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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Docetaxel 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.
Docetaxel ↔ Febrile neutropenia
n=3,074 co-reports · PRR 15.2 · ROR 15.9
Docetaxel causes myelosuppression with febrile neutropenia, especially at higher doses and without growth-factor support; 3,074 co-reports give PRR 15.2. The label advises blood-count monitoring and dose adjustment.
Regulatory basis: docetaxel prescribing information — neutropenia/febrile neutropenia; blood-count monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Days after infusion |
| Strength | met | PRR 15.2 with 3,074 co-reports |
| Consistency | met | Consistent across cohorts |
| Specificity | not established | Febrile neutropenia has many causes |
| Biological gradient | met | Dose-related |
| Plausibility | met | Known antimitotic marrow suppression |
| Coherence | met | Fits docetaxel myelosuppression |
| Experiment | n/a | Often coded in trials |
| Analogy | met | Analogous to paclitaxel myelosuppression |
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 — Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer (NCT00630032)
| Adverse event | Docetaxel (n=398) · Ixabepilone (n=364) | |
|---|---|---|
| Febrile neutropenia | 56/398 | 27/364 |
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 →