Table 3.
Nine-row by three-column MOdified NARanjo Causality Scale for ICSRs (MONARCSi) drug-event pair feature weighting matrix (); populated with mean weights for importance of presence or absence of each feature in determining causality
| Feature(Row i, Column j) | Yes(1) | No(2) | UNK/NA(3) |
|---|---|---|---|
| Significant safety event(1) | W 1,1 | W 1,2 | W 1,3 |
| Previous association(2) | W 2,1 | W 2,2 | W 2,3 |
| Temporality(3) | W 3,1 | W 3,2 | W 3,3 |
| Mechanism of action(4) | W 4,1 | W 4,2 | W 4,3 |
| De-challenge(5) | W 5,1 | W 5,2 | W 5,3 |
| Re-challenge(6) | W 6,1 | W 6,2 | W 6,3 |
| Dose response(7) | W 7,1 | W 7,2 | W 7,3 |
| Experimental data(8) | W 8,1 | W 8,2 | W 8,3 |
| Confounding factors(9) | W 9,1 | W 9,2 | W 9,3 |
Each feature in the weighting matrix () is assigned a mean weight from the sample of safety professionals for both presence (i.e., confirmatory) and absence (i.e., dis-confirmatory) of features where 0 = no importance, 1 = low importance, 2 = medium importance, 3 = high importance, and 4 = very high importance. Mean feature weights are multiplied by the corresponding element in the feature matrix () and summed to create the aggregate score (see Table 1 and Eq. 1)
UNK/NA unknown/not applicable