User Manual Part 4

CLINICAL STUDY - COMPANION
B-21
1080 960 840 720 600 480 360 240 120 0
100
80
60
40
20
0
% of Patients Event-Free
Days from Randomization
All-cause Mortality or First Hospitalization
CRT-D vs. OPT: p = 0.010
Number of Events
OPT: 216
CRT-D: 390
OPT
CRT-D
308
595
Number of
Patients at Risk
OPT
CRT-D
176
385
115
283
72
217
46
128
24
61
16
25
6
8
1
0
HR = 0.80. 95% CI (0.68, 0.95)
Figure B-4. Primary Endpoint: All-cause mo rtalit y or first hosp italiz at ion
In addition to the hazard ratio, point estimates o f risk reduction were also
calculated (Table B-7 on page B-21). These estimates will vary with time from
the true treatment effect, and thus should be interpreted with caution.
Table B-7. Risk reduction point estimates
% Failure
Absolute Risk
Reduction
Relative Risk
Reduction
OPT CRT-D
6months
44.9%
(38.9%, 50.3%)
42.9%
(38.7%, 46.7%)
2.0% 4.5%
12 months
68.0%
(61.7%, 73.2%)
55.9%
(51.6%, 59.8%)
12.1% 17.8%
18 months
77.8%
(71.6%, 82.7%)
69.0%
(64.5%, 73.1%)
8.8% 11.3%
Secondary Endpoints
All-cau se Mortality––deaths from any cause w ere reported in 77 patients
randomized to OPT and 105 patients randomized to CRT-D (p = 0.003, p
= 0.004 after adjusting for interim analyses). The Kaplan-Meier curves are
- DRAFT -