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Causality: well established
Causality assessment · Causality: well established
Bortezomib and Peripheral neuropathy: 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.
Bortezomib ↔ Peripheral neuropathy
n=6,473 co-reports · PRR 17.3 · ROR 18.6
Bortezomib causes a dose- and schedule-dependent peripheral neuropathy, often sensory and sometimes painful, that can be dose-limiting; 6,473 co-reports give PRR 17.3. The label advises monitoring and dose modification, favouring subcutaneous administration.
Regulatory basis: bortezomib prescribing information — peripheral neuropathy; dose/schedule modification.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks, cumulative |
| Strength | met | PRR 17.3 with 6,473 co-reports |
| Consistency | met | Consistent across cohorts |
| Specificity | met | Fairly specific to proteasome inhibitors |
| Biological gradient | met | Strong dose/schedule relation |
| Plausibility | met | Plausible proteasome-inhibition mechanism |
| Coherence | met | Fits bortezomib neurotoxicity |
| Experiment | n/a | Often monitored in trials |
| Analogy | met | Analogous to thalidomide neuropathy |
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 — MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma (NCT00833833)
| Adverse event | Phase 1: 2 mg Pomalidomide (n=6) · Phase 1: 3 mg Pomalidomide (n=8) · Phase 1: 4 mg Pomalidomide (n=14) · Phase 1: 5 mg Pomalidomide (n=10) | |||
|---|---|---|---|---|
| Neuropathy peripheral | 1/6 | 0/8 | 1/14 | 3/10 |
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 →