User Manual Part 4

CLINICAL STUDY - COMPANION
B-31
Patient Accountability (Figure B-12 on page B-31)
OPT
Baseline Visit
87
Peak VO
2
Assessable for
effectiveness
46
6MW
Assessable for
effectiveness
57
Patient related
Crossover
Withdrawn
Death
Other
11
6
4
10
10
6
5
4
10
5
Peak VO
2
Assessable for
effectiveness
231
6MW
Assessable for
effectiveness
261
Patient related
Mode Change
Withdrawn
Death
Other
28
20
16
2
21
24
12
16
2
3
CRT
Baseline Visit
318
Randomized
448
Met Exclusion Criteria 6
Intent/Attempt 37
Figure B-12. Enrollment and follow-up o f randomized patients
Baseline Characteristics— (Table B-10 on page B-31)
Table B-10. Patient population characteristics
Characteristic CRT
(N = 318)
OPT
(N = 87)
P-value
a
Age (years) Mean ± SD
62.1 ± 11.8 63.1 ± 10.6 0.48
Range 32.0–86.0 27.0–85.0
Gender [N (%)]
Female
109 (34.3) 24 (27.6)
0.24
Male
209 (65.7) 63 (72.4)
NYHA Classification [N (%)]
III
294 (92.5) 79 (90.8)
0.61
IV
24 (7.5) 8 (9.2)
- DRAFT -