{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"9"}],"units":"Participants"}],"description":"DLTs were defined as any of the following adverse events that were at least possibly related to palbociclib that occurred during the first 4 weeks of therapy regardless of expectedness. Hematologic DLTs included grade 3 neutropenia with fever and sepsis, grade 3 thrombocytopenia and/or requiring a platelet transfusion on 2 separate days within a 7-day period, or any grade 4 hematologic toxicity except lymphopenia. Non-hematologic DLTs included any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with some exceptions (e.g., nausea and vomiting of \\< 5 days; diarrhea and/or electrolyte disturbances which have not been maximally treated; AST/ALT elevation that returns to levels meeting eligibility criteria within 7 days of study drug interruption and does not recur upon restarting drug), or any grade 2 non-hematologic toxicity that persists for \\> 7 days and is considered medically significant or sufficiently intolerable by patients requires treatment interruption.","groups":[{"description":"Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Stratum I, Dose Level 1 (50 mg/m2)"},{"description":"Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Stratum I, Dose Level 2 (75 mg/m2)"},{"description":"Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG002","title":"Stratum I, Dose Level 3 (95 mg/m2)"},{"description":"Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG003","title":"Stratum II, Dose Level 1 (50 mg/m2)"},{"description":"Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG004","title":"Stratum II, Dose Level 2 (75mg/m2)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Patients who received at least one dose of palbociclib were included in the analysis. One patient in stratum II dose level 2 who withdrew prior to beginning protocol therapy was excluded.","reportingStatus":"POSTED","timeFrame":"4 weeks","title":"Number of Patients Who Experienced Dose Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}