To analyze adverse drug event (ADE) signals and potential factors associated with reporting in ipilimumab and nivolumab-treated cancer data from the FDA Adverse Event Reporting System (FAERS) database.
Approach:
Key Findings:
Total of 21,712,563 reports included, with 4,600 for ipilimumab, 36,556 for nivolumab, and 10,862 for ipilimumab/nivolumab. The onset time of adverse reactions exhibited a bimodal pattern characterized by 'early concentrated outbreak + long-term persistent risk' related to age.
Stronger associations were found with colitis, adrenal insufficiency, malignant neoplasm progression, death, and intentional product use issues.
Age and weight identified as potential factors associated with reporting of adverse reactions.
Interpretation:
Findings represent hypothesis-generating signal detections rather than definitive causal risk estimations.
Limitations:
The study is based on spontaneous reporting, which may not capture all adverse events.
Data may be subject to reporting biases and underreporting.
Conclusion:
The study identifies significant pharmacovigilance signals and potential reporting-associated factors for ipilimumab, nivolumab, and their combination.
