Safety profile
Demonstrated safety profile in the LEOPOLD clinical trial program
- 236 patients (193 PTPs, 43 PUPs/MTPs) constituted the pooled safety population in the three Phase III studies: Long-term Efficacy Open-Label Program in Severe Hemophilia A Disease (LEOPOLD) I, LEOPOLD II and LEOPOLD Kids1
- The most frequently reported adverse reactions were:1
- Pyrexia (9.3%)
- Headache (8.5%)
- Rash (5.5%)
