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A meta-analysis of serious adverse events across different phases of clinical trials

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Meta-analysis identifies trends in serious adverse events across clinical trial phases, highlighting risk factors.

SAE rates progressively increased from Phase I (1.5%) to Phase III (7.0%), indicating a rising risk as trials advance.
Oncology and cardiovascular clinical trials exhibited the highest incidences of serious adverse events, emphasizing specific therapeutic areas of concern.
Statistical analyses revealed that demographic factors, such as age and gender, significantly impacted SAE rates across various trial phases.
Insights from Phase IV trials emphasized the importance of monitoring rare and delayed SAEs after drug approval to ensure ongoing safety.

Upadhye et al. (2025) studied this question.

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