{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"The number of patients who are progression-free at 6 months will be assessed based on reported data. Patients who are progression-free will have not had an haematological relapse or organ progression.\n\nHaematological relapse is defined as:\n\nFrom CR: Increase in the aberrant serum free light chain concentration to outside the normal range and by a factor of ≥2 from that at the time of CR or re-appearance of the original paraprotein\n\nFrom PR or VGPR: Increase in the aberrant free light chain concentration by a factor of ≥2 from that at the time of PR (≥50% change in ratio away from normal in patients with renal failure) or doubling of the serum paraprotein level (if starting \\>5g/L) or doubling and increase of serum paraprotein to \\>5g/L (if starting \\<5g/L)\n\nOrgan progression is defined, by organ, as:\n\nHeart: Interventricular septal thickness increased by \\>2 mm compared with baseline or 20% decline in ejection fraction\n\nKidney: 50% increase (at least 1 g/day) in 24-hr urinary","groups":[{"description":"All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.","id":"OG000","title":"Dose Level 0- Safety Population"},{"description":"All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.","id":"OG001","title":"Dose Level 1- Safety Population"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"6 months","title":"Number of Patients Progression-free at 6 Months Based on Reported Data.","type":"SECONDARY","unitOfMeasure":"Participants"}