Use Instructions

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Table 22: Non-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
39
26 (43.3%)
41
21 (28.4%)
0.101
35
23 (26.7%)
0.050
(30.6%, 56.8%)
(18.5%, 40.1%)
(17.8%, 37.4%)
General Medical
23
19 (31.7%)
22
14 (18.9%)
0.108
23
13 (15.1%)
0.025
(20.3%, 45.0%)
(10.7%, 29.7%)
(8.3%, 24.5%)
Arrhythmia
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%)
Worsening Heart Failure
3
3 (5.0%)
6
5 (6.8%)
0.731
4
4 (4.7%)
1.000
(1.0%, 13.9%)
(2.2%, 15.1%)
(1.3%, 11.5%)
General Cardiopulmonary
4
4 (6.7%)
3
3 (4.1%)
0.700
3
3 (3.5%)
0.446
(1.8%, 16.2%)
(0.8%, 11.4%)
(0.7%, 9.9%)
Bleeding
2
2 (3.3%)
2
2 (2.7%)
1.000
0
0 (0.0%)
0.167
(0.4%, 11.5%)
(0.3%, 9.4%)
(0.0%, 4.2%)
Neurologic
0
0 (0.0%)
1
1 (1.4%)
1.000
0
0 (0.0%)
(0.0%, 6.0%)
(0.0%, 7.3%)
(0.0%, 4.2%)
Thromboembolism
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%)
Local Infection
5
5 (8.3%)
3
3 (4.1%)
0.466
1
1 (1.2%)
0.043
(2.8%, 18.4%)
(0.8%, 11.4%)
(0.0%, 6.3%)
Sepsis
0
0 (0.0%)
0
0 (0.0%)
0
0 (0.0%)
(0.0%, 6.0%)
(0.0%, 4.9%)
(0.0%, 4.2%)
ICD or Pacemaker System
Malfunction
0
0 (0.0%)
0
0 (0.0%)
0
0 (0.0%)
(0.0%, 6.0%)
(0.0%, 4.9%)
(0.0%, 4.2%)
OPTIMIZER System Malfunction
0
0 (0.0%)
3
2 (2.7%)
0.502
-
(0.0%, 6.0%)
(0.3%, 9.4%)
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.