HPβCD-diclofenac (n=60) Ketorolac (n=29) Placebo (n=35)
Patients receiving anticoagulantsa,b
Total bleeding AEs 4 2 0
Patients with ≥1 treatment-emergent bleeding AE, n (%) 3 (5.0) 2 (6.9) 0
Bleeding AEs by preferred term, n (%)
Epistaxis 1 (1.7)c 0 0
Hematuria 1 (1.7) 0 0
Incision site hematoma 0 1 (3.4)c 0
Rectal hemorrhage 1 (1.7) 1 (3.4) 0
aIncludes heparin and vitamin K antagonists (Coumadin/warfarin);
bFor patients receiving any medication with potential anticoagulant effects (includes acetic acid derivatives and related substances, heparin, other antithrombotics, oxicams, platelet aggregation inhibitors, propionic acid derivatives, salicylic acid and derivatives, vitamin K antagonists), incidences of bleeding AEs were 3.6% (n=5/138), 4.2% (n=3/71), and 1.5% (n=1/67) for the HPβCD-diclofenac, ketorolac, and placebo groups, respectively;
cIncludes 1 patient with two separate AEs of epistaxis;
dAE judged by investigator to be related to treatment
Table 4: Summary of bleeding adverse events in patients receiving anticoagulants. AE = adverse event.