Table 5.
Performance of signal detection methods on Centrally Authorised Products: sensitivity analysis using only adverse drug reactions identified post-marketing in the reference database
| Methods | Total SDRs | True positive | False positive | Sensitivity | PPV |
|---|---|---|---|---|---|
| ROR_n3: only serious | 24,311 | 741 | 23,570 | 27.5% | 3.0% |
| ROR_n3: including NSR | 25,012 | 757 | 24,255 | 28.0% | 3.0% |
| Change (%) | +2.9% | +2.2% | +2.9% | ||
| ROR_n5: only serious | 16,083 | 682 | 15,401 | 25.3% | 4.2% |
| ROR_n5: including NSR | 16,523 | 693 | 15,830 | 25.7% | 4.2% |
| Change (%) | +2.7% | +1.6% | +2.8% |
NSR non-serious report, PPV positive predictive value, ROR reporting odds ratio, SDRs signals of disproportionate reporting