User Manual Part 4

CLINICAL STUDY - COMPANION
B-17
account for patients that had a hospitalization or death event that contributed to
the primary endpoint or secondary endpoint of all-cause mortality.
Table B- 6. Patient follow-up dis position 12 months p ost-randomization
CRT-D OPT
#of
Withdrawn
Patients
#of
Deceased
Patients
(N =
595) #
Reached
end of
study
(Nov. 3 0,
2002)
#of
Active
Patients
at en d
of time
interval
#of
Withdrawn
Patients
#of
Deceased
Patients
(N = 308)#
Reached
end of
study
(Nov. 30,
2002)
#of
Active
Patients
at en d
of time
interval
1Day-
7Days
4 3 0 588 6 0 0 302
7Days-
1 Month
43
5
576 10 3 1 288
1Month-
3 Months
4 15 6 551 11 11 1 265
3 Months
-
9 Months
12 28 49 462 26 22 29 188
9 Months
-12
Months
1 12 35 414 11 11 19 147
- DRAFT -