| Adverse events | Licofelone(n = 177) | Naproxen(n = 178) | p Value |
| Gastrointestinal | 95 (53.7) | 115 (64.6) | 0.036 |
| Nausea | 11 (6.2) | 20 (11.2) | NS |
| Dyspepsia | 37 (20.9) | 49 (27.5) | NS |
| Diarrhoea | 31 (17.5) | 22 (12.4) | NS |
| Abdominal pain | 22 (12.4) | 20 (11.2) | NS |
| Cardiac | 4 (2.3) | 10 (5.6) | NS |
| Cardiac heart failure | 1 (0.6) | 2 (1.1) | NS |
| Myocardial infarction | 0 (0) | 1 (0.6) | NS |
| Renal | 21 (11.9) | 35 (19.7) | 0.044 |
| High blood pressure | 7 (4.0) | 14 (7.9) | 0.039 |
| Peripheral oedema | 15 (8.5) | 18 (10.1) | NS |
Results are shown as number (%) of patients experiencing an event.
p Values between treatment groups were assessed using a χ2 test for gastrointestinal and renal events and a Fisher exact test for cardiac events.