Use Instructions

64
Adverse Events
All site reported non-serious adverse events and adjudicated serious adverse events
from study start date to 24 weeks; are tabulated in Table 21 and Table 22 in the ITT
population. The total number of events and the number and percent of subjects having at
least one event of the type listed is given. Event rates were similar to those seen in both
the FIX-HF-5C OPTIMIZER and control groups. At a nominal 0.05 level of significance,
there were fewer percentage of subjects that had a serious OPTIMIZER System
malfunction in the FIX-HF-5C2 study than in the previous study (p=0.03).