{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"Any TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Any Treatment-related TEAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE was defined as an AE starting on or after first dose of study treatment.\n\nTreatment-related TEAEs were any TEAEs considered related to investigational product by the investigator. If relationship was missing, the event was assumed treatment-related.\n\nClinically significant changes from the participant's baseline values in vital signs, 12-lead electrocardiograms, and clinical laboratory safety tests were reported as AEs.","groups":[{"description":"Participants received Sotorasib 960 mg PO QD until there was evidence of disease progression, intolerance to study medication, or withdrawal of consent.","id":"OG000","title":"Sotorasib"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set: all enrolled participants who received at least 1 dose of sotorasib.","reportingStatus":"POSTED","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","title":"Number of Participants With Treatment-emergent AEs (TEAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}