Table 2.
Number (%) of patients with adverse events (safety population)
| Patients with adverse events | Esomeprazole | Placebo (n=801) | |
| 40 mg once daily (n=814) | 20 mg once daily (n=799) | ||
| Any adverse events, n (%) | 295 (36.2) | 297 (37.2) | 298 (37.2) |
| Fatal serious adverse events, n (%)* | 4 (0.5) | 4 (0.5) | 1 (0.1) |
| Non-fatal serious adverse events, n (%)* | 43 (5.3) | 39 (4.9) | 35 (4.4) |
| Adverse events leading to treatment withdrawal, n(%) | 30 (3.7) | 37 (4.6) | 42 (5.2) |
| Treatment-related adverse events, n (%) | 34 (4.2) | 39 (4.9) | 31 (3.9) |
| Most common adverse events, n (%) | |||
| Diarrhoea | 21 (2.6) | 27 (3.4) | 18 (2.2) |
| Headache | 15 (1.8) | 15 (1.9) | 15 (1.9) |
| Bronchitis | 11 (1.4) | 17 (2.1) | 14 (1.7) |
| Upper abdominal pain | 13 (1.6) | 7 (0.9) | 15 (1.9) |
| Influenza | 11 (1.4) | 9 (1.1) | 13 (1.6) |
| Back pain | 8 (1.0) | 9 (1.1) | 14 (1.7) |
| Nasopharyngitis | 7 (0.9) | 13 (1.6) | 10 (1.2) |
| Upper respiratory tract infection | 7 (0.9) | 8 (1.0) | 15 (1.9) |
| Dizziness | 7 (0.9) | 9 (1.1) | 12 (1.5) |
| Nausea | 15 (1.8) | 6 (0.8) | 6 (0.7) |
| Constipation | 9 (1.1) | 10 (1.3) | 6 (0.7) |
| Hypertension | 10 (1.2) | 8 (1.0) | 7 (0.9) |
| Urinary tract infection | 6 (0.7) | 10 (1.3) | 8 (1.0) |
| Dyspepsia | 7 (0.9) | 3 (0.4) | 12 (1.5) |
*
No serious adverse event was considered by the investigators to be causally related to the study drug.