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Causality: well established
Causality assessment · Causality: well established
Fam-Trastuzumab Deruxtecan-Nxki and Interstitial Lung Disease: 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.
Fam-Trastuzumab Deruxtecan-Nxki ↔ Interstitial Lung Disease
n=1,020 co-reports · PRR 45.1 · ROR 50.1
Elotuzumab is a SLAMF7-directed monoclonal antibody for multiple myeloma. Infusion site extravasation is not a pharmacologically plausible effect: it is a nursing/administration error where infused drug leaks into surrounding tissue. 403 co-reports (PRR 90.7) 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 | Coherent only as 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 Fam-Trastuzumab captured interstitial lung disease as a tracked adverse event in a usable structure. Extravasation is an administration complication, not a drug-caused AE.