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Aim: Reporting toxicities of targeted therapies (TTs) and immunotherapy in oncology requires special attention. Materials &amp; methods: We identified TTs and immunotherapies approved by the US FDA for solid malignancies in the adult population. Publications were reviewed according to a 24-point score based on the Consolidated Standards of Reporting Trials guidance. Results: We identified 81 trials (&gt;45,000 patients). The experimental drug was studied as single agent in 51% of the cases; setting of disease was mainly (95%) advanced/metastatic. Lowest scores in adverse event (AE) description regarded: reporting recurrent/late toxicities and duration of the AEs (&gt;90%), time of occurrence and indication of all-grade AEs (&gt;75%). Conclusion: Suboptimal reporting of AEs in trials leading to approval of TTs and immunotherapy was shown. Improving AE descriptions should be a priority in ongoing trials.

Systematic Review of Adverse Events Reporting in Clinical Trials Leading to Approval of Targeted Therapy and Immunotherapy