{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"33"}]}],"title":"Any adverse event (AE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"23"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"21"}]}],"title":"AE Grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"11"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"1"}]}],"title":"AEs leading to discontinuation of carfilzomib"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"}]}],"title":"AEs leading to discontinuation of lenalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"}]}],"title":"AEs leading to discontinuation of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Fatal adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"30"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"32"}]}],"title":"Treatment-related adverse events (TRAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"18"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"18"}]}],"title":"Treatment-related AEs Grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"8"}]}],"title":"Treatment-related serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"1"}]}],"title":"TRAEs leading to discontinuation of carfilzomib"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"}]}],"title":"TRAEs leading to discontinuation of lenalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"}]}],"title":"TRAEs leading to discontinuation of dexamethasone"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Treatment-related fatal adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"33"}],"units":"Participants"}],"description":"Safety and tolerability were evaluated according to the type, incidence, and severity of adverse events.\n\nAn AE is defined as any untoward medical occurrence in a clinical trial subject. The event does not necessarily have a causal relationship with study treatment.\n\nA serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:\n\n* fatal\n* life threatening\n* requires in-patient hospitalization or prolongation of existing hospitalization\n* results in persistent or significant disability/incapacity\n* congenital anomaly/birth defect\n* other medically important serious event\n\nThe severity of each AE was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.","groups":[{"description":"Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.\n\nParticipants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.","id":"OG000","title":"RRMM Dose-evaluation: Carfilzomib 56 mg/m²"},{"description":"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.\n\nParticipants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.","id":"OG001","title":"RRMM Dose-evaluation: Carfilzomib 70 mg/m²"},{"description":"Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.\n\nParticipants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.","id":"OG002","title":"RRMM Dose-expansion: Carfilzomib 70 mg/m²"},{"description":"Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.\n\nParticipants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.","id":"OG003","title":"NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²"},{"description":"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.\n\nParticipants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.","id":"OG004","title":"NDMM Dose-expansion: Carfilzomib 70 mg/m²"},{"description":"Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.\n\nParticipants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.","id":"OG005","title":"NDMM Dose-expansion: Carfilzomib 56 mg/m²"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants who received at least 1 dose of study drug (safety analysis set).","reportingStatus":"POSTED","timeFrame":"From the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.","title":"Number of Participants With Adverse Events (AEs)","type":"PRIMARY","unitOfMeasure":"Participants"}