User Manual Part 3

CLINICAL STUDY - COMPANION
B-7
Table B -2. Patien t-related adv erse events (continued)
Total Events (Patients) % of Patients with
Events
Events/Patient Yea r
CRT-D OPT CRT-D
N=595
Patients
OPT
N=308
Patients
CRT-D
281 Years
OPT
134 Years
Vascular
14 (11) 11 (10)
1.8 3.2
0.05 (14) 0 .08 (11)
Syncope 12 (12) 7 (7)
2.0 2.3
0.04 (12) 0.05 (7)
GI bleed 14 (13) 4 (4)
2.2 1.3
0.05 (14) 0.03 (4)
Arrhythmia
12 (10) 6 (6)
1.7 1.9
0.04 (12) 0.04 (6)
Hypertension
12 (9) 6 (5)
1.5 1.6
0.04 (12) 0.04 (6)
Palpitations
9(9) 3(3)
1.5 1.0
0.03 (9) 0.02 (3)
Myocardial infarction 7 (7) 4 (4)
1.2 1.3
0.02 (7) 0.03 (4)
Stroke syndrome o r CVA 7 (7) 2 (2)
1.2 0.6
0.02 (7) 0.01 (2)
Deep vein thrombosis
4(4) 0(0)
0.7 0.0
0.01 (4) 0.00 (0)
Tr ansient ischemic attack
(TIA)
3(3) 1(1)
0.5 0.3
0.01 (3) 0.01 (1)
Hematuria
3(3) 0(0)
0.5 0.0
0.01 (3) 0.00 (0)
Ischemia
2(2) 1(1)
0.3 0.3
0.01 (2) 0.01 (1)
Coagulopathy 2 (2) 0 (0)
0.3 0.0
0.01 (2) 0.00 0(0)
Bleeding/fluid accumulation 1 (1) 0 (0)
0.2 0.0
0.00 (1) 0.00 (0)
Non-cardiovascular Related
Events
623 (293) 226 (119)
49.2 38.6
2.22 (623) 1.69 (226)
Respiratory related
b
130 (108) 53 (41)
18.2 13.3
0.46 (130) 0.40 (53)
GI
c
124 (95) 30 (24)
16.0 7.8
0.44 (124) 0.22 (30)
Pain
82 (66) 40 (32)
11.1 10.4
0.29 (82) 0.30 (40)
Physiological rea ction
d
76 (61) 20 (18)
10.3 5.8
0.27 (76) 0.15 (20)
Infection 54 (37) 18 (15)
6.2 4.9
0.19 (54) 0.13 (18)
Endocrine
41 (35) 16 (14)
5.9 4.5
0.15 (41) 0.12 (16)
Psychological effects 24 (19) 13 (12)
3.2 3.9
0.09 (24) 0.10 (13)
Change in physical status 20 (18) 9 (9)
3.0 2.9
0.07 (20) 0.07 (9)
Physical trauma
26 (22) 4 (4)
3.7 1.3
0.09 (26) 0.03 (4)
Neurologic
14 (14) 6 (6)
2.4 1.9
0.05 (14) 0.04 (6)
Genitourinary 9 (7) 5 (4)
1.2 1.3
0.03 (9) 0.04 (5)
Cancer, other 5 (5) 6 (5)
0.8 1.6
0.02 (5) 0.04 (6)
- DRAFT -