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. 2018 Jun 6;41(11):1073–1085. doi: 10.1007/s40264-018-0690-y

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