User Manual Part 2

CLINICAL STUD Y - MADIT II
C-11
logarithmic transformation. The p-values were termed nominal when they were
not adjusted for sequential monitoring. All p-values were two-tailed.
At the re co mmendation of the Data and Safety Monitoring B oard (DSMB),
the trial was stopped on November 20, 2001, when it was revealed that the
difference in mortality between the two groups had reached the prespecified
efficacy boundary (p=0.027) (Figure C-2 on page C-11).
0 20 40 60 80
-10
0
10
20
Log-Rank
Statistic
Variance
Vlow = 11.72
Lower Boundary: -11.77 + 0.3819*V
x = 77.8
Upper Boundary: 11.77 + 0.1273*V
Nov. 13, 2001
Dec. 7, 2001
Figure C-2. Sequential monitoring in the triangular design
FOLLOW-UP SCHEDULE
Following randomization, patients were seen at a 1-month follow-up visit in the
clinic and at 3-month intervals thereafter until termination of the study. During
each clinic visit, an appropriate clinical evaluation was completed. Patients with
an ICD device underwent device testing according to an agreed-upon protocol
at the investigational center. Patients were followed from between 6 days and
53 months averaging 20 months.
- DRAFT -