The Immuno-oncology-Induced Cytokine Release Syndrome Patient Diary: A Content-Valid, Patient-Reported Outcome Measure.

ABSTRACT:

Introduction

Cytokine release syndrome (CRS) occurs when the immune system reacts excessively to infections or certain immunotherapies, leading to a systemic inflammatory response. The clinical presentation of CRS is highly variable, ranging from mild symptoms, such as fever and fatigue, to severe, life-threatening conditions. Currently, there is no standardized method for collecting patient-reported data on CRS experiences. This study aims to develop a novel patient-reported outcome measure (PROM) to capture patients' experience with CRS.

Methods

A comprehensive, multistep evidence-generation process was employed, including several research steps: a literature review and analysis of Sanofi clinical trial adverse event data, semi-structured interviews with clinical experts,

SUBMITTER: Wells ET 

PROVIDER: S-EPMC12647465 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature