Table 3.
Summary of Treatment‐Emergent Adverse Events in Subjects
| Meloxicam IV (n = 538) | Placebo (n = 183) | |||
|---|---|---|---|---|
| Event | Events | No. Subjects (%) | Events | No. Subjects (%) |
| ≥1 Event | 731 | 339 (63.0) | 281 | 119 (65.0) |
| Intensity | ||||
| Mild | 493 | 267 (49.6) | 182 | 94 (51.4) |
| Moderate | 220 | 146 (27.1) | 92 | 53 (29.0) |
| Severe | 18 | 15 (2.8) | 7 | 5 (2.7) |
| Relationship | ||||
| Not related | 529 | 267 (49.6) | 186 | 89 (48.6) |
| Possibly related | 192 | 125 (23.2) | 90 | 53 (29.0) |
| Probably related | 9 | 5 (0.9) | 4 | 4 (2.2) |
| Definitely related | 1 | 1 (0.2) | 1 | 1 (0.5) |
| Adverse event‐related treatment discontinuation | 2 (0.4) | 0 | ||
| Most common events (≥3%) | ||||
| Nausea | 129 | 123 (22.9) | 58 | 51 (27.9) |
| Constipation | 51 | 51 (9.5) | 17 | 17 (9.3) |
| Vomiting | 30 | 27 (5.0) | 15 | 14 (7.7) |
| Headache | 21 | 20 (3.7) | 13 | 12 (6.6) |
| Pruritus | 21 | 21 (3.9) | 10 | 10 (5.5) |
| GGT increased | 21 | 21 (3.9) | 5 | 5 (2.7) |
| Dizziness | 15 | 15 (2.8) | 9 | 8 (4.4) |
| Anemia | 19 | 18 (3.3) | 4 | 4 (2.2) |
| ALT increased | 11 | 11 (2.0) | 7 | 7 (3.8) |
ALT indicates alanine aminotransferase; GGT, γ‐glutamyltransferase; IV, intravenous.