Table 4.
Summary of Adverse Events in Subjects Undergoing Orthopedic Surgery
| Event | Meloxicam IV (n=283) | Placebo (n=96) | ||
|---|---|---|---|---|
| Events | No. Subjects (%) | Events | No. Subjects (%) | |
| ≥1 Event | 410 | 183 (64.7) | 160 | 66 (68.8) |
| Intensity | ||||
| Mild | 248 | 137 (48.4) | 86 | 44 (45.8) |
| Moderate | 147 | 93 (32.9) | 72 | 43 (44.8) |
| Severe | 15 | 12 (4.2) | 2 | 2 (2.1) |
| Relationship | ||||
| Not related | 301 | 155 (54.8) | 100 | 49 (51.0) |
| Possibly related | 101 | 62 (21.9) | 57 | 32 (33.3) |
| Probably related | 8 | 4 (1.4) | 2 | 2 (2.1) |
| Definitely related | 0 | 0 | 1 | 1 (1.0) |
| AE-related treatment discontinuation | 1 | 1 (0.4) | 0 | 0 |
| Most Common Events (≥3%) | ||||
| Nausea | 70 | 67 (23.7) | 34 | 30 (31.3) |
| Constipation | 35 | 35 (12.4) | 13 | 13 (13.5) |
| Vomiting | 23 | 20 (7.1) | 10 | 10 (10.4) |
| GGT increased | 17 | 17 (6.0) | 5 | 5 (5.2) |
| Headache | 16 | 15 (5.3) | 5 | 5 (5.2) |
| Anemia | 13 | 12 (4.2) | 4 | 4 (4.2) |
| Insomnia | 8 | 8 (2.8) | 5 | 5 (5.2) |
| Dizziness | 6 | 6 (2.1) | 7 | 6 (6.3) |
| Hypotension | 8 | 8 (2.8) | 4 | 4 (4.2) |
| Pruritus | 8 | 8 (2.8) | 4 | 4 (4.2) |
Abbreviations: AE, adverse event; GGT, gamma-glutamyltransferase; IV, intravenous.