{"anticipatedPostingDate":"2030-11","denomUnitsSelected":"Participants","description":"The PRO-CTCAE is a patient-reported outcome measure that was developed to evaluate symptomatic toxicities in patients in cancer clinical trials; it characterizes the frequency, severity, interference, and presence or absence of symptomatic toxicities. Responses ranges from 0 (\"never,\" \"none,\" \"not at all,\" or \"absent\") to 4 (\"almost constantly,\" \"very severe,\" or \"very much\"), with a higher score indicating a higher frequency, severity, or interference of adverse events.","reportingStatus":"NOT_POSTED","timeFrame":"Up to approximately 407 weeks","title":"Number of Participants With Maximum Post-baseline Changes in Patient-reported Outcome Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Scores for Each Item Attribute","type":"SECONDARY"}