Table 2.
Occurrence of bleeding events (safety analysis set).
| Number of patients, n (%) | Treatment regimen | |||
|---|---|---|---|---|
| Prophylaxis | On-demand | Unknown | No aPCC | |
| With any bleeding event | 31 (81.6) | 10 (83.3) | 0 (0.0) | 1 (50.0) |
| With any treated bleeding event | 26 (68.4) | 9 (75.0) | 0 (0.0) | 0 (0.0) |
| With any spontaneous bleeding event | 21 (55.3) | 9 (75.0) | 0 (0.0) | 0 (0.0) |
| With any injury/traumatic bleeding event | 23 (60.5) | 8 (66.7) | 0 (0.0) | 1 (50.0) |
| With any undetermined cause of bleeding event | 18 (47.4) | 5 (41.7) | 0 (0.0) | 1 (50.0) |
aPCC, activated prothrombin complex concentrate.
Any bleeding event includes breakthrough bleeding events. A treated bleeding event is defined as an event with a documented on-demand treatment administered within 72 h after the start of the event. The number of bleeds was calculated for each regimen; therefore, patients who switched regimens can appear more than once. Only patients with regimen duration of ⩾90 days are included in this analysis.