Table 6

Treatment-emergent adverse events (TEAEs) occurring in ≥3% of subjects in any treatment group overall by history of the use of antithrombotic medication in pooled phase II/III clinical trial program

Use*No use
Placebo
n=147
Intravenous meloxicam 5–15 mg
n=192
Intravenous meloxicam 30 mg
n=303
Intravenous meloxicam 60 mg
n=87
Placebo
n=370
Intravenous meloxicam 5–15 mg n=135Intravenous meloxicam 30 mg
n=607
Intravenous meloxicam 60 mg
n=102
Subjects with ≥1 TEAE, n (%)94 (63.9)73 (38.0)202 (66.7)35 (40.2)202 (54.6)48 (35.6)295 (48.6)24 (23.5)
Number of TEAEs223112475574438660342
TEAEs, n (%)
 Nausea37 (25.2)2 (1.0)75 (24.8)3 (3.4)94 (25.4)12 (8.9)114 (18.8)8 (7.8)
 Headache11 (7.5)1 (0.5)9 (3.0)2 (2.3)43 (11.6)4 (3.0)42 (6.9)1 (1.0)
 Vomiting14 (9.5)2 (1.0)14 (4.6)024 (6.5)7 (5.2)28 (4.6)3 (2.9)
 Constipation14 (9.5)6 (3.1)32 (10.6)1 (1.1)11 (3.0)2 (1.5)29 (4.8)1 (1.0)
 Anemia5 (3.4)17 (8.9)16 (5.3)13 (14.9)1 (0.3)9 (6.7)3 (0.5)5 (4.9)
 Dizziness7 (4.8)06 (2.0)018 (4.9)026 (4.3)2 (2.0)
 Pruritus6 (4.1)015 (5.0)09 (2.4)016 (2.6)2 (2.0)
 Insomnia7 (4.8)7 (3.6)9 (3.0)3 (3.4)4 (1.1)7 (5.2)4 (0.7)3 (2.9)
 Ketonuria†4 (2.7)20 (10.4)6 (2.0)10 (11.5)1 (0.3)3 (2.2)00
  • *Within 7 days before the first dose of study drug or during the treatment period.

  • †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