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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 3 for complete details.
Table 3. ACT1 Incidence of Adverse Events and Adverse Device Effects (All Treated Subjects)
Double-blind
Open-label
Phase Phase
nVNS Sham
nVNS
AEs and ADEs
(n=73) (n=77)
(n=128)
Subjects with ≥1 AE, No. (%)
18 (24.7)
31 (40.3)
42 (32.8)
Subjects with ≥1 serious AE, No. (%)
1 (1.4)
a,b
0
5 (3.9)
b,c
Subjects with ≥1 ADE, No. (%)
11 (15.1)
24 (31.2)
18 (14.1)
ADEs Occurring in ≥5% of subjects in Any Treatment Group, No. (%)
Application site reactions
Burning/tingling/soreness/stinging
2 (2.7)
7 (9.1)
4 (3.1)
Skin irritation/redness/erythema
0
9 (11.7)
2 (1.6)
Musculoskeletal disorders
Lip or facial drooping/pulling/twitching
8 (11.0)
0
9 (7.0)
Nervous system disorders
Dysgeusia/metallic taste
0
7 (9.1)
2 (1.6)
Abbreviations: ADE, adverse device effect; AE, adverse event; nVNS, non-invasive vagus nerve stimulation.
a
Serious AE of cluster headache (2 occurrences).
b
Serious AEs were not considered related to the study device.
c
Serious AEs included cluster headache (1 occurrence; 1 subject); cluster headache as well as multiple left-extremity
deep vein thromboses, abdominal aortic aneurysm, pneumonia, anasarca, acute respiratory failure, and urethral
trauma (1 occurrence each in the same subject); mesenteric ischemia (1 occurrence; 1 subject); herniated disk
(1 occurrence; 1 subject); and ureteral calculus (1 occurrence; 1 subject).
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