{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"46.7","upperLimit":"76.9","value":"63.1"},{"groupId":"OG001","lowerLimit":"47.5","upperLimit":"75.0","value":"62.2"},{"groupId":"OG002","lowerLimit":"20.6","upperLimit":"53.4","value":"35.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"17"}],"units":"Participants"}],"title":"ORR by IRC (up to 8 cycles)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"17.7","upperLimit":"51.2","value":"32.2"},{"groupId":"OG001","lowerLimit":"17.5","upperLimit":"43.4","value":"28.7"},{"groupId":"OG002","lowerLimit":"10.6","upperLimit":"39.4","value":"21.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"17"}],"units":"Participants"}],"title":"Grade 3/4 Thrombocytopenia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"16.7","value":"6.2"},{"groupId":"OG001","lowerLimit":"3.1","upperLimit":"17.2","value":"7.5"},{"groupId":"OG002","lowerLimit":"0.3","upperLimit":"16.3","value":"2.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"18"}],"units":"Participants"}],"title":"Grade 3/4 Diarrhea"}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"18"}],"units":"Participants"}],"description":"The exposure-response relationship was assessed utilizing Cmax (Cycle 1 Day 1) for panobinostat versus the outcomes of ORR, grade 3/4 thrombocytopenia, and grade 3/4 diarrhea. Two statistical models were used: logistic regression models, in which these 3 outcomes were treated in a binary fashion according to their occurrence; Cox regression models, with the relevant outcomes being the time to occurrence of grade 3/4 thrombocytopenia and the time to occurrence of grade 3/4 diarrhea. Results are reported as model-based probability. An increase in the model-based probability indicates an increase in the occurrence of the outcomes (ORR, grade 3/4 thrombocytopenia, 3/4 diarrhea) with increasing values of Cmax (that is, with increasing dose of panobinostat).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.","id":"OG000","title":"Arm A - Panobinostat (20 mg, TIW)"},{"description":"Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.","id":"OG001","title":"Arm B - Panobinostat (20 mg, BIW)"},{"description":"Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.","id":"OG002","title":"Arm C - Panobinostat (10 mg, TIW)"}],"paramType":"NUMBER","populationDescription":"Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.","reportingStatus":"POSTED","timeFrame":"Up to 5.2 Years","title":"Exposure Response: Cmax for Panobinostat","type":"SECONDARY","unitOfMeasure":"percent probability"}