← All causality assessments
Causality: well established
Causality assessment · Causality: well established
Bleomycin and Interstitial lung disease: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Bleomycin ↔ Interstitial lung disease
n=146 co-reports · PRR 8.6 · ROR 8.7
Bleomycin causes dose-related pulmonary toxicity and fibrosis, a classic dose-limiting adverse effect that can progress to fatal respiratory failure; 146 co-reports give PRR 8.6. The label warns of pulmonary toxicity and advises monitoring of respiratory status.
Regulatory basis: bleomycin prescribing information — pulmonary toxicity/fibrosis warning; cumulative-dose limitation.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks to months, cumulative |
| Strength | met | PRR 8.6 with 146 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to bleomycin |
| Biological gradient | met | Strong cumulative-dose relation |
| Plausibility | met | Known DNA-strand-break mechanism |
| Coherence | met | Fits bleomycin pulmonary toxicity |
| Experiment | n/a | Often monitored in trials |
| Analogy | met | Analogous to other drug-induced pulmonary fibrosis |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✓ Trial evidence found — A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma (NCT01712490)
| Adverse event | A+AVD (n=662) · ABVD (n=659) | |
|---|---|---|
| Interstitial lung disease | 1/662 | 2/659 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →