Table 5.
Adverse events reported as "severe" by the authors versus our classification based on the Common Terminology Criteria for Adverse Events (CTCAE).
| Study | Device | Population | Number of SAEs | SAE from Active/Sham | Type | taVNS related | Grade 1,2 (not severe) | Grade 3 (hospitalization) | Grade 4 (life-threatening) | Grade 5 (death) |
|---|---|---|---|---|---|---|---|---|---|---|
| Evensen 2021 | NEMOS, Cerbomed | Depression | 1 | Active | Anxiety, worsening depression | Probably | 1 | |||
| Bauer 2016 | Epilepsy | 1 | 25 Hz(high level) | Suspected basal cell carcinoma | Probably or possibly | 1 | ||||
| 1 | 1 Hz(low level) | Sudden death | No | 1 | ||||||
| 1 | 25 Hz(high level) | Vestibular neuronitis | Probably or possibly | 1 | ||||||
| 1 | 1 Hz(low level) | Palpitation | Probably or possibly | 1 | ||||||
| Sabers 2021 | Epilepsy | 1 | Active | Unexpected death | No | 1 | ||||
| Kreuzer 2014 | Tinnitus | 1 | Active | Fireworks exposure | No | 1 | ||||
| 1 | Active | Elective bowel operation | No | 1 | ||||||
| Kreuzer 2012 | CM02, Cerbomed | Tinnitus | 1 | Active | Palpitation | No | 1 | |||
| Hasan 2015 | Schizophrenia | 1 | Active | Hospitalization | No | 1 | ||||
| 1 | Active | Appendectomy | No | 1 | ||||||
| 1 | Sham | Hospitalization | No | 1 | ||||||
| Stavrakis 2022 | The Parasym, Parasym | Heart failure | 1 | Active | Heart failure | No | 1 | |||
| 2 | Sham | Heart failure | No | 2 | ||||||
| 1 | Active | Persistent atrial fibrillation | No | 1 | ||||||
| 1 | Sham | Persistent atrial fibrillation | No | 1 | ||||||
| Peijing 2014 | TENS, Suzhou | Epilepsy | 1 | Active | Severe dizziness | Probably | 1 | |||
| Aihua 2014 | TENS-200, Suzhou | Epilepsy | 1 | Active | Severe dizziness | Probably | 1 | |||
| Early 2018 | n/a | Chronic Fatigue Syndrome | 1 | Active | Sensorineural hearing loss | No | 1 |
SAE: severe adverse events; n/a: non-applicable; Hz: hertz.