| 3 g mesalazine OD (n = 191) | 1 g mesalazine TID (n = 189) | |
| Any TEAE | 55 (28.8) | 61 (32.3) |
| Any potential treatment-related AE | 6 (3.1) | 9 (4.8) |
| AE that led to withdrawal | 7 (3.7) | 7 (3.7) |
| Most frequent TEAEs occurring in more than 3% of patients | ||
| Headache | 9 (4.7) | 15 (7.9) |
| Deterioration of ulcerative colitis | 8 (4.2) | 10 (5.3) |
| Nasopharyngitis | 6 (3.1) | 8 (4.2) |
| Any SAE | 4 (2.1) | 2 (1.1) |
| Individual SAEs | ||
| Ulcerative colitis | 4 (2.1)* | 1 (0.5) |
| Viral upper respiratory tract infection | 1 (0.5)* | 0 |
| Measles | 0 | 1 (0.5) |
Results are given as the number (%) of patients experiencing at least one treatment-emergent adverse event (TEAE).
*One patient in the OD group experienced both SAEs.
AE, adverse event; OD, once daily; SAE, serious adverse event; TID, three times daily.