{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"160"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"827"}],"units":"Participants"}],"description":"The MTD is defined as the highest dose level at which none of the first 3 treated patients, or not more than 1 of the first 6 treated patients, experiences a DLT. A DLT is any adverse events that starts on or after first administration of study drug, as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.\n\n* Any Grade(G) ≥3 nonhematologic toxicity, excluding\n* G3 AST, ALT, and/or total bilirubin elevation for \\<7 days.\n* G3 neutropenia \\<7 days\n* G3 thrombocytopenia without clinically significant bleeding\n* G3 or G4 lymphopenia.\n* First occurrence of G3 or G4 electrolyte abnormalities\n* G3 fatigue, weakness, nausea; other manageable constitutional symptom\n* G3 or G4 vomiting or diarrhea that lasts for \\<48hours with antiemetic/antidiarrheal medication in case of G3 and \\<24 hours in case of G4\n* G4 manageable constitutional symptom.","groups":[{"description":"All Phase 1 Participants who received Selpercatinib (20 mg - 240 mg) orally once daily (QD) or twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.","id":"OG000","title":"Phase 1 - Selpercatinib (All Participants)"}],"paramType":"NUMBER","populationDescription":"All Participants who received at least 1 or more doses of selpercatinib and had evaluable data for this outcome.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (cycle length = 28 days)","title":"Phase 1: Maximum Tolerated Dose (MTD)","type":"PRIMARY","unitOfMeasure":"milligrams"}