{"groups":[{"description":"During the PETP, participants were administered CAEL-101 as an intravenous (IV) infusion over approximately 2 hours, in addition to standard-of-care (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":"FG000","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":"FG001","title":"Placebo + Plasma Cell Dyscrasia Treatment"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"22"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Participant received heart transplant or left ventricular assist device"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"84"},{"groupId":"FG001","numSubjects":"41"}],"comment":"Intent-to-treat Set: all participants who were randomized","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"84"},{"groupId":"FG001","numSubjects":"40"}],"comment":"Safety Set: all randomized participants who received at least 1 dose of the study intervention.","type":"Received at Least 1 Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"6"}],"comment":"Participants with the Kappa FLC subtype who were randomized and received at least 1 dose of study drug in this subgroup.","type":"Kappa FLC Subtype"},{"achievements":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"34"}],"comment":"Participants with the Lambda FLC subtype who were randomized and received at least 1 dose of study drug in this subgroup.","type":"Lambda FLC Subtype"},{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"14"}],"comment":"Based upon Safety Set: all randomized participants who received at least 1 dose of the study intervention.","type":"Entered OLEP"},{"achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"4"}],"comment":"Based upon Safety Set: all randomized participants who received at least 1 dose of the study intervention.","type":"Did Not Enter OLEP"},{"achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"18"}],"comment":"Only deaths indicated as leading to study discontinuation are reported in the Participant Flow section. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"23"}],"type":"NOT COMPLETED"}],"title":"PETP"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"14"}],"type":"Study ongoing"}],"milestones":[{"achievements":[{"comment":"Not every participant that completed the PETP entered the OLEP","groupId":"FG000","numSubjects":"21"},{"comment":"Not every participant that completed the PETP entered the OLEP","groupId":"FG001","numSubjects":"14"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"14"}],"type":"NOT COMPLETED"}],"title":"OLEP"}],"preAssignmentDetails":"Subgroup analyses reported for 2 free light chain (FLC) isotypes (Kappa, Lambda) as following subgroups, 'Kappa FLC Subtype' and 'Lambda FLC Subtype'. The sum of the participants for the \"CAEL-101 + Plasma Cell Dyscrasia Treatment\" Arm/Group in the \"Kappa FLC Subtype\" and \"Lambda FLC Subtype\" Rows (25+57=82) appears inconsistent with the number of participants specified in the \"Received at Least 1 Dose of Study Drug\" Row (84) due to 2 participants were not classified as either kappa or lambda","recruitmentDetails":"This study consisted of 2 periods: the Primary Evaluation Treatment Period (PETP) and the Open-label Extension Period (OLEP). Primary analysis data reported based only on data collected through the end of the participant's PETP (last participant in \\[LPI\\] plus 18 months). Final data will be reported after study completion."}