '34.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)', 'description': 'The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average 3-item global index score assesses the following 3 items (Distress/severity of symptoms from lung cancer, impact on normal activities, quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The 3 item global index score is average of all the 3 items ranging from 0 to 100 where high score represent worst outcome. LS mean and CI are from a repeated measures model on the response variable change from baseline in 3-item global index score.', 'unitOfMeasure': 'Score on a sclae', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Population includes all participants who are randomized into this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Visual Analogue Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-4.4', 'upperLimit': '4.5'}, {'value': '-3.7', 'groupId': 'OG001', 'lowerLimit': '-8.5', 'upperLimit': '1.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)', 'description': "The Visual Analogue Score (VAS) is a component of the EQ-5D-5L and assesses the patient's self-rated health using a vertical visual analogue scale where numbered 0 (the worst health you can image) to 100 (the best health you can imageine). The smallest change considered clinically meaningful, is defined as a score difference of 7 points.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Population includes all participants who are randomized into this study. LS mean and CI are from a repeated measures model on the response variable change from baseline in visual analogue scale.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0350', 'groupId': 'OG000', 'lowerLimit': '-0.0977', 'upperLimit': '0.0277'}, {'value': '-0.0914', 'groupId': 'OG001', 'lowerLimit': '-0.1572', 'upperLimit': '-0.0256'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)', 'description': "The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.594 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. Least square mean and CI are from a repeated measures model on the response variable change from baseline in health utility index.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat Population includes all participants who are randomized into this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'FG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'Safety Population', 'comment': 'Participants who received at least one dose of study treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'Cross Over', 'comment': 'Eligible participants receiving Docetaxel based on physician switched to treatment with Adagrasib', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Patients who crossed over from Docetaxel to Adagrasib are included in the Docetaxel arm only.', 'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '69'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '453', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adagrasib', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).'}, {'id': 'BG001', 'title': 'Docetaxel', 'description': 'Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\\^2 over 1 hour or according to institutional practices.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '8.66', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '7.81', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '8.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '303', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-24', 'size': 1330227, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-20T01:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 453}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05162443', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-07-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2020-12-21', 'resultsFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-20', 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) as Per Blinded Independent Central Review', 'timeFrame': 'From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)', 'description': 'Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of 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': 'From randomization till death due to any cause (up to approximately 143 weeks)', 'description': 'Overall survival is defined as the time from randomization to the date of death due to any cause.'}, {'measure': 'Objective Response Rate (ORR) as Per Blinded Independent Central Review', 'timeFrame': 'From randomization till death or till disease progression or initiation of follow-up anti-cancer therapy or withdrawal of consent prior to minimum efficacy follow-up (up to 143 weeks)', 'description': 'Objective Response Rate (ORR) is defined as the percent of participants documented to have a confirmed complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \\< 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.'}, {'measure': 'Duration of Response (DOR) as Per Blinded Independent Central Review', 'timeFrame': 'First documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause (Up to approximately 22 months)', 'description': 'Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \\< 10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. All target lesions must be assessed. Disease progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm.'}, {'measure': '1-Year Survival Rate', 'timeFrame': 'Up to 49 months'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)', 'description': 'Treatment Emergent Adverse Events (TEAEs) are those that first occur or increase in severity on or after the first dose and not more than 28 days after the last dose, and prior to the initiation of subsequent systemic anti-cancer therapy. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Hematology Parameters', 'timeFrame': 'From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)', 'description': 'Blood samples were collected to assess hematology parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.'