{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.24","upperLimit":"0.56","value":"0.36"},{"groupId":"OG001","lowerLimit":"0.26","upperLimit":"0.88","value":"0.48"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"94"}],"units":"Participants"}],"title":"Overall (All Randomized Participants)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.09","upperLimit":"1.12","value":"0.31"},{"groupId":"OG001","lowerLimit":"0.17","upperLimit":"2.14","value":"0.60"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"FLC Subtype Kappa"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.22","upperLimit":"0.56","value":"0.35"},{"groupId":"OG001","lowerLimit":"0.20","upperLimit":"0.85","value":"0.41"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"162"},{"groupId":"OG001","value":"75"}],"units":"Participants"}],"title":"FLC Subtype Lambda"}],"denoms":[{"counts":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"94"}],"units":"Participants"}],"description":"CVHs were those events that were adjudicated and confirmed as such by the CEAC. Frequency of 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 18-49 months after the study randomization.)","title":"Frequency of CVHs","type":"SECONDARY","unitOfMeasure":"CV-related hospitalizations/year"}