{"analyses":[{"groupDescription":"Overall","groupIds":["OG000"],"nonInferiorityComment":"Treatment Effect Estimation","nonInferiorityType":"OTHER","pValue":"0.777","statisticalMethod":"Finkelstein-Schoenfeld Test"},{"groupDescription":"Kappa","groupIds":["OG000"],"nonInferiorityComment":"Treatment Effect Estimation","nonInferiorityType":"OTHER","pValue":"0.687","statisticalMethod":"Finkelstein-Schoenfeld Test"},{"groupDescription":"Lambda","groupIds":["OG000"],"nonInferiorityComment":"Treatment Effect Estimation","nonInferiorityType":"OTHER","pValue":"0.373","statisticalMethod":"Finkelstein-Schoenfeld Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.61","upperLimit":"1.48","value":"0.95"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"}],"units":"Participants"}],"title":"Overall (All Randomized Participants)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.53","upperLimit":"4.67","value":"1.57"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"}],"units":"Participants"}],"title":"FLC Subtype Kappa"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.41","upperLimit":"1.21","value":"0.71"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"91"}],"units":"Participants"}],"title":"FLC Subtype Lambda"}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"}],"units":"Participants"}],"description":"Time to all-cause mortality was defined as the number of weeks from the date of randomization to the date of death if it is on or before the end of PETP. Participants alive at the end of PETP (LPI+18 months) were censored at their last known alive date recorded within the PETP. CVHs were events adjudicated and confirmed as such by the Clinical Event Adjudication Committee (CEAC). Hypothesis testing with the Finkelstein-Schoenfeld test and treatment effect estimation with the win-ratio method based on pairwise comparisons of participant outcomes with comparisons performed in a hierarchical manner. To calculate win ratio, participant outcomes based on time to all-cause mortality were first compared and if there was no 'winner' due to censoring then a comparison based on frequency of cardiovascular hospitalization was made. A win ratio \\>1 represents a more favorable outcome for CAEL-101 over placebo.","dispersionType":"95% Confidence Interval","groups":[{"description":"In addition to SoC plasma cell dyscrasia treatment, participants were administered either CAEL-101 or placebo as an IV infusion over approximately 2 hours until LPI+18 months.","id":"OG000","title":"Combined CAEL-101 + Plasma Cell Dyscrasia Treatment and 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'. For the win-ratio analysis, comparisons were made between participants in the 'CAEL-101 + Plasma Cell Dyscrasia Treatment' arm and the 'Placebo + Plasma Cell Dyscrasia Treatment' arm of each reporting group.","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 18-47 months after the study randomization.)","title":"A Hierarchical Combination of Time to All-cause Mortality and Frequency of Cardiovascular Hospitalizations (CVHs) Analyzed by Win Ratio","type":"PRIMARY","unitOfMeasure":"win ratio"}