{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"The percentage of patients treated who experience any grade 3 or 4 toxicity as assessed by CTCAE v4.0 throughout all treatment cycles will be assessed based on reported data.","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","populationDescription":"All patients that receive at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.","reportingStatus":"POSTED","timeFrame":"Between informed consent provided and 30 days post last trial treatment administration, up to 7 months","title":"Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0.","type":"PRIMARY","unitOfMeasure":"Participants"}