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. 2015 May 20;80(2):304–314. doi: 10.1111/bcp.12610

Table 1.

Amount of required drug exposure to identify potentially drug-induced adverse events

Weak association (RR≥2) Moderate association (RR≥4) Strong association (RR≥6)
Event type IR per 100 000 PY Required exposure (PY) Drugs n % of Exp Required exposure (PY) Drugs n % of Exp Required exposure (PY) Drugs n % of Exp
Hip fracture 15.3 52 501 6 29.5 8039 42 67.8 3589 81 80.4
Upper GI bleeding 14.4 55 725 5 26.2 8532 39 66.3 3810 79 79.9
Neutropenia 8.1 99 259 2 13.0 15 198 25 56.9 6786 48 70.5
Acute liver injury 4.0 202 733 0 0 31 041 9 37.3 13 860 26 57.8
Pancytopenia 3.7 215 469 0 0 32 991 9 37.3 14 730 25 56.9
Bullous eruption 3.6 224 394 0 0 34 358 9 37.3 15 341 24 56.0
Anaphylactic shock 3.2 248 526 0 0 38 053 8 35.0 16 990 20 52.1
Cardiac valve fibrosis 2.9 275 840 0 0 42 235 8 35.0 18 858 15 46.6
Acute renal failure 1.6 517 050 0 0 79 168 3 17.9 35 348 9 37.3
Acute pancreatitis 1.6 519 664 0 0 79 568 3 17.9 35 527 9 37.3

Drugs (n): Number of drugs at fifth ATC, chemical substance level that have enough PY of exposure to detect a potential signal (total 2170).

% of Exp: Proportion of PYs of exposure of the drugs with enough exposure compared with the total PYs of exposure for all drugs.

IR, incidence rate; PY, person years; RR, relative risk; upper GI bleeding, upper gastrointestinal bleeding