User Manual Part 2

C-12
CLINICAL STUDY - MADIT II
STUDY RESU LTS
Study Duration
Study duration, measured in months, is displayed in Table C-3 on page C-12.
The mean duration was similar between the ICD group and the conventional
therapy group. As expected, the ICD group accumulated >15,000 months
of follow-up.
Table C-3. Study duration in months
Therapy No. Mean
±SD
Minimum Maximum
Cumulative
ICD Therapy
742 20.5 12.9 0.2 51.7 15,190
Conventional Therapy
490 19.6 12.6 0.2 52.3 9,624
Demographic Data
Table C-4 on page C-12 provides a summary of the general characteristics of
the enrolled MADIT II patient population. Characteristics were balanced across
therapy g roups and no statistical differences were found during data analysis
as indicated by the p-values in the table.
Table C-4. Patient pop ulation characteristics
Characteristic ICD Patients
(n=742)
Conventional
Therapy Patients
(n=490)
p-value
Age at Enrollment
> 65 y ears (patients, %) 397 (53.5%) 262 (53.5%)
Mean ± Standard Deviation (years)
64.4 ± 10.4 64.6 ± 10.3
0.99
Gender (patients, % )
Male
623 (83.9%) 417 (85.1%)
0.59
LVEF (%)
Mean ± Standard Deviation
23.1 ± 5.4 23.2 ± 5.6 0.93
LVEF
a
≤ 25% (patients, %) 502 (76.7%) 330 (67.3%)
0.91
New York Heart Association Classification 3 months before enrollment (patients, %)
- DRAFT -