Table 3.
Adverse events
| Adverse events term | Number of events | Number of subjects (%) [1] (N = 30) |
|---|---|---|
| Total | 21 | 15/30 (50.0%) |
| Other [2] | 8 | 8/30 (26.7%) |
| Dysphagia | 5 | 5/30 (16.7%) |
| Pain | 3 | 3/30 (10.0%) |
| Nausea | 2 | 2/30 (6.7%) |
| Diarrhea | 1 | 1/30 (3.3%) |
| Esophageal spasm | 1 | 1/30 (3.3%) |
| Pneumothorax | 1 | 1/30 (3.3%) |
[1]All percentages are calculated using the number of subjects in the FAS as the denominator
[2]Other:
Epigastric pain and bloating (n = 1)
• Esophagitis (n = 1)
• Face tingling and pain (n = 1)
• Foam pooling in throat (n = 1)
• Hypersensitivity to dermabond (n = 1)
• Pleural effusion (n = 1)
• Post-op atelectasis and pleural effusion (n = 1)
• Vomiting, pain in chest and nausea (n = 1)