In cancer clinical trials, adverse events (AEs) are collected and reported using the U.S. National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [1]. To improve precision and patient-centeredness in the capture of symptomatic AEs, the NCI developed a library of patient-reported outcome (PRO) items to supplement the CTCAE, called the PRO-CTCAE [2,3] Of the 790 AEs in the CTCAE, 78 were identified as amenable to patient self-report. For each of these AEs, PRO items were created reflecting the attributes of frequency, severity, interference with usual or daily activities, amount, or presence/absence. One to three attributes were selected for any given AE depending on the content of the CTCAE criteria for that AE and the nature of that particular AE.

The PRO-CTCAE flow contains the PRO-CTCAE questionnaire and associated calculation. After form submission, the PRO-CTCAE calculation is executed automatically. It's easy to extend this flow with conditional logic based on the interpretation of the PRO-CTCAE calculation.

PRO-CTCAE questionnaire

Questions and Scoring

124 individual items represent the 78 symptomatic AEs currently in the PRO-CTCAE item library. There  are scored from 0 to 4 (or 0/1 for absent/present) and the PRO-CTCAE yields up to three patient-reported scores per symptomatic toxicity.

The full PRO-CTCAE Symptom Term list can be found here.


[1] National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. [last accessed March 16, 2015];NIH publication # 09-7473. Published May 29, 2009; Revised Version 4.03 June 14, 2010. Available at×7.pdf. \
[2] Basch EM, Reeve BB, Mitchell SA, et al. Electronic toxicity monitoring and patient-reported outcomes. Cancer J. 2011;17(4):231-234. doi:10.1097/PPO.0b013e31822c28b3\
[3] Basch E, Reeve BB, Mitchell SA, et al. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014;106(9):dju244. Published 2014 Sep 29. doi:10.1093/jnci/dju244

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