User's Manual

6. CLINICAL STUDIES
Pe*N Number of successes 35
Pe Observed experimental
proportion
0.95
Ps Null hypothesis success rate 0.76
ES Estimated standard error of Pe 0.04
z´ Test statistic
(1)
4.75
p Associated p-value < 0,0001
(1) Statistical test: z´ = (Pe-Ps)/SE where SE = sqrt(Pe(1-Pe)/N)
6.1.2. Rate response
European patients only:
GROUP Number of
patients
included
Mean slope
%SRR on
%MR
STD of
slopes
%SRR on
%MR
SE of mean
slope %SRR
on %MR
Lower 95%
CI
Upper 95%
CI
Europe 20 0.77 0.17 0.04 0.69 0.84
Small
Centers
9 0.79 0.18 0.06 0.67 0.91
Large
Centers
11 0.75 0.15 0.05 0.66 0.84
Males 17 0.77 0.16 0.04 0.70 0.85
Females 3 0.73 0.22 0.13 0.47 0.98
SRR: Sensor Rate Reserve
MR: Metabolic Reserve
STD: Standard Deviation
SE: Standard Error
CI: Confidence Interval
6.1.3. Adverse events
Event US (N=22) Number of events* Number of patients Percent of patients
Intent to treat but did
not
0 0 0.0
Non-device related
death
0 0 0.0
Explant 0 0 0.0
Complication 0 0 0.0
Observation 0 0 0.0
Serious non-related
other than death
1 1 4.5
SORIN – PLATINIUM DR – U460A
17