Computing limits on medicine risks based on collections of individual case reports

Table 3 Data used to compute limits and reference values for the risk of coeliac disease following antihypertensive treatment

Drug	$N_{xy}^{R}$ ^*	$N_{x}^{R}$	$N_{x}^{E}$ ^‡	Reference risk
Amlodipine	26	23,272	8.1 million	361 events in 991,184 users
Atenolol	12	18,166	3.7 million	181 events in 452,985 users
Hydrochlorothiazide	20	17,786	7.4 million	294 events in 913,563 users
Losartan	9	7,232	3.5 million	174 events in 440,583 users
Olmesartan	31	5,243	1.2 million	40 events in 151,461 users
Valsartan	12	11,603	2.3 million	118 events in 290,305 users

*Reports with MedDRA preferred term ’Coeliac disease’.
^‡This estimate is the actual number of users in the Mini-Sentinel cohort scaled up according to the number of eligible patients and the total number of US citizens.
The reference values were obtained from a Mini-Sentinel report [18], and the limits were computed based on US reports in VigiBase. All risks refer to the US population between 1^st January 2007 and 31^st December 2011.

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