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Updated: Nov 28, 2025

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Published on: February 5, 2020
Adverse events reporting in phase 3 oncology clinical trials of checkpoint inhibitors: A systematic review
Aline Barhli1, Marie-Liesse Joulia1, Christophe Tournigand2
1AP-HP, Hôpital Henri Mondor, Service d'oncologie médicale, 52 avenue du Maréchal de Lattre de Tassigny, 94000 Créteil, France.
Introduction:
This study aimed at exploring adverse events (AEs) reporting in cancer trials involving immune checkpoint inhibitors (ICIs).
Method:
A systematic review on how ICIs phase 3 trials follow TRIO and 2004 CONSORT harms extension recommendations referring to toxicity was performed by two independent reviewers.
Results:
Among 46 trials included, 74 % did not present separately grade 3 and grade 4 AEs. Timing of onset and duration were reported in 30 % and 28 %, respectively. AEs occurring in <10 % of patients were only reported in 35 % of studies. Patient-related outcomes (PROs) were analyzed in only 17 % of reports. Eight articles qualified the toxicity profile as "manageable", "tolerable", "well tolerated" or "favorable" despite reporting a rate of grade 3-4 greater than 33 %.
Conclusion:
Reporting toxicity results is crucial. However, toxicity reporting is highly incomplete in clinical trials. Guidelines, new metrics and incorporation of PROs are needed for a comprehensive knowledge of toxicity profile.
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