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Causality: well established
Causality assessment · Causality: well established
Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate and Bone Density Decreased: is the FAERS signal real?
Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate side-effect profileAll assessmentsSee in the full list
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.
Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate ↔ Bone Density Decreased
n=4,593 co-reports · PRR 398.0 · ROR 816.3
Melphalan is an alkylating agent chemotherapy. Myelosuppression is expected: DNA alkylation kills dividing cells. 440 co-reports (PRR 20.6). Boxed warning.
Boxed warning: melphalan label (myelosuppression).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 20.6 with 440 co-reports |
| Consistency | met | Reproduced across alkylating class |
| Specificity | partial | Specific to DNA alkylators |
| Biological gradient | met | Correlates with dose |
| Plausibility | met | Known DNA alkylation |
| Coherence | met | Coherent with pharmacology |
| Experiment | met | RCTs confirm |
| Analogy | met | Analogous to other alkylators |
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 Elvitegravir, captured bone density decreased as a tracked adverse event in a usable structure. Standard chemotherapy haematological endpoint.