User Manual

Lumax Technical Manual 53
The analysis of the primary effectiveness endpoint is an intention-
to-treat analysis based on the responder classification of changes
in the MLWHFQ and 6-minute walk distance between periods of
SIM and OPT, obtained at the 1-month and 2-month follow-ups.
Table 20
presents the percentage of all patients worsened and
not worsened to evaluate the effectiveness of OPT vs. SIM
utilizing the QOL and 6-minute walk responder classification. A
total of 106 out of the 110 patients that completed the primary
endpoint follow-up met the primary endpoint analysis based on
paired QOL and 6-minute walk data at the 1-month and 2-month
follow-up visits.
Table 19. QOL and 6-Minute Walk Test Results (Effectiveness)
Category Group 1 Group 2
QOL score at baseline
N = 60
35.4 ± 23.0
N = 53
30.0 ± 21.6
QOL score at 1-month
follow-up
N = 57
31.2 ± 24.0
OPT
N = 54
30.1 ± 22.5
SIM
QOL score at 2-month
follow-up
N = 58
32.6 ± 25.5
SIM
N = 52
25.9 ± 19.8
OPT
Distance walked at
baseline (m)
N = 61
328.9 ± 152.8
N = 54
309.1 ± 139.7
Distance walked at 1-
month follow-up (m)
N = 58
343.9 ± 161.8
OPT
N = 54
337.6 ± 160.7
SIM
Distance walked at 2-
month follow-up (m)
N = 57
341.1 ± 152.6
SIM
N = 51
334.7 ± 148.9
OPT