Summary of AEs
. | 6-wk base study . | . | 6-mo extension study . | . | ||
|---|---|---|---|---|---|---|
. | Placebo . | Etoricoxib 90 mg . | Rofecoxib 25 mg . | Etoricoxib 90 mg . | ||
| No. of patients | 51 | 51 | 19 | 74 | ||
| Any AE (%) | 15 (29.4) | 26 (51.0) | 10 (52.6) | 47 (63.5) | ||
| Any serious AE* (%) | 0 (0.0) | 2 (3.9) | 1 (5.3) | 5 (6.8) | ||
| Most common AEs†, no. of patients (%) | ||||||
| Upper respiratory infection | 1 (2.0) | 3 (5.9) | 2 (10.5) | 2 (2.7) | ||
| Headache | 5 (9.8) | 1 (2.0) | 1 (5.3) | 4 (5.4) | ||
| Nausea | 0 (0.0) | 1 (2.0) | 1 (5.3) | 3 (4.1) | ||
| Vomiting | 0 (0.0) | 1 (2.0) | 1 (5.3) | 3 (4.1) | ||
| Cough | 0 (0.0) | 0 (0.0) | 1 (5.3) | 3 (4.1) | ||
| Renovascular AEs, no. of patients (%) | ||||||
| Lower extremity edema (LEE) | 0 (0.0) | 1 (2.0) | 1 (5.3) | 0 (0.0) | ||
| Congestive heart failure | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
| Hypertension (HTN)‡ | 0 (0.0) | 1 (2.0) | 1 (5.3) | 2 (2.7) | ||
. | 6-wk base study . | . | 6-mo extension study . | . | ||
|---|---|---|---|---|---|---|
. | Placebo . | Etoricoxib 90 mg . | Rofecoxib 25 mg . | Etoricoxib 90 mg . | ||
| No. of patients | 51 | 51 | 19 | 74 | ||
| Any AE (%) | 15 (29.4) | 26 (51.0) | 10 (52.6) | 47 (63.5) | ||
| Any serious AE* (%) | 0 (0.0) | 2 (3.9) | 1 (5.3) | 5 (6.8) | ||
| Most common AEs†, no. of patients (%) | ||||||
| Upper respiratory infection | 1 (2.0) | 3 (5.9) | 2 (10.5) | 2 (2.7) | ||
| Headache | 5 (9.8) | 1 (2.0) | 1 (5.3) | 4 (5.4) | ||
| Nausea | 0 (0.0) | 1 (2.0) | 1 (5.3) | 3 (4.1) | ||
| Vomiting | 0 (0.0) | 1 (2.0) | 1 (5.3) | 3 (4.1) | ||
| Cough | 0 (0.0) | 0 (0.0) | 1 (5.3) | 3 (4.1) | ||
| Renovascular AEs, no. of patients (%) | ||||||
| Lower extremity edema (LEE) | 0 (0.0) | 1 (2.0) | 1 (5.3) | 0 (0.0) | ||
| Congestive heart failure | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
| Hypertension (HTN)‡ | 0 (0.0) | 1 (2.0) | 1 (5.3) | 2 (2.7) | ||
No discontinuations due to LEE or HTN occurred.
Serious AEs included hemorrhoids, hemorrhagic duodenal/gastric ulcer, erosive gastritis, amputation, subdural hematoma, hemorrhage and hypotension
Incidence ≥ 5% in any treatment group
In addition to the hypertension AEs reported in the table, an additional patient receiving etoricoxib 90 mg experienced an AE of borderline hypertension in the 6-mo extension period