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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Etoposide and Febrile neutropenia: 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.
Etoposide ↔ Febrile neutropenia
n=7,715 co-reports · PRR 37.8 · ROR 42.1
Etoposide causes dose- and schedule-dependent myelosuppression, with febrile neutropenia as a common severe toxicity; 7,715 co-reports give PRR 37.8. The label advises blood-count monitoring and dose adjustment.
Regulatory basis: etoposide prescribing information — myelosuppression; blood-count monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Days after administration |
| Strength | met | PRR 37.8, an extreme signal |
| Consistency | met | Consistent across cohorts |
| Specificity | not established | Febrile neutropenia has many causes |
| Biological gradient | met | Strong dose/schedule relation |
| Plausibility | met | Known topoisomerase-II mechanism |
| Coherence | met | Fits etoposide myelosuppression |
| Experiment | n/a | Often coded in trials |
| Analogy | met | Analogous to other epipodophyllotoxin cytopenias |
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 Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC (NCT04063163)
| Adverse event | Group A (n=389) · Group B (n=196) | |
|---|---|---|
| Febrile neutropenia | 2/389 | 3/196 |
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 →