User Manual

6. CLINICAL STUDIES
Six-month system complication-free rate
Number of patients
contributing to analysis
Kaplan-Meier six-month
complication-free estimate
One-sided lower 95%
confidence bound for six-
month complication-free
estimate
190 89.5 % 84.1 %
6.1.4 . Absolute Differences in Peak VO
2
and QOL
The tables below show the absolute differences between the control and test groups’ peak
VO
2
and QOL over the 6 month follow-up period in the clinical trial.
Absolute difference between test and control groups’ change in peak V0
2
over 6 months
Baseline
Mean ± SD
(range)
6-month
Mean ± SD
(range)
Difference
within group
Difference
between
groups
Change in
Peak VO2
(mL/min/Kg)
Control group
(n=41)
13.39 ± 4.58
(5.02, 24.10)
13.12 ± 3.99
(3.30, 20.70)
- 0.28 1.85
Test group
(n=91)
11.84 ± 3.90
(3.50, 26.3)
13.41 ± 4.28
(6.18, 27.67)
1.57
Absolute difference between test and control groups’ change in QOL score over 6 months
Baseline
Mean ± SD
(range)
6-month
Mean ± SD
(range)
Difference
within group
Difference
between
groups
Change in QOL
Control group
(n=41)
47.5 ± 19.29
(9, 90.3)
31.21 ± 23.96
(0, 95)
16.29 1.28
Test group
(n=91)
52.81 ± 21.84
(9, 92)
35.24 ± 23.73
(0, 93)
17.57
The table below presents the percentage of patients in each group who improved,
worsened, or remained unchanged in each element of the composite score and the
composite score itself.
QOL score VO
2
Score Composite Score
Control
GROUP
Test GROUP Control
GROUP
Test GROUP Control
GROUP
Test GROUP
% Improved 75.6 74.7 48.8 67.0 62.2 70.9
% Worsened 24.4 25.3 51.2 31.9 37.8 28.6
%
Unchanged
0.0 0.0 0.0 1.1 0.0 0.0
Histograms for Respiratory Exchange Rate (RER) at peak VO
2
at baseline and 6 month
follow-up are provided below:
SORIN – INTENSIA SonR CRT-D 184 – U150A
17