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Table 4 Overview of adverse events (safety set)

From: Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial

 

1 Hz (n = 22)

25 Hz (n = 24)

 

Number of events

Number of patients (%)

Number of events

Number of patients (%)

Treatment emergent AEs

67

17 (77.3 %)

112

19 (79.2 %)

Treatment-related AEs

39

11 (50.0 %)

76

17 (70.8 %)

Stimulation site treatment-related TEAEs

31

10 (45.5 %)

70

17 (70.8 %)

All serious AEs (including pre-treatment SAEs)

2

2 (9.1 %)

0

0

Serious treatment emergent AEs

2

2 (9.1 %)

0

0

Serious treatment-related AEs

0

0

0

0

Treatment-related AEs leading to discontinuation of study

8

4 (18.2 %)

4

1 (4.2 %)

Death

0

0

0

0