Treatment-emergent adverse events during the study
| Event | Placebo (n=91) | Mesalazine (n=88) |
|---|---|---|
| Adverse events | ||
| Upper respiratory tract infections | 7 (7.7%) | 11 (12.5%) |
| Diarrhoea | 10 (11.0%) | 6 (6.8%) |
| Headache | 8 (8.8%) | 5 (5.7%) |
| Nausea | 2 (2.2%) | 4 (4.6%) |
| Flatulence | 4 (4.4%) | 3 (3.4%) |
| Vomiting | 3 (3.3%) | 2 (2.3%) |
| Dyspepsia | 4 (4.4%) | 0 (0%) |
| Serious adverse events | ||
| Gastroenteritis | 0 (0%) | 2 (2.3%) |
| Ischaemic colitis | 0 (0%) | 1 (1.1%) |
| Breast cancer | 0 (0%) | 1 (1.1%) |
Adverse events are listed in descending order of frequency in the mesalazine group. The adverse events listed were reported in 2% or more of the patients in either treatment group.