{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.096"},{"groupId":"OG001","value":"0.102"},{"groupId":"OG002","value":"0.109"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"41"}],"units":"Participants"}],"description":"Progressive disease (PD) or death rate were reported. PD or death rate per patient-year was defined as number of events (PD or death) divided by total progression-free survival (PFS) for all participants.","groups":[{"description":"Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).","id":"OG000","title":"Arm A (Long Intense)"},{"description":"Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).","id":"OG001","title":"Arm B (Intermediate)"},{"description":"Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years).","id":"OG002","title":"Arm C (Short Intense)"}],"paramType":"NUMBER","populationDescription":"Intent-to-treat (ITT) analysis set was defined as participants who were randomly assigned to one of the 3 daratumumab schedules based on interactive web response system (IWRS).","reportingStatus":"POSTED","timeFrame":"From Cycle 1 Day 1 up to 2.07 years","title":"Progressive Disease or Death Rate","type":"PRIMARY","unitOfMeasure":"events per patient-year"}