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Causality: well established
Causality assessment · Causality: well established
Trastuzumab and Ejection fraction decreased: 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.
Trastuzumab ↔ Ejection fraction decreased
n=2,048 co-reports · PRR 46.5 · ROR 47.9
Trastuzumab carries a boxed warning for cardiomyopathy and left-ventricular ejection-fraction decline, particularly with anthracyclines; 2,048 co-reports give PRR 46.5. The label advises baseline and periodic cardiac monitoring.
Regulatory basis: trastuzumab (Herceptin) prescribing information — boxed warning for cardiomyopathy; ejection-fraction monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks to months |
| Strength | met | PRR 46.5, an extreme signal |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to HER2 agents |
| Biological gradient | met | Dose/regimen-related |
| Plausibility | met | Plausible HER2 cardiac mechanism |
| Coherence | met | Fits trastuzumab cardiotoxicity |
| Experiment | n/a | Often monitored in trials |
| Analogy | met | Analogous to anthracycline cardiotoxicity |
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 — Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer (NCT01670877)
| Adverse event | Part I: Neratinib Only (n=16) · Part II: Neratinib Only (ER-) (n=5) · Part II: Neratinib + Fulvestrant (ER+, Fulvestrant-naive) (n=11) · Part II: Neratinib + Fulvestrant (ER+. Prior Fulvestrant-tx) (n=24) | |||
|---|---|---|---|---|
| Ejection fraction decreased | 0/16 | 0/5 | 0/11 | 0/24 |
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 →