What is PRO-CTCAE?
- PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials.
- It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE), the standard lexicon for adverse event reporting in cancer trials.
- PRO-CTCAE includes an item library (PDF, 138 KB) of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
- PRO-CTCAE provides a systematic yet flexible tool for descriptive reporting of symptomatic treatment side effects in cancer clinical trials.
How Do I Use PRO-CTCAE?
- PRO-CTCAE is publicly available for all to use in their clinical trials and we encourage and facilitate this use.
- PRO-CTCAE should be used and reported in conjunction with the CTCAE reports gathered by clinicians. It provides additional information that is complementary to existing safety and tolerability assessments reported by clinicians using the CTCAE.
- Choice of PRO-CTCAE items is dependent upon anticipated adverse events based upon previous preclinical data and regimen-specific information.
- Timing of assessments:
- Recall period for PRO-CTCAE is the past 7 days.
- Consider weekly assessment for key periods in the trial (eg. first two cycles in an early phase trial) or at other key clinical assessment timeframes based upon knowledge of the anticipated toxicity of the regimen.
- Once you have determined which symptomatic adverse events you wish to collect in your trial and at which timepoints of measurement, you can use our Form Builder to build a study-specific custom form.
- PRO-CTCAE responses are scored from 0 to 4, and there are as yet no standardized scoring rules for how to combine attributes into a single score or how best to analyse PRO-CTCAE data longitudinally.
- PRO-CTCAE scores for each attribute (frequency, severity and/or interference) should be presented descriptively (e.g. summary statistics or graphical presentations).
- CTCAE grades for the corresponding time period should be presented in conjunction with PRO-CTCAE scores.