US Food and Drug Administration (FDA) Action Letter on Ximelagatran.
| Safety Concerns . | Efficacy Concerns . |
|---|---|
| Elevated hepatic enzymes | Clinical significance of endpoints (orthopedic surgery) |
| Increased risk for coronary events (orthopedic surgery) | Choice of comparator (EXULT orthopedic surgery trials, THRIVE IIII secondary VTE prevention trial) Choice of non-inferiority margin (SPORTIF program in atrial fibrillation) Validity of SPORTIF III results in atrial fibrillation (open label trial) |
| Safety Concerns . | Efficacy Concerns . |
|---|---|
| Elevated hepatic enzymes | Clinical significance of endpoints (orthopedic surgery) |
| Increased risk for coronary events (orthopedic surgery) | Choice of comparator (EXULT orthopedic surgery trials, THRIVE IIII secondary VTE prevention trial) Choice of non-inferiority margin (SPORTIF program in atrial fibrillation) Validity of SPORTIF III results in atrial fibrillation (open label trial) |