Table 6 Summary of adverse reactions
150 mg/day600 mg/day900 mg/day
Overall incidence18.1%21.5%17.8%
(36/199)(43/200)(35/197)
Total adverse reactions, n446245
Common adverse
reactions, n (%)*
    Abdominal distension2 (1.0)2 (1.0)2 (1.0)
    Upper abdominal pain2 (1.0)4 (2.0)2 (1.0)
    Constipation3 (1.5)4 (2.0)2 (1.0)
    Diarrhoea7 (3.5)8 (4.0)8 (4.1)
    Dyspepsia3 (1.5)2 (1.0)2 (1.0)
    Loose stool1 (0.5)6 (3.0)5 (2.5)
    Stomach discomfort2 (1.0)2 (1.0)3 (1.5)
    Pruritus3 (1.5)3 (1.5)2 (1.0)
  • *The adverse reactions which were observed in 1% or more of the patients.