|
HPβCD-diclofenac (n=318) |
Ketorolac (n=142) |
Placebo (n=148) |
| Total bleeding AEs |
11 |
8 |
6 |
| Patients with ≥1 treatment-emergent bleeding AE, n (%) |
9 (2.8)a |
8 (5.6) |
4 (2.7)b |
| Risk ratio vs. placebo [95% CI] |
1.05 [0.33, 3.35]; p=0.93c |
2.08 [0.64, 6.77]; p=0.22c |
-- |
| Bleeding AEs by preferred term, n (%)d |
| Rectal hemorrhage |
2 (0.6) |
2 (1.4) |
0 |
| Incision site hematoma |
0 |
3 (2.1) |
0 |
| Vaginal hemorrhage |
1 (0.3) |
0 |
2 (1.4) |
| Epistaxis |
2 (0.6) |
0 |
0 |
| Eye hemorrhage |
0 |
1 (0.7) |
0 |
| Hemarthrosis |
1 (0.3) |
0 |
0 |
| Hematemesis |
0 |
0 |
1 (0.7) |
| Hematocrit decreased |
0 |
0 |
1 (0.7) |
| Hematoma |
1 (0.3) |
0 |
0 |
| Hematuria |
1 (0.3) |
0 |
0 |
| Hemoptysis |
0 |
0 |
1 (0.7) |
| Hemorrhagic anemia |
1 (0.3) |
0 |
0 |
| Hemorrhagic ovarian cyst |
0 |
0 |
1 (0.7) |
| Periorbital hematoma |
0 |
1 (0.7) |
0 |
| Petechiae |
0 |
1 (0.7) |
0 |
| Total postoperative anemia AEs |
7 |
2 |
3 |
| Patients with postoperative anemia AE, n (%) |
7 (2.2) |
2 (1.4) |
3 (2.0) |
| Risk ratio vs. placebo [95% CI] |
1.09 [0.28, 4.14]; p=0.83c |
0.69 [0.12, 4.10]; p=0.76c |
-- |
aIncludes 1 patient with 2 epistaxis events and 1 patient with 2 vaginal hemorrhage events;
bIncludes 1 patient with 1 event each of hematemesis, hematocrit decreased, and hemoptysis;
cFrom Cochran–Mantel–Haenszel test comparing treatment and placebo;
dn (%) represents number and percentage of patients with a given bleeding AE. |
