Table 3

Number of serious adverse events (SAE) and SAE/100 patient years (pyrs) by treatment group (95% CIs are given in parenthesis)

 Continuous treatment groupOn-demand treatment group
SAESAE/100 pyrsSAESAE/100 pyrs
Cardiovascular disorders (total)32.3 (0.5 to 6.6)21.5 (0.2 to 5.4)
 Angina pectoris10.8 (0 to 4.2)
 Myocardial infarction21.5 (0.2 to 5.4)10.8 (0 to 4.2)
 Wolff–Parkinson–White syndrome10.8 (0 to 4.2)
Gastrointestinal disorders (total)10.8 (0 to 4.2)75.3 (2.1 to 10.8)
 Colitis10.8 (0 to 4.2)10.8 (0 to 4.2)
 Crohn’s disease21.5 (0.2 to 5.4)
 Diarrhoea10.8 (0 to 4.2)
 Diverticulum10.8 (0 to 4.2)
 Inguinal hernia10.8 (0 to 4.2)
 Pancreatitis acute10.8 (0 to 4.2)
Renal and urinary disorders (total)10.8 (0 to 4.2) 21.5 (0.2 to 5.4)
 Calculus ureteric10.8 (0 to 4.2)
 Nephrolithiasis21.5 (0.2 to 5.4)
Other SAE1410.6 (5.8 to 17.8)107.5 (3.6 to 13.8)
SAE total1914.4 (8.7 to 22.5)2115.8 (9.8 to 24.1)
  • Bold typeface indicates no significance for the differences between the two groups for any of the side effects.