{"description":"Safety analysis set: all enrolled participants who received at least 1 dose of sotorasib.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":12,"description":"Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.","id":"EG000","otherNumAffected":11,"otherNumAtRisk":12,"seriousNumAffected":6,"seriousNumAtRisk":12,"title":"Sotorasib"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 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24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Hyperlipidaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 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effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Papule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Skin mass"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Liver function test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12}],"term":"Pneumothorax"}],"timeFrame":"Day 1 until the end of study (or primary data cut-off date for ongoing participants); median [min, max] duration was 5.57 [1.5, 13.7] months"}