Skip to main content

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?

From: 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?

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           
  1. 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.
  2. +including all NSAID preparation without ibuprofen.
  3. *including combinations with ibuprofen.
  4. #including combinations with diclofenac.
  5. ^including combinations with naproxen.
  6. &including combinations with ketoprofen.