Treatment-emergent adverse events (TEAEs) occurring in ≥3% in any treatment group in pooled phase II/III clinical trial program by risk category*
| General Population | >65 years with glomerular filtration rate 60‒89 mL/min/1.73 m2 | |||||||
| Placebo n=482 | Intravenous meloxicam 5–15 mg n=327 | Intravenous meloxicam 30 mg n=815 | Intravenous meloxicam 60 mg n=188 | Placebo n=35 | Intravenous meloxicam 5–15 mg n=0 | Intravenous meloxicam 30 mg n=95 | Intravenous meloxicam 60 mg n=1 | |
| Subjects with ≥1 TEAE, n (%) | 269 (55.8) | 121 (37.0) | 436 (53.5) | 58 (30.9) | 27 (77.1) | 0 | 61 (64.2) | 1 (100.0) |
| Number of TEAEs | 590 | 198 | 945 | 94 | 76 | 0 | 133 | 5 |
| TEAEs, n (%) | ||||||||
| Nausea | 121 (25.1) | 14 (4.3) | 171 (21.0) | 10 (5.3) | 10 (28.6) | 0 | 18 (18.9) | 1 (100.0) |
| Headache | 53 (11.0) | 5 (1.5) | 48 (5.9) | 2 (1.1) | 1 (2.9) | 0 | 3 (3.2) | 1 (100.0) |
| Vomiting | 35 (7.3) | 9 (2.8) | 37 (4.5) | 3 (1.6) | 3 (8.6) | 0 | 5 (5.3) | 0 |
| Constipation | 21 (4.4) | 8 (2.4) | 45 (5.5) | 2 (1.1) | 4 (11.4) | 0 | 16 (16.8) | 0 |
| Anemia | 4 (0.8) | 26 (8.0) | 14 (1.7) | 18 (9.6) | 2 (5.7) | 0 | 5 (5.3) | 0 |
| Dizziness | 24 (5.0) | 0 | 31 (3.8) | 2 (1.1) | 1 (2.9) | 0 | 1 (1.1) | 0 |
| Pruritus | 13 (2.7) | 0 | 27 (3.3) | 2 (1.1) | 2 (5.7) | 0 | 4 (4.2) | 0 |
| Insomnia | 8 (1.7) | 14 (4.3) | 11 (1.3) | 6 (3.2) | 3 (8.6) | 0 | 2 (2.1) | 0 |
| Ketonuria† | 5 (1.0) | 23 (7.0) | 6 (0.7) | 10 (5.3) | 0 | 0 | 0 | 0 |
*High risk=subjects who were >65 years with a GFR of 60–89 mL/min/1.73 m2, as calculated using the Modification of Diet in Renal Disease equation.
†Ketonuria was reported by one site in 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