A systematic review of adult admissions to ICUs related to adverse drug events

Table 6 Causality results

Required data or study	Causality assessment methods
	Kramer and colleagues [25]	WHO [26]	Naranjo and colleagues [27]	Karch-Lasagna [28]	Hallas and colleagues [29]	Begaud and colleagues [30]
Required data for causality assessment	L, Chron, D, R, LT, AEC	L, Chron, D, R, AEC, PP	L, Chron, D, R, Pl, DM, LT, AEC, Atcd, OE	L, Chron, D, R, AEC	Chron, D, R, LT, AET, Atcd	L, Chron, D, R, LT, AEC, PP
Trunet and colleagues, 1986 [10]	de, 29.7% (30); pr, 45.6% (46); po, 20.8% (21); un, 3.9% (4)
IGICE, 1987 [11]^a
Nelson and Talbert, 1996 [12]			pr, 59.6% (31)^b; po, 40.4% (21)^b		de, 15.3% (8)^b; pr, 40.4% (21)^b; po, 25% (13)^b; un, 19.3% (10)^b
Darchy and colleagues, 1999 [13]				de, 34.1% (14); pr, 34.1% (14); po, 31.8% (13)
Hammerman and Kapeliovich, 2000 [14]				ND
Lehmann and colleagues, 2005 [15]				ND
Grenouillet-Delacre and colleagues, 2007 [16]			ND			Very likely, 8.3% (11); likely, 51.5% (68); possible, 40.2% (53)
Rivkin, 2007 [17]			de, 4.8% (1); pr, 80.9% (17); po, 14.3% (3)
Schwake and colleagues, 2009 [18]		ND
Mercier and colleagues, 2010 [19]				ND
Nazer and colleagues, 2013 [20]^a

IGICE, Italian Group on Intensive Care Evaluation; ND, not documented; WHO, World Health Organization. Results of causality assessment methods: de, definite; po, possible; pr, probable; un, unlikely. Required data used for assessing causality in each method: AEC, alternative etiologic candidates (other than drugs); Atcd, antecedent of similar event to the same drug; Chron, chronology; D, clinical outcome after dechallenge; DM, clinical outcome after dose modification; L, description in the literature; LT, results of therapeutic drug monitoring or laboratory test; OE, adverse event confirmed by objective evidence; Pl, clinical outcome after placebo administration; PP, explanation by pharmacologic properties; R, clinical outcome after rechallenge. ^aThis study did not report causality assessment. ^bPooled results for the three departments.

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