Page 30 - Roche Hemlibra Non-inhibitors - Product Monograph

• For the ‘physical health’ score subscale, a ≥10-point change from baseline was considered
clinically meaningful

• The proportion of missed work days was also collected
• The schedule of assessments for the Haem-A-QoL and the missed work day item for HAVEN 3
and HAVEN 4 (expansion cohort only) included: Weeks 1, 13, 25, 49, 61 (HAVEN 4 only), 73
(HAVEN 3 only), and study completion

Haem-A-QoL* physical health score

HAVEN 3 HAVEN 4

100 100
80 80
Mean (SE) 60 38.8 25.6 29.5 26.8 27.7 Mean (SE) 60 47.7 30.3 32.4 27.4 26.4
40
40
20 20
0 0
Baseline† 13 25 49 73 Baseline† 13 25 49 61
n = 137 n = 132 n = 131 n = 129 n = 116 n = 137 n = 38 n = 37 n = 35 n = 35

Scores impoved by ≥10 points from baseline in Scores impoved by ≥10 points from baseline in
over 44% of participants in HAVEN 3 over 65% of participants in HAVEN 4

* Lower scores reflect better functioning; completed by participants aged ≥18 years only.
† Baseline assessment is the last valid assessment on or before study day 1.

Haem-A-QoL* total score

HAVEN 3 HAVEN 4

100 100
80 80
Mean (SE) 60 Mean (SE) 60 39.4

40 31.5
40
20 21.9 22.8 22.8 21.9 20 25.5 26.3 23.0 23.0
0 0
Baseline † 13 25 49 73 Baseline † 13 25 49 61
n = 137 n = 132 n = 131 n = 129 n = 116 n = 38 n = 38 n = 37 n = 35 n = 35
Week

Scores impoved from 31.5 at baseline to 22.8 at Scores impoved from 39.4 at baseline to 26.3 at
week 25 in Haven3, with improvements Week 25 in HAVEN $, with improvements
maintained throughout follow up maintainte throughout follow up

* Lower scores reflect better functioning; completed by participants aged ≥18 years only.
† Baseline assessment is the last valid assessment on or before study day 1.

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