| |
HPβCD-diclofenac (n=318) |
Ketorolac (n=142) |
Placebo (n=148) |
| Bleeding AE severity |
| Number of patients with AE that was: |
| Mild, n (%) |
6 (1.9) |
7 (4.9) |
2 (1.4) |
| Moderate, n (%) |
2 (0.6) |
1 (0.7) |
2 (1.4) |
| Severe, n (%) |
1 (0.3)a |
0 |
0 |
| Relationship to treatment |
| Not related to treatment, n (%) |
9 (2.8) |
7 (4.9) |
3 (2.0) |
| Treatment-related, n (%) |
0 |
1 (0.7)b |
1 (0.7)c |
aHematoma in a patient who underwent abdominal hysterectomy;
bIncision site hematoma in a patient who underwent partial colectomy;
cHematemesis in a patient who underwent bunionectomy/foot bone procedure. |
|
