{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"11"}],"units":"Participants"}],"description":"A DLT was 1 of the following adverse events likely related to abemaciclib/combination and fulfils any 1 of the following criteria graded as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0:\n\n* Any non-hematologic Grade (G) ≥3 toxicity, except:\n\n  * G3 diarrhea lasting \\<72 hr\n  * Acute irinotecan-associated diarrhea lasting \\<7 days\n  * G≥3 nausea, vomiting, constipation that lasts \\<72 hr\n  * G3 mucositis/stomatitis lasting \\<72 hr\n  * G3 fever/infection\n  * G≥3 electrolyte abnormality that lasts \\<72 hr, is not complicated, and resolves spontaneously or responds to conventional medication;\n  * G≥3 amylase/lipase that is not associated with symptoms/clinical manifestations of pancreatitis; or\n  * AST/ALT elevation resolving to eligibility criteria within 7 days;\n* Hematologic toxicities considered a DLT:\n\n  * A \\>14-day Cycle 2 delay due to neutropenia/thrombocytopenia\n  * G≥3 thrombocytopenia with significant bleeding; or\n  * G≥ 4 neutropenic fever","groups":[{"description":"Participants received:\n\n* Abemaciclib: 70 mg/m², administered orally BID.\n* Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.\n\nTreatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.","id":"OG000","title":"Part B Cohort B1"},{"description":"Participants received:\n\n* Abemaciclib: 90 mg/m², administered orally BID.\n* Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.\n\nTreatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.","id":"OG001","title":"Part B Cohort B2"},{"description":"Participants received:\n\n* Abemaciclib: 115 mg/m², administered orally BID.\n* Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle.\n\nTreatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.","id":"OG002","title":"Part B Cohort B3"},{"description":"Participants received:\n\n* Abemaciclib: 115 mg/m², administered orally BID.\n* Temozolomide: 150 mg/m²/day, administered orally on Days 1-5 of each cycle.\n\nTreatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.","id":"OG003","title":"Part B Cohort B5"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants in Part B who received at least one dose of the study drug and had evaluable data for this outcome.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (21 Day Cycle)","title":"Number or Participants With DLTs in Part B","type":"PRIMARY","unitOfMeasure":"Participants"}