{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"94"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"94"}],"units":"Participants"}],"title":"Overall (All Safety Set Participants)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"18"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"FLC Subtype Kappa"},{"categories":[{"measurements":[{"groupId":"OG000","value":"162"},{"groupId":"OG001","value":"75"}]}],"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":"An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, at any dose, that was not necessarily related to the treatment. A TEAE was an AE with an occurrence defined as follows: last study intervention day-first study intervention day + 140 days. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Set: all randomized participants who received at least 1 dose of the study intervention. As prespecified, data collected and reported as 'Overall (All Safety Set 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, the primary analysis for the study was conducted 18-49 months after the study randomization.)","title":"Number of Participants With Treatment-emergent Adverse Events (TEAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}