Table 4

Adverse events of special interest (AEOSI) occurring in >1 subject 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 AEOSI, n (%)67 (13.0)41 (12.5)131 (14.4)27 (14.3)
 Bleeding*11 (2.1)30 (9.2)33 (3.6)19 (10.1)
 Cardiovascular6 (1.2)06 (0.7)2 (1.1)
 Hepatic28 (5.4)8 (2.4)42 (4.6)5 (2.6)
 Injection site reactions6 (1.2)012 (1.3)0
 Renal2 (0.4)08 (0.9)0
 Thrombotic1 (0.2)04 (0.4)0
 Wound healing*17 (3.3)4 (1.2)44 (4.8)3 (1.6)
  • *Subjects with wound hematoma were counted once in the bleeding and once in the wound-healing categories.