Cardiovascular Eligibility Criteria and Adverse Event Reporting in Combined Immune Checkpoint and VEGF Inhibitor Trials
Authors' conclusion
In ICI and VEGFI combination trials, there is heterogeneity in cardiovascular exclusion criteria, reporting of baseline characteristics, and reporting of cardiovascular adverse events.
Study context
- Population
- Phase 2–4 RCTs of ICI and VEGFI combination therapy for solid tumors
- Participants
- 10,313 participants17 RCTs
- Primary endpoint
- Consistency and clarity of definitions and reporting of CV eligibility criteria, baseline characteristics and CV adverse events
Methodological detailsphase 2 to 4 RCTs
- Phase 2 to 4 RCTs
Primary result
As reported in the abstract
CV eligibility criteria, baseline characteristics and CV adverse event reporting
- Trials with multiple CV exclusion criteria
- 15 trials
- Trials excluding patients with prior HF, MI, hypertension or stroke
- Thirteen trials
- "Grade 1 to 4" CV adverse events reported when incidence ≥5% to 25%
- 15 trials
Original publication
Cardiovascular Eligibility Criteria and Adverse Event Reporting in Combined Immune Checkpoint and VEGF Inhibitor Trials. JACC CardioOncol. Published 27 February 2024. doi:10.
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