Characterizing pulmonary adverse events associated with the immune checkpoint inhibitor avelumab: a FAERS-based pharmacovigilance study from 2013 to 2024
Bibliographic record
Abstract
The rise of immunotherapies, particularly PD-L1 inhibitors like avelumab, has advanced cancer care, but its pulmonary safety profile remains unclear. Using FAERS data from 2013-2023, we evaluated respiratory complications linked to avelumab through disproportionality analysis with OpenVigil 2.1. Several significant associations emerged: bacterial pneumonia (ROR 6.79, 95% CI 2.19-21.10, n=3), pneumonitis (ROR 4.37, 95% CI 1.96-9.74, n=6), respiratory failure (ROR 3.99, 95% CI 2.31-6.90), pulmonary edema (ROR 3.40), respiratory distress (ROR 3.31), and pulmonary embolism (ROR 2.87). By contrast, non-specific pneumonia (ROR 0.97) and dyspnea (ROR 0.97) showed no signal. These results suggest avelumab may predispose to specific severe pulmonary toxicities. Clinicians should monitor for early respiratory compromise, with prospective studies warranted to clarify causality and preventative strategies.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".