Table 2.
Total number of device- and procedure-related adverse device effects and total number and percentage of patients with adverse events throughout the study for each study group and for all the study groups combined
| AE category | Sham group | Gatekeeper group | Lead-in group | Total events (all) (n) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Events (n) | Patients (n) | Patients (n = 43) | Events (n) | Patients (n) | % of Patients (n = 75) | Events (n) | Patients (n) | % of Patients (n = 25) | ||
| Erosions over prostheses | 26 | 9 | 37.5a | 82 | 23 | 30.7 | 18 | 8 | 32.0 | 126 |
| Sore throat | 9 | 7 | 16.3 | 14 | 13 | 17.3 | 4 | 3 | 12.0 | 27 |
| Nausea/vomiting | 1 | 1 | 2.3 | 15 | 12 | 16.0 | 6 | 6 | 24.0 | 22 |
| Chest pain | 5 | 3 | 7.0 | 20b | 11 | 14.7 | 9 | 6 | 24.0 | 34 |
| Cough | 1 | 1 | 2.3 | 1 | 1 | 1.3 | 0 | 0 | 0.0 | 2 |
| Dysphagia | 3 | 2 | 8.3a | 10 | 7 | 9.3 | 1 | 1 | 4.0 | 14 |
| Epigastric pain | 1 | 1 | 2.3 | 8 | 5 | 6.7 | 2 | 2 | 8.0 | 11 |
| Odynophagia | 1 | 1 | 2.3 | 6 | 5 | 6.7 | 0 | 0 | 0.0 | 7 |
| Pulmonary infiltrate and pleural effusion | 0 | 0 | 0.0 | 1c | 1 | 1.3 | 0 | 0 | 0.0 | 1 |
| Prosthesis transmural migration | 1 | 1 | 4.2a | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 1 |
| Hemorrhage | 1 | 1 | 1.96 | 1 | 1 | 1.3 | 0 | 0 | 0.0 | 2 |
| Perforation | 0 | 0 | 0.0 | 1c | 1 | 1.3 | 1c | 1 | 4.0 | 2 |
| Desaturation | 1 | 1 | 2.3 | 1 | 1 | 1.3 | 1 | 1 | 4.0 | 3 |
| Bloating | 0 | 0 | 0.0 | 5 | 4 | 5.3 | 0 | 0 | 0.0 | 5 |
| Hiccough | 0 | 0 | 0.0 | 1 | 1 | 1.3 | 0 | 0 | 0.0 | 1 |
| Headache | 0 | 0 | 0.0 | 2 | 2 | 2.7 | 0 | 0 | 0.0 | 2 |
| Mouth injury or pain from overtube | 1 | 1 | 2.3 | 1 | 1 | 1.3 | 2 | 2 | 8.0 | 4 |
| Drowsiness | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 1 | 1 | 4.0 | 1 |
| Low-grade fever | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 1 | 1 | 4.0 | 1 |
| Deformed Anatomy at GE junction | 0 | 0 | 0.0 | 0 | 0 | 0.0 | 2 | 2 | 8.0 | 2 |
| Rash | 0 | 0 | 0.0 | 1 | 1 | 1.3 | 0 | 0 | 0.0 | 1 |
| Misreported AEsd | 1 | 1 | 2.3 | 1 | 1 | 1.3 | 2 | 1 | 4.0 | 4 |
| Total | 52 | 171 | 50 | 273 | ||||||
GE gastroesophageal, AEs adverse events
aThe denominator is 24 (the number of Sham patients who crossed over to the Gatekeeper arm)
bOne patient experienced severe chest pain, which was considered serious
cConsidered a serious adverse event
dFour adverse events were reported as device or procedure related but were later adjudicated as not related