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Table 21: Adjudicated Serious Adverse Events, Day 0-168: ITT Population
FIX-HF-5C2 OPTIMIZER
FIX-HF-5C OPTIMIZER
FIX-HF-5C Control
Variable
# Events
Subjects
2
# Events
Subjects
P-value
1
# Events
Subjects
P-value
1
All
26
19 (31.7%)
29
20 (27.0%)
0.572
27
19 (22.1%)
0.250
(20.3%, 45.0%)
(17.4%, 38.6%)
(13.9%, 32.3%)
General Medical
8
7 (11.7%)
7
7 (9.5%)
0.779
8
7 (8.1%)
0.571
(4.8%, 22.6%)
(3.9%, 18.5%)
(3.3%, 16.1%)
Arrhythmia
3
2 (3.3%)
3
3 (4.1%)
1.000
2
2 (2.3%)
1.000
(0.4%, 11.5%)
(0.8%, 11.4%)
(0.3%, 8.1%)
Worsening Heart Failure
7
5 (8.3%)
4
3 (4.1%)
0.466
8
7 (8.1%)
1.000
(2.8%, 18.4%)
(0.8%, 11.4%)
(3.3%, 16.1%)
General Cardiopulmonary
2
2 (3.3%)
4
3 (4.1%)
1.000
2
2 (2.3%)
1.000
(0.4%, 11.5%)
(0.8%, 11.4%)
(0.3%, 8.1%)
Bleeding
1
1 (1.7%)
0
0 (0.0%)
0.448
1
1 (1.2%)
1.000
(0.0%, 8.9%)
(0.0%, 4.9%)
(0.0%, 6.3%)
Neurologic
1
1 (1.7%)
0
0 (0.0%)
0.448
0
0 (0.0%)
0.411
(0.0%, 8.9%)
(0.0%, 4.9%)
(0.0%, 4.2%)
Thromboembolism
1
1 (1.7%)
1
1 (1.4%)
1.000
1
1 (1.2%)
1.000
(0.0%, 8.9%)
(0.0%, 7.3%)
(0.0%, 6.3%)
Local Infection
1
1 (1.7%)
1
1 (1.4%)
1.000
4
4 (4.7%)
0.649
(0.0%, 8.9%)
(0.0%, 7.3%)
(1.3%, 11.5%)
Sepsis
1
1 (1.7%)
1
1 (1.4%)
1.000
1
1 (1.2%)
1.000
(0.0%, 8.9%)
(0.0%, 7.3%)
(0.0%, 6.3%)
ICD or Pacemaker System
Malfunction
1
1 (1.7%)
2
2 (2.7%)
1.000
0
0 (0.0%)
0.411
(0.0%, 8.9%)
(0.3%, 9.4%)
(0.0%, 4.2%)
OPTIMIZER System Malfunction
0
0 (0.0%)
6
6 (8.1%)
0.033
-
(0.0%, 6.0%)
(3.0%, 16.8%)
Program Name: AE.sas
1
Compared to FIX-HF-5C2 OPTIMIZER Group via Fishers exact test.
2
Number and percent of subjects. Subjects are counted only once within each category.