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)
Percent of Subjects
(n/N)
Burst stimulation-related
Diminished or loss of stimulation* 4 3
†
3.00% (3/100)
a
Diminished or loss of symptom
relief*
5 5 5.00% (5/100)
a
Unpleasant sensations** 4 4 4.00% (4/100)
a
Tonic stimulation-related
Diminished or loss of stimulation* 2 2 2.06% (2/97)
b
Diminished or loss of symptom
relief*
8 6
†
6.19% (6/97)
b
Stimulation in wrong place** 5 4
†
4.12% (4/97)
b
Unpleasant sensations** 1 1 1.03% (1/97)
b
Total 29 16
‡
16.00% (16/100)
* 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)
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