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Table 2 Underlying data on the three positive controls not detected by standard disproportionality (IC025 > 0) that were highest ranked by vigiRank, and the three positive controls that were lowest ranked by vigiRank

From: Improved Statistical Signal Detection in Pharmacovigilance by Combining Multiple Strength-of-Evidence Aspects in vigiRank

Drug Adverse reaction Nr. of reports Data on considered variablesa vigiRank rankb IC025 IC025 rankb
INF NAR DCH RCH CAU CAU+  TTO SOL MUL REC DIS GEO TRE
Olanzapine Bradycardia 105 4 (1.10) 7 (0.56) 25 4 4 2 46 32 12 67 (0.00) Yesc (0.77) 10 (0.22) No 54 −0.30 1882
Clopidogrel Stevens-Johnson syndrome 25 5 (1.22) 5 (0.56) 5 0 3 0 13 4 3 22 (0.00) No (0.00) 5 (0.15) No 157 −0.73 2448
Clopidogrel Myalgia 69 4 (1.10) 15 (0.56) 12 3 5 0 21 11 9 48 (0.00) No (0.00) 6 (0.20) No 173 −0.82 2582
Raloxifene Arterial thrombosis 3 0 (0.00) 1 (0.00) 0 0 0 0 0 2 1 1 (−0.42) No (0.00) 2 (0.00) No 4720 −1.04 2862
Pramipexole Hyperkinesia 3 0 (0.00) 0 (0.00) 0 0 0 0 2 0 0 1 (−0.42) No (0.00) 2 (0.00) No 4720 −1.71 3712
Nelfinavir Erythema multiforme 10 0 (0.00) 0 (0.00) 5 0 1 0 6 1 1 0 (−1.06) No (0.00) 3 (0.00) No 5291 −1.15 3006
  1. ADR adverse drug reaction, IC information component, INF informative reporting
  2. aNumbers in parentheses indicate how much the variables contribute to the algorithm’s score, for a particular drug–ADR pair. For example, the four reports on INF for olanzapine–bradycardia are transformed to 0.9 (see Fig. 1) and multiplied with 1.22 (the INF coefficient, see Fig. 2a) to yield 1.10. Full names of all variables are provided in Table 1
  3. bOut of 5,544 drug–ADR pairs in total. vigiRank’s rank for a given drug–ADR pair is based on the predicted probability (see Fig. 3)
  4. cIC005 > 0 in the two age groups 12–17 years and 18–44 years (see Sect. 2.1.2)