Table 6.
MOdified NARanjo Causality Scale for ICSRs (MONARCSi) aggregate feature weightinga by safety professionals using an ordinal weighting scale (0 = no importance, 4 = very high importance) [n = 65, mean ± standard deviation]
| Feature | Present (confirmatory) | Not present (dis-confirmatory) |
|---|---|---|
| F1: Significant safety event | 3.58 ± 0.75 | 1.23 ± 1.25 |
| F2: Previous association | 3.42 ± 0.56 | 2.14 ± 0.95 |
| F3: Temporality | 2.42 ± 0.90 | 2.00 ± 1.09 |
| F4: Mechanism of action | 3.66 ± 0.57 | 2.95 ± 1.14 |
| F5: De-challenge | 2.77 ± 0.90 | 2.92 ± 1.12 |
| F6: Re-challenge | 2.86 ± 0.68 | 1.80 ± 0.94 |
| F7: Dose response | 2.63 ± 0.86 | 1.89 ± 0.97 |
| F8: Experimental data | 2.89 ± 0.89 | 1.72 ± 0.88 |
| F9: Confounding factors | 2.69 ± 0.95 | 2.95 ± 0.87 |
aDrug-event pair features that are unknown or missing are assigned a magnitude of 0.00