User Manual Part 2

C-4
CLINICAL STUDY - MADIT II
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)
Angina pectoris
166 (110) 10.0 (73) 0.8 (112) 6.0 (44) 0.4 (54)
Bradycardia, sinus
8 (8) 1.0 ( 7) 0.1 (7) 0.1 (1) 0.0 (1)
Tachycardia
7 (7) 0.3 ( 2) 0.0 (2) 0.7 (5) 0.0 (5)
AV Block,
Complete
1 (1) 0.1 ( 1) 0.1 (1) 0.0 (0) 0.0 (0)
Cardiac allograft
rejection
2 (2) 0.3 ( 2) 0.0 (2) 0.0 (0) 0.0 (0)
Hypotension
28 (26) 1.4 (10 ) 0.1 (10) 2.2 (16) 0.1 (18)
Hypertension
6 (6) 0.1 ( 1) 0.0 (1) 0.7 (5) 0.0 (5)
Claudication 10 (7) 0.8 (6) 0.1 (9) 0.1 (1) 0.0 (1)
Carotid stenosis 5 (5) 0.5 ( 4) 0.0 (4) 0.1 (1) 0.0 (1)
Aneurysm
1 (1) 0.1 ( 1) 0.0 (1) 0.0 (0) 0.0 (0)
Deep vein
thrombosis
9 (9) 1.0 ( 7) 0.1 (7) 0.3 (2) 0.0 (2)
Pulmonary
Embolus
4 (4) 0.5 ( 4) 0.0 (4) 0.0 (0) 0.0 (0)
Individual events
that occurred o ne
time
5 (5) 0.5 ( 4) 0.0 (4) 0.1 (1) 0.0 (1)
Subtotal
Cardiovascular
Related Events:
ICD Therapy
(treatment group)
956 (354) 36.8 (269) 4.6 (637) 26.8 (196) 2.3 (319)
Cardiovascular Related Events (n=476 pts): Conventional Therapy (control group)
Arrhythm ia, atrial
31 (29) 3.2 (15 ) 0.2 (16) 3.2 (15) 0.2 (15)
Arrhythm ia,
ventricular
33 (26) 4.6 (22 ) 0.3 (27) 1.1 (5) 0.1 (6)
Arrhythm ia,
general report
3 (3) 0.4 ( 2) 0.0 (2) 0.2 (1) 0.0 (1)
Mitral valve
regurgitation
1 (1) 0.2 ( 1) 0.0 (1) 0.0 (0) 0.0 (0)
Congestive heart
failure
212 (128) 16.6 (79) 1.5 (126) 14.3 (68) 1.0 (86)
- DRAFT -