Document Classification

Section Type: RESULTS

Text: The main risk factors for SAE were indication : compared to those treated for musculoskeletal pain, patients treated for menstrual pain had an odds ratio (95 % Confidence Interval) of 0. 4 (0. 2-0. 7), sore throat 0. 6 (0. 5-0. 8), cold and flu 0. 7 (0. 6-0. 8), headache 0. 8 (0. 7-1. 0) ; concomitant use of medication contra-indicated in the drugs'labeling (OR : 2. 2 ; 1. 6-2. 9) ; increasing number of other concomitant medications : 1 : OR 1. 5 (1. 3-1. 8) ; 2-3 : OR 1. 9 (1. 6-2. 3) ; more than 3 : OR (2. 7 ; 2. 1-3. 5) ; treatment with aspirin : OR 1. 4 ; (1. 2-1. 6) but not ibuprofen : OR 0. 9 ; (0. 8-1. 1) compared to paracetamol ; history of previous GI disorder OR 1. 4 (1. 0-1. 8) ; female gender : OR 1. 3 (1. 1-1. 4).