Most commonly observed adverse events during the 52 weeks of the study treatment groups
| Adverse event | Treatment group | ||
|---|---|---|---|
| SASP n=68 | MTX n=69 | SASP+ MTX n=68 | |
| Central nervous system | |||
| Headache | 6 (9) | 3 (4) | 8 (12) |
| Vertigo | 4 (6) | 1 (1) | 2 (3) |
| Gastrointestinal disorders | |||
| Nausea | 22 (32) | 16 (23) | 33 (49) |
| Epigastralgia | 6 (9) | 4 (6) | 9 (13) |
| Liver enzymes | |||
| AST | 0 (0) | 0 (0) | 22 (3) |
| ALT | 0 (0) | 1 (1) | 6 (9) |
| Haematological disorders | |||
| Leucopenia | 7 (10) | 1 (1) | 6 (9) |
Data shown in parentheses are percentages.