Treatment-emergent adverse events (TEAEs) and treatment-related* TEAEs occurring in ≥3% in any treatment group in pooled phase II/III clinical trial program
| Intravenous meloxicam | ||||
| Placebo n=517 | 5–15 mg n=327 | 30 mg n=910 | 60 mg n=189 | |
| Subjects with ≥1 TEAE, n (%) | 296 (57.3) | 121 (37.0) | 497 (54.6) | 59 (31.2) |
| Anemia | 6 (1.2) | 26 (8.0) | 19 (2.1) | 18 (9.5) |
| Constipation | 25 (4.8) | 8 (2.4) | 61 (6.7) | 2 (1.1) |
| Dizziness | 25 (4.8) | 0 | 32 (3.5) | 2 (1.1) |
| Headache | 54 (10.4) | 5 (1.5) | 51 (5.6) | 3 (1.6) |
| Insomnia | 11 (2.1) | 14 (4.3) | 13 (1.4) | 6 (3.2) |
| Ketonuria† | 5 (1.0) | 23 (7.0) | 6 (0.7) | 10 (5.3) |
| Nausea | 131 (25.3) | 14 (4.3) | 189 (20.8) | 11 (5.8) |
| Pruritus | 15 (2.9) | 0 | 31 (3.4) | 2 (1.1) |
| Vomiting | 38 (7.4) | 9 (2.8) | 42 (4.6) | 3 (1.6) |
| Treatment-related TEAEs | ||||
| Subjects with ≥1 treatment-related TEAE, n (%) | 168 (32.5) | 36 (11.0) | 221 (24.3) | 24 (12.7) |
| Headache | 29 (5.6) | 1 (0.3) | 22 (2.4) | 3 (1.6) |
| Ketonuria† | 5 (1.0) | 22 (6.7) | 6 (0.7) | 9 (4.8) |
| Nausea | 87 (16.8) | 3 (0.9) | 102 (11.2) | 5 (2.6) |
| Vomiting | 23 (4.4) | 3 (0.9) | 23 (2.5) | 1 (0.5) |
*Includes TEAEs possibly, probably and definitely related.
†Ketonuria was reported by one site in study NCT01084161, where the investigator was unaccustomed to providing non-steroidal anti-inflammatory drugs for postoperative pain. This finding may reflect differences in the timing of resumption of adequate oral caloric intake and/or the use of glucose-containing electrolytes.4