User Manual Part 2

CLINICAL STUD Y - MADIT II
C-3
Table C-1. Adverse events through the ran do mization period (continued)
Adverse Event
# Of Events
(# of pts)
a
%
Complications
(Patients)
Complications
per 100
Device Months
(Events)
%
Observations
(Patients)
Observations per
100 Device Months
(Events)
Subtotal Device
Related Events
132 (91
a
) 2.9 (35 ) 0.2 (37) 4.9 (59) 0.4 (95)
Procedure Related Events
b
Infection 13 (13) 0.8 (9) 0.0 (9) 0.3 (4) 0.0 (4)
Lead problem
2 (2) 0.1 ( 1) 0.0 (1) 0.1 (1) 0.0 (1)
Patient bleeding
2 (2) 0.1 ( 1) 0.0 (1) 0.1 (1) 0.0 (1)
Pulse generator
flipped (Twiddler)
2 (2) 0.0 ( 0) 0.0 (0) 0.2 (2) 0.0 (2)
Pocket
inflammation/hematoma
15 (15) 0.9 (11) 0 .0 (11) 0.3 (4) 0.0 (4)
Pain
10 (10) 0.1 (1) 0.0 (1) 0.7 (9) 0.0 (9)
Fibrillation, atrial
2 (2) 0.0 ( 0) 0.0 (0) 0.2 (2) 0.0 (2)
Deep Vein
Thrombosis
3 (3) 0.1 ( 1) 0.0 (1) 0.2 (2) 0.0 (2)
Anxiety
2 (2) 0.0 ( 0) 0.0 (0) 0.2 (2) 0.0 (2)
Individual events
that occurred o ne
time
17 (17) 0.8 (8) 0.0 (8) 0.9 (9) 0.0 (9)
Subtotal
Procedure Related
Events
68 (59
a
) 2.2 (26) 0.1 (32) 3.0 (36) 0.2 (36)
Cardiovascular Related Events (n=730 pts): ICD Therapy (treatment group)
Arrhythm ia, atrial
78 (66) 4.2 (31 ) 0.2 (34) 5.3 (39) 5.3 (39)
Arrhythm ia,
ventricular
64 (49) 5.3 (39 ) 0.4 (53) 1.4 (10) 0.1 (11)
Mitral valve
regurgitation
1 (1) 0.1 ( 1) 0.0 (1) 0.0 (0) 0.0 (0)
Congestive heart
failure
444 (227) 22.9 (167) 2.2 (304) 14.1 (103) 1.0 (140 )
Palpitation,
pounding heart
21 (18) 1.0 (7) 0.1 (7) 1.5 (11) 0.1 (14)
Syncope 62 (50) 4.7 (34 ) 0.3 (40) 2.5 (18) 0.2 (22)
Infarction,
myocardial
34 (28) 3.8 (28 ) 0.2 (34) 0.0 (0) 0.0 (0)
- DRAFT -