Bastiaan Sallevelt

43 Performance of a trigger tool for detecting adverse drug reactions Table 2. Number of trigger-drug combinations per trigger, mean number of associated drugs and results of the causality assessment. Trigger Number of trigger-drug combinations, n (%) Mean number of associated drugs per trigger (min-max) Causality score, % (n) PPVa, % (ADR / trigger- drug combinations) Unclassifiable Unlikely Possible Probable Certain Fall / collapse / (orthostatic) hypotension/ dizziness / syncope 305 (32.4) 3.1 (1–8) 0 (0) 71.8 (219) 23.6 (72) 4.6 (14) 0 (0) 28.2 (86/305) Delirium / confusion / drowsiness 226 (24.0) 2.3 (1–6) 3.1 (7) 73.9 (167) 16.4 (37) 5.3 (12) 1.3 (3) 23.0 (52/226) Renal insufficiency and/ or dehydration 152 (16.2) 1.8 (1–4) 0.7 (1) 37.5 (57) 43.4 (66) 17.8 (27) 0.7 (1) 61.8 (94/152) Hyponatraemia 127 (13.5) 1.8 (1–4) 2.4 (3) 52.0 (66) 26.8 (34) 16.5 (21) 2.4 (3) 45.7 (58/127) Constipation / ileus 35 (3.7) 1.3 (1–2) 2.9 (1) 28.6 (10) 31.4 (11) 20.0 (7) 17.1 (6) 68.6 (24/35) Other bleedings 23 (2.4) 1.3 (1–2) 0 (0) 17.4 (4) 52.2 (12) 17.4 (4) 13.0 (3) 82.6 (19/23) Hypoglycaemia 17 (1.8) 1.7 (1–2) 0 (0) 23.5 (4) 17.6 (3) 47.1 (8) 11.8 (2) 76.5 (13/17) Hypokalaemia 14 (1.5) 1.0 (1–1) 0 (0) 0 (0) 64.3 (9) 28.6 (4) 7.1 (1) 100 (14/14) Hyperkalaemia 13 (1.4) 1.3 (1–1) 0 (0) 30.8 (4) 46.2 (6) 23.1 (3) 0 (0) 69.2 (9/13) Supratherapeutic INR 9 (1.0) 1.0 (1–1) 0 (0) 0 (0) 0 (0) 88.9 (8) 11.1 (1) 100 (9/9) Vomiting / diarrhoea 9 (1.0) 1.0 (1–1) 0 (0) 11.1 (1) 22.2 (2) 44.4 (4) 22.2 (2) 88.9 (8/9) Gastrointestinal bleeding 7 (0.7) 1.0 (1–1) 0 (0) 14.3 (1) 28.6 (2) 42.9 (3) 14.3 (1) 85.7 (6/7) Hyperglycaemia 2 (0.2) 1.0 (1–2) 0 (0) 50.0 (1) 0 (0) 50.0 (1) 0 (0) 50.0 (1/2) Fracture 1 (0.1) 1.0 (1–1) 0 (0) 100 (1) 0 (0) 0 (0) 0 (0) 0 (0/1) Acute heart failure 1 (0.1) 1.0 (1–1) 0 (0) 100 (1) 0 (0) 0 (0) 0 (0) 0 (0/1) Intracranial bleeding 0 (0.0) N/A 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) N/A Total 941 (100) 2.0 (1–8) 1.3 (12) 57.0 (536) 27.0 (254) 12.3 (116) 2.4 (23) 41.8 (393/941) aThe PPV was defined as the number of ADRs divided by the number of all detected trigger-drug combinations per trigger. 2

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