User Manual Part 4

D-14
CLINICAL STU DY - CONTAK CD
inTable D-6 on page D-14. The Kaplan-Meier curve, showing total survival by
treatment group, is shown in Figure D-2 on page D-14.
TableD-6. Mortalitystratified by treatment grou p and cause
Deaths
a
Patients with CRT
(N = 245)
Patients with No CRT
(N = 245)
Cardiac, pump failure 4 (1.6%) 9 (3 .7%)
Cardiac, arrhythmic 1 (0.4%) 0 (0.0%)
Cardiac, other 2 (0.8%) 1 (0 .4%)
Noncardiac
2 (0.8%) 3 (1.2%)
Unknown
2 (0.8%) 3 (1.2%)
Tota l
11 (4.5%) 16 (6.5%)
a. All patients implanted and active at 31 days post-implant; N = 490.
630
100
95
90
85
0
Total Survival (%)
Time Post-randomization (Months)
No CRT
CRT
245
245
242
241
239
233
127
130
125
129
123
126
122
125
p = 0.32
CRT
No CRT
Patients at Risk
Figure D-2. Kaplan-Meier curve
Table D-7 on page D-15 presents the reasons for hospitalization within the
treatment period as determined by the Events Committee. This table represents
the number of patients with each category of hospitalization. Patients may have
multiple hospitaliz ation s that fall into different c ateg ories.
- DRAFT -