Evaluating Treatment Tolerability Using the Toxicity Index With Patient-Reported Outcomes Data.

ABSTRACT:

Context

Summarizing longitudinal symptomatic adverse events during clinical trials is necessary for understanding treatment tolerability. The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) provides insight for capturing treatment tolerability within trials. Tolerability summary measures, such as the maximum score, are often used to communicate the potential negative symptoms both in the medical literature and directly to patients. Commonly, the proportions of present and severe symptomatic adverse events are used and reported between treatment arms among adverse event types. The toxicity index is also a summary measure previously applied to clinician-reported CTCAE data.

Objectives

Apply the toxicity index to PRO-CTCAE dat

SUBMITTER: Langlais B 

PROVIDER: S-EPMC8816875 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature