Table 3

Most commonly observed adverse events during the 52 weeks of the study treatment groups

Adverse eventTreatment group
SASP n=68MTX n=69SASP+
MTX n=68
Central nervous system
Headache6  (9)3  (4)8  (12)
Vertigo4 (6)1 (1)2 (3)
Gastrointestinal disorders
Nausea22 (32)16 (23)33 (49)
Epigastralgia6 (9)4 (6)9 (13)
Liver enzymes
AST0 (0)0 (0)22 (3)
ALT0 (0)1 (1)6 (9)
Haematological disorders
Leucopenia7 (10)1 (1)6 (9)
  • Data shown in parentheses are percentages.