TABLE 3.
Number of bleeds recorded during compassionate use by treatment group (on‐demand or routine prophylaxis)
| Patient number | No. of bleeds | Severity | Cause | Location | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Minor | Major | Not recorded | Spontaneous | Traumatic | Menorrhagia | Other | Unknown | Joint | Muscle | Mucosal/menorrhagic | Mucosal/nonmenorrhagic | Other | Unknown | ||
| Routine prophylaxis | |||||||||||||||
| 1 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| 2 | 4 | 4 | — | — | 4 | — | — | — | — | — | — | — | 1 | 3 a | — |
| 3 | 8 | 7 | 1 | — | 2 | 6 | — | — | — | 6 | 2 | — | — | — | — |
| 4 | 2 | 1 | 1 | — | 2 | — | — | — | — | — | — | — | 1 | 1 b | — |
| 5 c | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| 6 | 3 | 1 | 1 | 1 | — | — | 1 | 2 d | — | — | — | 1 | — | 2 | — |
| 7 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| 8 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| On demand | |||||||||||||||
| 9 | 2 | 1 | — | 1 | 1 | 1 | — | — | — | 1 | 1 | — | — | — | — |
| 10 | 7 | 6 | 1 | — | 3 | 3 | — | — | 1 | 4 | 2 | — | 1 | — | — |
| 5 c | 6 | 5 | 1 | — | 2 | 4 | — | — | — | 1 | 1 | — | 2 | 2 e | — |
| 11 | 5 | — | — | 5 | — | — | 5 | — | — | — | — | 5 | — | — | — |
| 12 | 5 | — | — | 5 | — | — | 3 | 1 f | 1 | — | 1 | 3 | — | — | 1 |
| 13 | 9 | — | — | 9 | — | 4 | 5 | — | — | — | — | 5 | — | 4 g | — |
| 14 | 11 | 9 | 2 | — | 1 | 10 | — | — | — | 4 | 5 | — | — | 1 h | 1 |
| 15 | 26 | — | — | 26 | 2 | — | 23 | 1 i | — | — | — | 23 | 3 | — | — |
a
Subcutaneous for all.
b
Left arm soft tissue.
c
Patient 5 alternated between on‐demand treatment and routine prophylaxis. All 6 bleeds reported for this patient occurred during on‐demand treatment.
d
Miscarriages.
e
Subdural hematoma and external ear.
f
Cut on right arm.
g
Left or right leg for all.
h
Renal hemorrhage.
i
Postpartum.