Evaluation of the patient experience of symptomatic adverse events on Phase I clinical trials using PRO-CTCAE.

ABSTRACT:

Background

Adverse event (AE) reporting in early-phase clinical trials is essential in determining the tolerability of experimental anticancer therapies. The patient-reported outcome version of the CTCAE (PRO-CTCAE) evaluates AE components such as severity and interference in daily life. The aim of this study was to correlate the grade of clinician-reported AEs with patients' reported experience of these toxicities using PRO-CTCAE.

Methods

Patients with advanced solid tumours enrolled on Phase I clinical trials were surveyed using the PRO-CTCAE. Symptomatic AEs were recorded by physicians using the CTCAE. A logistic regression model was used to assess associations between CTCAE grade and PRO responses.

Results

Of 219 evaluable patients, 81 experienced a high-grade (3/

SUBMITTER: Watson GA 

PROVIDER: S-EPMC9596492 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature