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.
Table 2: Summary of treatment-emergent bleeding-related adverse events in the study population. AE = adverse event; CI = confidence interval.