Variable |
Mesalamine group (n=10) (n (%)) | Sulphasalazine group (n=12) (n (%)) | Balsalazide group (n=12) (n (%)) |
No adverse events | 15 | 27 | 14 |
No patients with adverse events | 7 (70) | 10 (83) | 8 (67) |
No patients with serious adverse events | 0 (0) | 1 (8) | 0 (0) |
No patients with severe adverse events | 1 (10) | 3 (25) | 4 (33) |
Most frequent adverse events (No events) | |||
Leucopenia (WBC <3.0×109/l) | 1 (10) | 1 (8) | 0 (0) |
Leucopenia (WBC ⩽ 3.5×109/l) | 5 (50) | 6 (50) | 2 (17) |
Headache | 1 (10) | 6 (50) | 0 (0) |
Nausea | 1 (10) | 4 (33) | 1 (8) |
Worsening diarrhoea | 1 (10) | 1 (8) | 4 (33) |
Fatigue | 1 (10) | 4 (33) | 1 (8) |
↵2-150 34 patients were screened, enrolled, and received at least one dose of study medication, and were included in the safety analysis. Elsewhere in the manuscript, results presented are for the intention to treat population (31 patients).