}, {'measure': 'Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Chemistry Parameters', 'timeFrame': 'From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)', 'description': 'Blood samples were collected to assess chemistry parameters. Adverse events are graded on a scale from 0 to 4 based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with Grade 0 being normal Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.'}, {'measure': 'Plasma Concentration of Adagrasib', 'timeFrame': 'Day 1 of Cycle 1 (Pre-Dose and Peak), Cycle 2 (Pre-Dose and Peak), Cycle 3 (Pre-Dose), Cycle 5 (Pre-Dose), Cycle 7 (Pre-Dose) (Each cycle is of 21 days)', 'description': 'Blood samples were collected for assessment of plasma concentration of Adagrasib. Data for participants for which the dose was reduced after receiving starting dose of 600 mg BID, based on physician decision is presented in separate arms.'}, {'measure': 'Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Total Score', 'timeFrame': 'Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)', 'description': 'The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Least Square Mean and Confidence Interval are from a repeated measures model on the response variable change from baseline in LCSS average total score.'}, {'measure': 'Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index Score', 'timeFrame': 'Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)', 'description': 'The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average symptom burden index score assesses the following six items (Appetite loss, fatigue, cough, shortness of breath, blood in sputum, pain) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The average symptom burden score is average of all the 6 items ranging from 0 to 100 where high score represent worst outcome. Least square mean and CI are from a repeated measures model on the response variable change from baseline in average symptom burden index score.'}, {'measure': 'Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score', 'timeFrame': 'Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)', 'description': 'The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire for average 3-item global index score assesses the following 3 items (Distress/severity of symptoms from lung cancer, impact on normal activities, quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The 3 item global index score is average of all the 3 items ranging from 0 to 100 where high score represent worst outcome. LS mean and CI are from a repeated measures model on the response variable change from baseline in 3-item global index score.'}, {'measure': 'Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Visual Analogue Scale Score', 'timeFrame': 'Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)', 'description': "The Visual Analogue Score (VAS) is a component of the EQ-5D-5L and assesses the patient's self-rated health using a vertical visual analogue scale where numbered 0 (the worst health you can image) to 100 (the best health you can imageine). The smallest change considered clinically meaningful, is defined as a score difference of 7 points."}, {'measure': 'Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score', 'timeFrame': 'Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)', 'description': "The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.594 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points. Least square mean and CI are from a repeated measures model on the response variable change from baseline in health utility index."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['KRAS G12C', 'Non-small cell lung cancer', 'NSCLC', 'Metastatic Cancer', 'Docetaxel', 'Phase 3 Clinical Trial', 'Adagrasib', 'KRAS', 'KRAZATI'], 'conditions': ['Metastatic Non Small Cell Lung Cancer', 'Advanced Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '40783289', 'type': 'DERIVED', 'citation': 'Barlesi F, Yao W, Duruisseaux M, Doucet L, Martinez AA, Gregorc V, Juan-Vidal O, Lu S, De Bondt C, de Marinis F, Linardou H, Kim YC, Jotte R, Felip E, Lo Russo G, Reck M, Michenzie MF, Yang W, Meade JN, Korytowsky B, Mok TSK; KRYSTAL-12 Investigators. Adagrasib versus docetaxel in KRASG12C-mutated non-small-cell lung cancer (KRYSTAL-12): a randomised, open-label, phase 3 trial. Lancet. 2025 Aug 9;406(10503):615-626. doi: 10.1016/S0140-6736(25)00866-9.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.\n* Candidacy to receive treatment with docetaxel.\n\nCrossover Inclusion Criteria:\n\n* Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR\n* ECOG performance status 0-2\n\nExclusion Criteria:\n\n* Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).\n* Active brain metastases.\n\nCrossover Exclusion Criteria:\n\n* Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.'}, 'identificationModule': {'nctId': 'NCT04685135', 'acronym': 'KRYSTAL-12', 'briefTitle': 'Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mirati Therapeutics Inc.'}, 'officialTitle': 'A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation', 'orgStudyIdInfo': {'id': 'CA239-0013'}, 'secondaryIdInfos': [{'id': 'CA239-0013', 'type': 'OTHER', 'domain': 'Bristol-Myers Squibb Protocol ID'}, {'id': '849-012', 'type': 'OTHER', 'domain': 'Mirati Therapeutics Protocol ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRTX849', 'interventionNames': ['Drug: MRTX849']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Docetaxel', 'interventionNames': ['Drug: Docetaxel']}], 'interventions': [{'name': 'MRTX849', 'type': 'DRUG', 'otherNames': ['adagrasib', 'KRAZATI'], 'description': '21 day cycles', 'armGroupLabels': ['MRTX849']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': '21 day cycles', 'armGroupLabels': ['Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 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