35
64000-00120 Rev 3
Safety
gammaCore was found to be safe and well tolerated in this study. The majority of the adverse events
were mild and transient and occurred during the time of active treatment. None of the serious adverse
events were considered device related. Please see Table 6 for complete details.
Table 6. ACT2 Incidence of Adverse Events and Adverse Device Effects (All Treated Subjects)
Double-blind
Open-label
Phase Phase
nVNS Sham
nVNS
AEs and ADEs
(n=50) (n=52)
(n=83)
Subjects with ≥1 AE, No. (%)
23 (46.0)
22 (42.3)
28 (33.7)
Subjects with ≥1 serious AE, No. (%)
1 (2.0)
a
1 (1.9)
b
0
Subjects with ≥1 ADE, No. (%)
13 (26.0)
13 (25.0)
14 (16.9)
ADEs Occurring in ≥5% of subjects in any Treatment Group, No. (%)
No ADEs occurred in ≥5% of subjects in any treatment group
a
One subject in the gammaCore group reported severe lower abdominal and lower back pain. These events were
not considered related to treatment and resolved without intervention.
b
One subject in the sham group reported severe depression and anxiety. These events were not considered by the
investigator to be related to the sham device. The subject discontinued from the study, and the SAEs resolved.
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