{"analyses":[{"ciLowerLimit":"0.97","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.15","groupIds":["OG000"],"nonInferiorityComment":"Ordinal logistic regression model was built for outcome neutropenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.","nonInferiorityType":"OTHER","paramType":"Odds Ratio (OR)","paramValue":"1.06"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"966.3","value":"1424.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"}],"units":"Participants"}],"title":"No neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"797.8","value":"2166.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"}],"units":"Participants"}],"title":"Grade 1 or 2 neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"621.8","value":"1937.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"}],"units":"Participants"}],"title":"Grade 3 or 4 neutropenia"}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"}],"units":"Participants"}],"description":"Neutrophil count decreased adverse events observed in course 1 that were at least possibly attributable to palbociclib were included in analysis. Based on the highest toxicity grade reported, all participants, irrespective of their dose level or stratum, were combined and classified into three categories: 0 = no toxicity reported, 1 = grade 1 or 2, and 2 = grade 3 or 4. Association between neutrophil count decreased and single dose palbociclib AUC for all participants was examined.","dispersionType":"Standard Deviation","groups":[{"description":"All 34 patients who had course 1 single dose palbociclib AUC data available were included in analysis. Patients were classified into no neutropenia (n = 9), grade 1 or 2 neutropenia (n = 7), and grade 3 or 4 neutropenia (n = 18).","id":"OG000","title":"All Patients"}],"paramType":"MEAN","populationDescription":"It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between neutropenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded.","reportingStatus":"POSTED","timeFrame":"Up to approximately 4 weeks","title":"Association Between Neutropenia and Single Dose Palbociclib AUC","type":"SECONDARY","unitOfMeasure":"h*ng/mL"}