Comply
Pharmacovigilance & Signal Detection
Literature surveillance, disproportionality and benefit-risk.
Literature surveillance
Configure search| Publication | Source | Date | Drug | Event (MedDRA) | Relevance | Status |
|---|---|---|---|---|---|---|
| Pneumonitis with anti-PD-L1 in NSCLC | PubMed | Jun 04 | CDOS-204 | Pneumonitis | 0.94 | Actionable |
| Hepatotoxicity safety signal — Phase 2 review | Embase | Jun 02 | CDOS-307 | Hepatotoxicity | 0.81 | New |
| WHO VigiBase Q2 update | VigiBase | May 28 | Multiple | Various | 0.62 | Reviewed |
Aggregate analytics (FAERS / EudraVigilance)
| Drug | Event | Cases | ROR | PRR | IC | Flag |
|---|---|---|---|---|---|---|
| CDOS-204 | Pneumonitis | 412 | 4.21 | 3.88 | 1.94 | Signal |
| CDOS-204 | Rash | 188 | 1.42 | 1.36 | 0.41 | — |
| CDOS-307 | ALT elevation | 84 | 2.84 | 2.61 | 1.18 | Signal |
Signal validation workflow
- SIG-2024-018 · CDOS-204 · PneumonitisStrongValidatedLiterature + FAERS · evaluator Dr. K. Singh · Jun 04 · action: DSUR inclusion
- SIG-2024-019 · CDOS-307 · HepatotoxicityModerateUnvalidatedFAERS · evaluator Dr. K. Singh · Jun 02 · action: Investigate
- SIG-2024-014 · CDOS-118 · QT prolongationWeakRefutedClinical · evaluator Dr. J. Liu · May 18 · action: Close