Evidence map›Paper›PMID 33158080›Full record

ArticleCancers2020

Adverse Event Burden Score-A Versatile Summary Measure for Cancer Clinical Trials.

Jennifer G Le-Rademacher, Shauna Hillman, Elizabeth Storrick, Michelle R Mahoney, Peter F Thall, Aminah Jatoi, Sumithra J Mandrekar

Abstract read
In one paragraph

Article in Cancers, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing 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

23 citing papers in PubMed.

  1. Intermittent or Continuous Panitumumab Plus Fluorouracil, Leucovorin, and Irinotecan for First-Line Treatment ofJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Observational
  17. Article
  18. Article
  19. Article
  20. Utility-based Bayesian personalized treatment selection for advanced breast cancer.Journal of the Royal Statistical Society. Series C, Applied statistics · 2022
    Article
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

7 authors.

Jennifer G Le-RademacherDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.ORCID 0000-0002-2234-7430
Shauna HillmanDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.
Elizabeth StorrickDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.
Michelle R MahoneyIQVIA, Raleigh-Durham, NC 27703, USA.
Peter F ThallDepartment of Biostatistics, M.D. Anderson Cancer Center, Houston, TX 77230, USA.
Aminah JatoiDepartment of Oncology, Mayo Clinic, Rochester, MN 55905, USA.
Sumithra J MandrekarDepartment of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Lila J. Rutten · 1985 to 2026
$151.3M
NCI NIH HHS P30 CA 15083
6 · The paper itself

Abstract

This article introduces the adverse event (AE) burden score. The AE burden by treatment cycle is a weighted sum of all grades and AEs that the patient experienced in a cycle. The overall AE burden score is the total AE burden the patient experienced across all treatment cycles. AE data from two completed Alliance multi-center randomized double-blind placebo-controlled trials, with different AE profiles (NCCTG 97-24-51: 176 patients, and A091105: 83 patients), were utilized for illustration. Results of the AE burden score analyses corroborated the trials' primary results. In 97-24-51, the overall AE burden for patients on the treatment arm was 2.2 points higher than those on the placebo arm, with a higher AE burden for patients who went off treatment early due to AE. Similarly, in A091105, the overall AE burden was 1.6 points higher on the treatment arm. On the placebo arms, the AE burden in 97-24-51 remained constant over time; and increased in later cycles in A091105, likely attributable to the increase in disease morbidity. The AE burden score enables statistical comparisons analogous to other quantitative endpoints in clinical trials, and can readily accommodate different trial settings, diseases, and treatments, with diverse AE profiles.

Indexed as

adverse eventadverse event burden scoreclinical trialssafety profile

Identifiers

PMID33158080
PMCPMC7694214

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.