{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"title":"Response within 3 months"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"title":"Response within 6 months"},{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"}],"title":"No response"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"Amyloidotic organ response rate is assessed using the following criteria:\n\nHeart - Interventricular septal thickness decreased by 2 mm or 10% improvement in ejection fraction or a 30% and 35 pMol/L reduction in NT-ProBNP (only applicable if there is no change or \\<25% improvement in renal function) or significant improvement in lateral wall TDI S wave and E/E' ratio\n\nKidney - 50% decrease (at least 0.5 g/day) in 24-hr urinary protein loss (urine protein must be\\>0.5 g/day pretreatment) without fall in creatinine clearance of ≥25% from baseline\n\nLiver - 50% decrease in abnormal alkaline phosphatase value or a decrease in liver size radiographically by at least 2 cm\n\nNerve - Improvement in electromyogram nerve conduction velocity\n\nSoft tissue - Definite clinical and/or radiographic improvement with associated functional improvement in affected tissue.\n\nThe percentage of patients who achieve organ response within 3 and 6 months of trial registration will be reported.","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":"Within 3 months and 6 months","title":"Amyloidotic Organ Response Rate Within 3 Months and 6 Months Based on Biochemical, Electrocardiographical, and Radiographical Assessment.","type":"SECONDARY","unitOfMeasure":"Participants"}