Table 2.
Summary of adverse events—by type of surgery.
| TKR (N = 326) | THR (N = 172) | |
|---|---|---|
| Primary endpoint: ISTH-defined major and CRNM bleeding | 0 | 1 (Moderate incision-site hemorrhage a ) |
| Bleeding AEs | ||
| Not related | 3 (2 mild decreased hemoglobin; 1 mild hematuria) | 1 (Moderate incision-site hemorrhage a ) |
| Related to study drug | 0 | 2 (1 Mild serosanguinous wound discharge; 1 moderate incision-site hemorrhage a ) |
| AEs leading to discontinuation | ||
| Not related | 1 (Mild pyrexia) | 0 |
| Related to study drug | 1 (Mild DVT—popliteal) | 2 (1 Mild serosanguinous wound discharge; 1 moderate incision-site hemorrhage a ) |
| Serious adverse events | ||
| Not related | 2 (1 mild anemia; 1 mild vertigo) | 0 |
| Related to study drug | 1 (Mild DVT—popliteal) | 0 |
| AEs | ||
| Not related | 132 (125 mild events; 6 moderate events; 1 severe event) | 34 (31 mild events; 3 moderate events) |
| Related to study drug | 4 (3 mild: DVT, incision site pain, urinary retention; 1 moderate: hypertension) | 2 (1 mild: serosanguinous wound discharge; 1 moderate: incision-site hemorrhage a ) |
TKR: total knee replacement; THR: total hip replacement; CRNM bleeding: clinically relevant nonmajor bleeding; DVT: deep vein thrombosis; AE: adverse event; ISTH: International Society on Thrombosis and Haemostasis.
a
This event was adjudicated as an ISTH-defined CRNM bleeding event.