{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34"}]}],"title":"Any (N)SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"}]}],"title":"Any NSAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"Any SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Any (N)SADR related to daratumumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Any NSADR related to daratumumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Any SADR related to daratumumab"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"}]}],"title":"Any (N)SAE of Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"Any (N)SAE of Grade 3 or 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Any fatal SAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"38"}],"units":"Participants"}],"description":"The incidence of Adverse Events and Treatment Emergent Adverse Events in patients with refractory and relapsed multiple myeloma and renal impairment treated with daratumumab with dexamethasone was assessed according to the common Terminology Criteria for Adverse Events.","groups":[{"description":"Daratumumab:\n\nDaratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \\> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).\n\nDexamethasone:\n\nDexamethasone was administered at 40 mg (20 mg for patients \\> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.","id":"OG000","title":"Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Continuously throughout the study, starting from informed consent until 30 days after last study treatment (approximately up to 30 months).","title":"To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).","type":"SECONDARY","unitOfMeasure":"Participants"}