{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.54","upperLimit":"1.60","value":"0.93"},{"groupId":"OG001","lowerLimit":"0.82","upperLimit":"3.68","value":"1.73"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"title":"Overall (All Randomized Participants)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.16","upperLimit":"0.73","value":"0.34"},{"groupId":"OG001","lowerLimit":"0.74","upperLimit":"8.49","value":"2.50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"title":"FLC Subtype Kappa"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.48","upperLimit":"2.07","value":"1.00"},{"groupId":"OG001","lowerLimit":"0.50","upperLimit":"3.01","value":"1.22"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"34"}],"units":"Participants"}],"title":"FLC Subtype Lambda"}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"description":"CVHs were those events that were adjudicated and confirmed as such by the CEAC. Frequency of CEAC-adjudicated CVH was calculated using negative binomial regression analysis with study intervention, study, geographic region, daratumumab usage at Baseline, and offset term equal to log of each participant's follow-up time for cardiovascular hospitalization included in the model.","dispersionType":"95% Confidence Interval","groups":[{"description":"During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months.\n\nAll participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.","id":"OG000","title":"CAEL-101 + Plasma Cell Dyscrasia Treatment"},{"description":"During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months.\n\nAll participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.","id":"OG001","title":"Placebo + Plasma Cell Dyscrasia Treatment"}],"paramType":"NUMBER","populationDescription":"Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported as 'Overall (All Randomized Participants)' and per subgroups 'Kappa FLC Subtype' and 'Lambda FLC Subtype'.","reportingStatus":"POSTED","timeFrame":"Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, analysis for the study was conducted 18-47 months after the study randomization.)","title":"Frequency of CVHs","type":"SECONDARY","unitOfMeasure":"CV-related hospitalizations/year"}