Summary of adverse events (AEs) (safety analysis set*)
| Esomeprazole 20 mg (n=214) | Placebo (n=213) | |
|---|---|---|
| Mean treatment, days | 293 | 209 |
| Any AE | 155 (72.4) | 139 (65.3) |
| AE leading to discontinuation | 17 (7.9) | 22 (10.3) |
| Non-fatal serious AEs | 17 (7.9) | 15 (7.0) |
| Severe AEs | 7 (3.3) | 10 (4.7) |
| Drug-related AEs† | 31 (14.5) | 29 (13.6) |
| Abdominal distension | 2 (0.9) | 1 (0.5) |
| Anaemia | 2 (0.9) | 0 (0) |
| Constipation | 1 (0.5) | 3 (1.4) |
| Diarrhoea | 2 (0.9) | 2 (0.9) |
| Duodenitis | 1 (0.5) | 3 (1.4) |
| Erosive duodenitis | 0 (0) | 2 (0.9) |
| Erosive gastritis | 2 (0.9) | 2 (0.9) |
| Gastric polyps | 2 (0.9) | 1 (0.5) |
| Gastritis | 1 (0.5) | 2 (0.9) |
| Upper abdominal pain | 0 (0) | 3 (1.4) |
*Subjects with multiple AEs in one category are counted once. Values are n (%), unless otherwise stated.
†AE defined as having a possible relationship to study drug, as determined by the investigator. Only events reported by ≥2 patients in either treatment group are listed.