Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- Chung, A.E.
- Shoenbill, K.
- Mitchell, S.A.
- Dueck, A.C.
- Schrag, D.
- Bruner, D.W.
- Minasian, L.M.
- St Germain, D.
- O&apos
- Baumgartner, P.
- Rogak, L.J.
- Abernethy, A.P.
- Griffin, A.C.
- Basch, E.M.
DOIAbstract
Objective: The study sought to describe patient-entered supplemental information on symptomatic adverse events (AEs) in cancer clinical research reported via a National Cancer Institute software system and examine the feasibility of mapping these entries to established terminologies. Materials and Methods: Patients in 3 multicenter trials electronically completed surveys during cancer treatment. Each survey included a prespecified subset of items from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Upon completion of the survey items, patients could add supplemental symptomatic AE information in a free text box. As patients typed into the box, structured dr...
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