Evidence map›Paper›PMID 40989554›Full record

ArticleContemporary clinical trials communications2025

Use of patient-reported outcomes version of the common terminology criteria for adverse events in oncology clinical trials.

Lauren Rogak, Jamie K Forschmiedt, Ethan Basch, Gina L Mazza, Minji K Lee, Eric A Meek, Brenda Ginos, Blake T Langlais, Brie N Noble, Allison M Deal and 3 more

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Lauren RogakMayo Clinic, Department of Quantitative Health Sciences, Scottsdale, AZ, USA.
Jamie K ForschmiedtUniversity of Minnesota School of Public Health: University of Minnesota Twin Cities School of Public Health, USA.
Ethan BaschUniversity of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Gina L MazzaMayo Clinic, Department of Quantitative Health Sciences, Scottsdale, AZ, USA.
Minji K LeeMayo Clinic, Department of Quantitative Health Sciences, Rochester, MN, USA.
Eric A MeekMayo Clinic, Department of Quantitative Health Sciences, Scottsdale, AZ, USA.
Brenda GinosMayo Clinic, Department of Quantitative Health Sciences, Scottsdale, AZ, USA.
Blake T LanglaisMayo Clinic, Department of Quantitative Health Sciences, Scottsdale, AZ, USA.
Brie N NobleMayo Clinic, Department of Quantitative Health Sciences, Scottsdale, AZ, USA.
Allison M DealUniversity of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Claire YeeMayo Clinic, Department of Quantitative Health Sciences, Scottsdale, AZ, USA.
Gita ThanarajasingamMayo Clinic, Division of Hematology, Rochester, MN, USA.
Amylou C DueckMayo Clinic, Department of Quantitative Health Sciences, Scottsdale, AZ, USA.

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Lila J. Rutten · 1985 to 2026
$151.3M
NCI NIH HHS P30 CA015083
6 · The paper itself

Abstract

The Patient-Reported Outcomes version of the Common Terminology for Adverse Events® (PRO-CTCAE®) item library enables patient self-reporting of symptoms in cancer clinical trials. It was developed as a companion to CTCAE v4.0. The aim of this analysis is to understand how PRO-CTCAE has been used since its release. Trials using PRO-CTCAE were identified on clinicaltrials.gov. Trial characteristics were descriptively analyzed. Number of trials by year posted on clinicaltrials.gov was tested for increasing trend using Poisson regression. Among 327 identified trials, 318 (97 %) were in oncology, 269 (82 %) were interventional, and 170 (52 %) were randomized. Number of trials significantly increased over time (

Identifiers

PMID40989554
PMCPMC12452844

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.