{"classes":[{"categories":[{"measurements":[{"comment":"Only 1 participant had events, hence confidence interval limits could not be calculated.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"22.59"},{"comment":"Only 1 participant had events, hence confidence interval limits could not be calculated.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"7.82"},{"comment":"Upper and lower limit confidence intervals cannot be calculated as both participants had the same Duration of Response of 0.03 months.","groupId":"OG005","lowerLimit":"NA","upperLimit":"NA","value":"0.03"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"2"}],"units":"Participants"}],"description":"DoR is the time between first evidence of CR or PR and disease progression or death due to any cause.\n\nRECIST was used for solid tumors and RANO was used for brain tumors.\n\n* CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO).\n* PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and \\>50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received:\n\n* Abemaciclib: 70 mg/m², administered orally twice daily (BID).\n* Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.\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 A Cohort A1"},{"description":"Participants received:\n\n* Abemaciclib: 55 mg/m², administered orally BID.\n* Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle.\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 A Cohort A-1"},{"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":"OG002","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":"OG003","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":"OG004","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":"OG005","title":"Part B Cohort B5"}],"paramType":"MEDIAN","populationDescription":"All participants in Parts A and B who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.","reportingStatus":"POSTED","timeFrame":"Date of first evidence of a CR or PR to date of objective disease progression or death due to any cause (Up to 25 Months)","title":"Duration of Response (DoR): Parts A and B.","type":"SECONDARY","unitOfMeasure":"Months"}