Adverse events reporting in phase 3 oncology clinical trials of checkpoint inhibitors: A systematic review

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 ind...

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Bibliographic Details
Published in:Critical reviews in oncology/hematology 2021-01, Vol.157, p.103162
Main Authors: Barhli, Aline, Joulia, Marie-Liesse, Tournigand, Christophe, Kempf, Emmanuelle
Format: Article
Language:English
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Life Sciences
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Summary: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
ISSN:1040-8428
DOI:10.1016/j.critrevonc.2020.103162