{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.641","value":"21.12"},{"groupId":"OG001","spread":"28.007","value":"10.51"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"17"}],"units":"Participants"}],"title":"Overall (All Randomized Participants)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.863","value":"20.07"},{"groupId":"OG001","value":"3.65"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"FLC Subtype Kappa"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.773","value":"22.31"},{"groupId":"OG001","spread":"28.868","value":"10.94"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"16"}],"units":"Participants"}],"title":"FLC Subtype Lambda"}],"denoms":[{"counts":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"17"}],"units":"Participants"}],"description":"The KCCQ-OS is a 23-item self-administered questionnaire that quantifies physical function, symptoms, social function, self-efficacy and knowledge and quality of life. It uses an ordinal, adjectival (Likert) scale. Participants provide their level of agreement or disagreement with an agree-disagree scale for a series of statements. The questionnaire captures how the participants feel physically. The overall score was calculated as the sum from all 23 items and ranges from 0 to 100, where higher scores reflected better health status (fewer symptoms, fewer social or physical limitations, and better quality of life).","dispersionType":"Standard Deviation","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":"MEAN","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'. Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signifies those participants evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 50","title":"Change From Baseline in the Kansas City Cardiomyopathy Questionnaire-Overall Score (KCCQ-OS)","type":"SECONDARY","unitOfMeasure":"score on a scale"}