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Causality: well established
Causality assessment · Causality: well established
Pomalidomide and Plasma Cell Myeloma: 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.
Pomalidomide ↔ Plasma Cell Myeloma
n=8,060 co-reports · PRR 53.2 · ROR 57.7
Daratumumab is a CD38-directed antibody for multiple myeloma. Infusion site extravasation is not pharmacologically plausible; it is an administration error. 1,694 co-reports (PRR 11.8) reflect the chemotherapy population.
Coding artifact: administration error.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | not established | Administration artifact |
| Strength | not established | Not a drug effect |
| Consistency | not established | Not reproduced in controlled settings |
| Specificity | not established | No specificity |
| Biological gradient | not established | No gradient |
| Plausibility | not established | No mechanism |
| Coherence | not established | Artifact |
| Experiment | not established | Not an endpoint |
| Analogy | not established | N/A |
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.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for Pomalidomide captured plasma cell myeloma as a tracked adverse event in a usable structure. Extravasation is an administration complication, not a drug-caused AE.