Page 25 - Roche Hemlibra Non-inhibitors - Product Monograph

HAVEN 1–4: bleed rates

Model-based ABR* Treated bleeds over time

Proportion of participants with 0 or 1-3
Treated bleeds: traeted bleeds over time (n=400)
1.5 (95% CI, 1.20-1.84) 0 bleeds 1-3 bleeds

100 18.6 14.4 11.4
90
Percentage of participants 50
Spontaneous bleeds: 80 22.5 79.4 82.7 88.6
70
0.6 (95% CI, 0.5-0.8) 60 70.8

40

20
Joint bleeds: 30
1.0 (95% CI, 0.8-1.3) 10
00
1-24 weeks 25-48 weeks 49-72 weeks 73-96 weeks
n 391 354 284 114

* Calculated using negative binomial regression over a median of 83 weeks’ duration of exposure.

HAVEN 1–4: joint and spontaneous bleeds over time

Proportion of participants with 0 or 1-3 Proportion of participants with 0 or 1-3
joints bleeds over time (N=400) spontaneous bleeds over time (N=400)

0 bleeds 1-3 bleeds 0 bleeds 1-3 bleeds
7.4
3.5
100 17.4 11.9 10.2 90.4 100 13.8 92.1 92.6 96.5
7.3
9.6
90
90
Percentage of participants 70 77.7 Percentage of participants 70
80
80
88.0
87.3
84.1
60
60
50
50
40
40
30
20
20
10 30
10
0 0
1-24 weeks 25-48 weeks 49-72 weeks 73-96 weeks 1-24 weeks 25-48 weeks 49-72 weeks 73-96 weeks
n 391 354 284 114 n 391 354 284 114

HEMLIBRA Monograph-Non-inhibitors | 23
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