Adverse events and NSAID related gastrointestinal adverse events.
| Events | AZD3582 (n = 437) | Naproxen (n = 417) | Placebo (n = 116) |
|---|---|---|---|
| *Four in the AZD3582 group (otorrhoea (day 49), breast cancer (day –2), duodenal ulcer and gastric erosions (day 2)), two in the naproxen group (diabetes mellitus (day 42) and unstable angina (day 49)); one in the placebo group (intestinal diverticulum (day 27)). | |||
| †Incidence ⩾3% in any treatment group. | |||
| GI, gastrointestinal; NSAID, non-steroidal anti-inflammatory drug. | |||
| Number of patients (%): | |||
| With any adverse event | 310 (71) | 295 (71) | 77 (66) |
| With any serious adverse event* | 3 (1) | 2 (0) | 1 (1) |
| Discontinued because of adverse event | 16 (4) | 16 (4) | 6 (5) |
| Adverse event (%)† | |||
| Headache | 166 (38) | 152 (36) | 42 (36) |
| Back pain | 31 (7) | 38 (9) | 11 (9) |
| Arthralgia | 24 (5) | 38 (9) | 13 (11) |
| Nasopharyngitis | 25 (6) | 24 (6) | 6 (5) |
| Pain in limb | 22 (5) | 19 (5) | 6 (5) |
| Influenza | 17 (4) | 7 (2) | 4 (3) |
| Dizziness | 8 (2) | 12 (3) | 5 (4) |
| Pharyngitis | 15 (3) | 10 (2) | 4 (3) |
| NSAID related GI symptoms (%) | |||
| Dyspepsia | 37 (8) | 41 (10) | 8 (7) |
| Upper abdominal pain | 25 (6) | 43 (10) | 10 (9) |
| Nausea | 28 (6) | 21 (5) | 6 (5) |
| Abdominal pain | 18 (4) | 25 (6) | 3 (3) |
| Diarrhoea | 23 (5) | 18 (4) | 4 (3) |
| Constipation | 17 (4) | 19 (5) | 2 (2) |
| Abdominal distension | 18 (4) | 8 (2) | 4 (3) |
| Flatulence | 15 (3) | 11 (3) | 3 (3) |
| Total incidence | 124 (28) | 132 (32) | 32 (28) |