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

International audienceIntroduction: 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