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.
Table 3: Summary of bleeding adverse events by severity and relationship to treatment. AE = Adverse Event.