Table 3 Summary of safety and tolerability
| Â | Placebo | Etoricoxib | Etoricoxibn | Ibuprofen |
|---|---|---|---|---|
N = 98 | 90 mg  | 120 mg | 1800 mg  | |
n(%) | N = 222 | N = 230 | N = 223 | |
| Â | n(%) | n(%) | n(%) | |
One or more AEs | 68 (69.4) | 141 (63.5) | 144 (62.6) | 134 (60.1) |
   Discontinued due to AEs | 5 (5.1) | 14 (6.3) | 8 (3.5) | 10 (4.5) |
Drug-related AEs | 3 (3.1) | 12 (5.4) | 11 (4.8) | 9 (4.0) |
   Discontinued due to Drug-related AEs | 1 (1.0) | 2 (0.9) | 1 (0.4) | 3 (1.3) |
Serious AEs | 4 (4.1) | 5 (2.3) | 4 (1.7) | 5 (2.2) |
Discontinued due to Serious AEs | 1 (1.0) | 4 (1.8) | 2 (0.9) | 2 (0.9) |
Tier 1 AEs | ||||
  CHF, pulmonary edema, or cardiac failure composite | 0 (0.0) | 1 (0.5) | 0 (0.0) | 0 (0.0) |
  Edema-related | 4 (4.1) | 2 (0.9) | 4 (1.7) | 4 (1.8) |
  Hypertension-related | 3 (3.1) | 8 (3.6) | 3 (1.3) | 7 (3.1) |
  Opioid-related | 41 (41.8) | 77 (34.7) | 84 (36.5) | 81 (36.3) |
Tier 2 AEs (AEs that occurred in ≥4 patients in any one treatment group) | ||||
  Constipation | 13 (13.3) | 26 (11.7) | 33 (14.3) | 30 (13.5) |
  Dyspepsia | 8 (8.2) | 5 (2.3) | 9 (3.9) | 10 (4.5) |
  Nausea | 31 (31.6) | 50 (22.5) | 56 (24.3) | 53 (23.8) |
  Vomiting | 13 (13.3) | 27 (12.2) | 30 (13.0) | 33 (14.8) |
  Edema peripheral | 4 (4.1) | 2 (0.9) | 4 (1.7) | 4 (1.8) |
  Pyrexia | 27 (27.6) | 13 (5.9) | 25 (10.9) | 23 (10.3) |
  Anaemia (postoperative) | 4 (4.1) | 11 (5.0) | 6 (2.6) | 6 (2.7) |
  Dizziness | 3 (3.1) | 14 (6.3) | 15 (6.5) | 14 (6.3) |
  Headache | 3 (3.1) | 9 (4.1) | 7 (3.0) | 6 (2.7) |
  Insomnia | 11 (11.2) | 23 (10.4) | 21 (9.1) | 17 (7.6) |
  Oliguria | 4 (4.1) | 2 (0.9) | 6 (2.6) | 4 (1.8) |
  Hyperhidrosis | 4 (4.1) | 14 (6.3) | 14 (6.1) | 11 (4.9) |
  Pruritus | 4 (4.1) | 19 (8.6) | 15 (6.5) | 17 (7.6) |
AEs of Interest in Postoperative Patients | ||||
  Bleeding-related AEs | 7 (7.1) | 16 (7.2) | 11 (4.8) | 14 (6.3) |
  Wound infection-related AEs | 0 (0.0) | 4 (1.8) | 1 (0.4) | 5 (2.2) |
  Wound-related AEs | 2 (2.0) | 1 (0.5) | 2 (0.9) | 2 (0.9) |
All Confirmed Thromboembolic Events | ||||
  Myocardial Infarction | 0 (0.0) | 1 (0.5) | 1 (0.4) | 0 (0.0) |
  Transient Ischemic Attack | 1 (1.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
  Pulmonary Embolism | 0 (0.0) | 1 (0.5) | 1 (0.4) | 0 (0.0) |
  Cardiac Arrest | 1 (1.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |