{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"DLTs were defined as any of the following adverse events (AEs) where a relationship to sotorasib could not be ruled out.\n\nHematological toxicity\n\n* febrile neutropenia\n* neutropenic infection\n* grade 4 neutropenia\n* grade ≥ 3 thrombocytopenia for \\> 7 days\n* grade 3 thrombocytopenia with grade ≥ 2 bleeding\n* grade 4 thrombocytopenia\n* grade 4 anemia.\n\nNon-hematological toxicity\n\n* grade ≥ 4 vomiting or diarrhea\n* grade 3 diarrhea or grade 3 vomiting lasting more than 3 days despite optimal medical support\n* grade ≥ 3 nausea for 3 days or more despite optimal medical support\n* any other grade ≥ 3 adverse event.","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":"DLT analysis set: DLT-evaluable subjects (participants who either experienced a DLT or did not experience a DLT but received at least 80% of the planned doses of investigational product within the 21-day DLT window) in the safety analysis set.","reportingStatus":"POSTED","timeFrame":"Day 1 to Day 21","title":"Number of Participants With Dose-limiting Toxicities (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}