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Causality: well established
Causality assessment · Causality: well established
Oxaliplatin 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.
Oxaliplatin ↔ Peripheral neuropathy
n=4,317 co-reports · PRR 13.6 · ROR 14.3
Oxaliplatin causes a distinctive peripheral neuropathy: an acute cold-sensitive sensory component and a cumulative chronic sensory loss that can limit therapy; 4,317 co-reports give PRR 13.6. The label warns of neuropathy and advises dose modification.
Regulatory basis: oxaliplatin prescribing information — acute and cumulative peripheral neuropathy; dose modification.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Acute and cumulative |
| Strength | met | PRR 13.6 with 4,317 co-reports |
| Consistency | met | Consistent across cohorts |
| Specificity | met | Fairly specific to platinum agents |
| Biological gradient | met | Strong cumulative-dose relation |
| Plausibility | met | Known dorsal-root-ganglion toxicity |
| Coherence | met | Fits oxaliplatin neurotoxicity |
| Experiment | n/a | Often monitored in trials |
| Analogy | met | Analogous to cisplatin 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 — A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer (NCT02024607)
| Adverse event | Napabucasin Plus FOLFOX6 (n=115) · Napabucasin Plus FOLFOX6 Plus Bevacizumab (n=41) · Napabucasin Plus CAPOX (n=87) · Napabucasin Plus FOLFIRI (n=156) | |||
|---|---|---|---|---|
| Neuropathy peripheral | 35/115 | 13/41 | 13/87 | 5/156 |
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 →