Table 4.
Investigator's assessment of haemostatic efficacy of VONCENTO per bleeding event in arm 2 (on-demand) (efficacy population)
NSB events, N (%) | |||||
Bleeding type | NSB eventsa, N | Excellent | Good | Moderate | None |
All NSB events | 407 | 374 (92.1) | 25 (6.2) | 7 (1.7) | 0 |
Spontaneous | 403 | 371 (92.1) | 25 (6.2) | 7 (1.7) | 0 |
Trauma | 3 | 3 (100.0) | 0 | 0 | 0 |
Postsurgery | 1 | 1 (100.0) | 0 | 0 | 0 |
Majorb | 125 | 117 (93.6) | 2 (1.6) | 6 (4.8) | 0 |
Minor | 281 | 257 (91.5) | 23 (8.2) | 1 (0.3) | 0 |
Jointc | 101 | 99 (98.0) | 2 (2.0) | 0 | 0 |
Mucosalb,c | 290 | 260 (89.7) | 23 (7.9) | 7 (2.4) | 0 |
Muscle | 17 | 17 (100.0) | 0 | 0 | 0 |
N, number of events; NSB, nonsurgical bleeding.
aNSB events treated with VONCENTO and with a haemostatic efficacy assessment.
bIncludes seven major mucosal events.
cTwo bleeding events of one study participant were each counted in both body location categories ‘joint’ and ‘mucosal’.