{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"9"}]}],"title":"Adverse event ≥ Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"}]}],"title":"Serious adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"0"}]}],"title":"AE leading to discontinuation of carfilzomib"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"Fatal adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"8"}]}],"title":"Treatment-related adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"}]}],"title":"Treatment-related adverse event ≥ Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}]}],"title":"Serious treatment-related adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"}]}],"title":"TRAE leading to discontinuation of carfilzomib"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Treatment-related fatal adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"Determination of the severity of all adverse events was assessed following the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Fatal.\n\nA Serious AE is an AE that meets one or more of the following criteria:\n\n* Death,\n* Life-threatening experience;\n* Requires in-patient hospitalization or prolongation of an existing hospitalization,\n* Results in persistent or significant disability/incapacity,\n* Is a congenital anomaly/birth defect,\n* Important medical events that may not result in death, be life-threatening, or require hospitalization.\n\nTreatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship.","groups":[{"description":"Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.","id":"OG000","title":"Normal Renal Function"},{"description":"Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.","id":"OG001","title":"End Stage Renal Disease"}],"paramType":"NUMBER","populationDescription":"All treated participants","reportingStatus":"POSTED","timeFrame":"From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 12 October 2015; median duration of treatment was 14 weeks in the normal renal function group and 12 weeks in the ESRD group.","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"participants"}