Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: what size of data platforms and which study designs do we need to assess safety issues?

Table 3 Is sufficient exposure time available in the SOS platform to investigate the particular event of interest given an expected relative risk of six stratified by NSAID substance?

Given an RR of 6:
ATC	SUM PYs	% PYs	Asthma exacerbation	Anaphylactic shock	Upper gastrointestinal complication	Stroke	Heart failure	Acute renal failure	Stevens–Johnson syndrome	Acute liver failure	Acute myocardial infarction	Reye’s syndrome
Total NSAIDs	61,739	100	X	X	X	X	X	X
Ibuprofen^*	42,768	69.3	X	X	X	X	X	X
Non-ibuprofen⁺	18,971	30.7	X	X	(X)
Diclofenac^#	8,000	13.0	X
Naproxen^{^}	3,878	6.3	X
Mefenamic acid	2,297	3.7	X
Ketoprofen^&	946	1.5	X
Nimesulide	925	1.5	X
Piroxicam	519	0.8
Indometacin	440	0.7
Meloxicam	328	0.5
Celecoxib	258	0.4
Rofecoxib	247	0.4
Etoricoxib	218	0.4

X: denotes that enough person time is available for detection of a RR of 6 with α = 0.05 (one-sided) and ß = 0.20; (X): denotes that enough person time is available for detection of a RR of 6 with α = 0.1 (one-sided) and ß = 0.20, exclusive to the use of α = 0.05; PYs: denotes Person years.
⁺including all NSAID preparation without ibuprofen.
^*including combinations with ibuprofen.
^#including combinations with diclofenac.
^{^}including combinations with naproxen.
^&including combinations with ketoprofen.

ISSN: 1471-2431