Table 2. Safety profile.
| Patients with event | Total number of events (% of reports) | Degree of severity | |||
|---|---|---|---|---|---|
| Serious adverse events (SAE) | mild | moderate | severe | ||
| Abscess formation during PEG | 1 (6%)* | 1 (0.2%) | 0 | 0 | 1 |
| Adverse events (AE) | |||||
| Respiratory tract infection | 7 (41%) | 11 (1.7%) | 2 | 9 | 0 |
| Bleeding | 12 (70%) | 155 (24.4%) | 155 | 0 | 0 |
| Swelling | 12 (70%) | 118 (18.6%) | 116 | 2 | 0 |
| Redness | 12 (70%) | 81 (12.7%) | 71 | 7 | 3 |
| Pain | 9 (53%) | 117 (18.4%) | 102 | 15 | 0 |
| Headache | 8 (47%) | 79 (12.4%) | 78 | 1 | 0 |
| Pain (back/body/shoulder) | 3 (18%) | 3 (0.5%) | 3 | 0 | 0 |
| Diarrhoea | 2 (12%) | 3 (0.5%) | 1 | 2 | 0 |
| Gastritis | 1 (6%) | 1 (0.2%) | 1 | 0 | 0 |
* Intention-to-treat population; included 18 patients. The patient with abscess formation dropped out from the study. Data are n (%). PEG = percutaneous endoscopic gastrostomy.