| Number (%) of patients | ||
| MMX mesalazine 2.4 g/day (given once daily) (n = 225) | MMX mesalazine 2.4 g/day (1.2 g given twice daily) (n = 234) | |
| Any AE | 88 (39.1) | 86 (36.8) |
| Aggravated UC | 24 (10.7) | 18 (7.7) |
| Abdominal pain (NOS) | 5 (2.2) | 4 (1.7) |
| Abdominal pain upper | 1 (0.4) | 5 (2.1) |
| Nasopharyngitis | 3 (1.3) | 5 (2.1) |
| Pharyngitis | 5 (2.2) | 2 (0.9) |
| Headache | 2 (0.9) | 5 (2.1) |
| Any mild AE | 62 (27.6) | 63 (26.9) |
| Any moderate AE | 44 (19.6) | 38 (16.2) |
| Any severe AE | 7 (3.1) | 5 (2.1) |
| Any SAE | 9 (4.0) | 9 (3.8) |
| Any AE leading to withdrawal | 11 (4.9) | 10 (4.3) |
| Any AE leading to death | 0 (0.0) | 1 (0.4) |
| Any treatment-related AE | 25 (11.1) | 22 (9.4) |
| Abdominal pain (NOS) | 3 (1.3) | 2 (0.9) |
| Colitis ulcerative aggravated | 4 (1.8) | 1 (0.4) |
| Diarrhoea (NOS) | 3 (1.3) | 2 (0.9) |
| Abdominal pain upper | 1 (0.4) | 3 (1.3) |
| Summary of SAEs | ||
| Angina pectoris | 0 | 1 |
| Pulmonary oedema | 0 | 1 |
| UC | 5 | 4 |
| Chronic hepatitis | 1 | 0 |
| Lung abscess | 0 | 1 |
| Pneumonia | 0 | 2 |
| Electric shock | 0 | 1 |
| Abnormal liver function test | 1 | 0 |
| Cerebral infarction | 1 | 0 |
| Aggravated depression | 0 | 1 |
| Menometrorrhagia | 1 | 0 |
| Ovarian cyst | 1 | 0 |
| COPD exacerbation | 0 | 1 |
AE, adverse event; COPD, chronic obstructive pulmonary disease; NOS, not otherwise specified; SAE, serious adverse event; UC, ulcerative colitis.