Abbott Proclaim 3660 Clinician Manual page 49

The following table identifies non-serious study-related AEs. Of all the stimulation-related non-
serious AEs, 13 occurred with burst stimulation and 16 occurred with tonic stimulation. Fewer
non-serious AEs were noted for burst stimulation mode than tonic stimulation mode.
Table 24. Summary of stimulation-related, nonserious AEs (activation to 24 weeks)
Event Description
Burst stimulation-related
Diminished or loss of stimulation*
Diminished or loss of symptom
relief*
Unpleasant sensations**
Tonic stimulation-related
Diminished or loss of stimulation*
Diminished or loss of symptom
relief*
Stimulation in wrong place**
Unpleasant sensations**
Total
* Undesirable changes in stimulation
** Unintended effects of stimulation
†
Some subjects experienced more than one event; therefore, the number of subjects
experiencing an event is not equal to the number of events in the neighboring column.
‡
The total number of subjects who experienced at least one event listed from the previous rows
a Subjects at risk out of the 55 subjects from the burst/tonic arm, as well as the 45 subjects from
the tonic/burst arm who completed the week-12 visit (when they crossed over to burst stimulation)
b
Subjects at risk out of the 45 subjects from the tonic/burst arm, as well as the 52 subjects from
the burst/tonic arm who completed the week-12 visit (when they crossed over to tonic stimulation)
Number of Number of
Events Subjects
4
5
4
2
8
5
1
29 16
45
Percent of Subjects
(n/N)
3 † 3.00% (3/100)
5 5.00% (5/100)
4 4.00% (4/100)
2 2.06% (2/97)
6 † 6.19% (6/97)
†
4 4.12% (4/97)
1 1.03% (1/97)
‡ 16.00% (16/100)
a
a
a
b
b
b
b