Table 6.
Overall safety in the retrospective and prospective data collection cohorts
| N. of patients with SAEs | 40 (27.6%) |
|---|---|
| Event by preferred term | N. Events |
| Pneumonia | 4 (2.8%) |
| Femur fracture | 3 (2.1%) |
| Cardiac failure | 3 (2.1%) |
| Cardiac arrest | 2 (1.4%) |
| Peripheral neuropathy | 2 (1.4%) |
| Worsening of PD | 2 (1.4%) |
| Peritonitis | 2 (1.4%) |
| Death | 2 (1.4%) |
| Fasciitis | 2 (1.4%) |
| Hip fracture | 1 (0.7%) |
| Humerus fracture | 1 (0.7%) |
| Cerebral haematoma | 1 (0.7%) |
| Headache | 1 (0.7%) |
| Hyperkinesia | 1 (0.7%) |
| Acute myocardial infarction | 1 (0.7%) |
| Gastric ulcer | 1 (0.7%) |
| Haematemesis | 1 (0.7%) |
| Inguinal hernia | 1 (0.7%) |
| Intestinal obstruction | 1 (0.7%) |
| Agitation | 1 (0.7%) |
| Visual hallucination | 1 (0.7%) |
| Suicide attempt | 1 (0.7%) |
| Abnormal weight loss | 1 (0.7%) |
| Hypoglycemia | 1 (0.7%) |
| Acute pulmonary oedema | 1 (0.7%) |
| Pulmonary embolism | 1 (0.7%) |
| Anemia | 1 (0.7%) |
| Deep vein thrombosis | 1 (0.7%) |
| Related to PEG/J procedure or to device | |
| Wrong technique in drug usage process | 2 (1.4%) |
| Gastrostomy tube site complication | 1 (0.7%) |
| Pyrexia | 1 (0.7%) |
| Administration site infection | 1 (0.7%) |
| Stoma site infection | 1 (0.7%) |
| Device occlusion | 1 (0.7%) |
| Medical device complication | 1 (0.7%) |
| Total SAEs | 49 |
| AEs leading to discontinuation | N. patients |
| Any AE leading to discontinuation | 12 (8.3%) |
| Device occlusion/device complication | 2 (1.4%) |
| Abnormal weight loss/hypoglycemia | 2 (1.4%) |
| Fasciitis | 2 (1.4%) |
| Peripheral sensory neuropathy | 2 (1.4%) |
| Cardiac arrest | 1 (0.7%) |
| Peritonitis | 1 (0.7%) |
| Hallucination, visual | 1 (0.7%) |
| Acute pulmonary oedema | 1 (0.7%) |
| Product quality complaints during the study | |
| PQC experienced | 54 (37.2%) |
| Event by preferred term | N. Events |
| Complaints associated with an adverse events | 43 (29.7%) |
| Complaints associated with an ADR | 29 (20%) |
| Complaints associated with a SAE | 14 (9.7%) |
| Risks of PEG insertion | 4 (2.8%) |
| Immediate peristomal infections | 2 |
| Bleedings and injury of internal organs | 1 |
| Infections including peritonitis and pneumoperitoneum | 1 |
| Device Complications (Infusion system) | 30 (20.7%) |
| Accidental removal of PEG tube | 2 |
| Tube occlusion | 11 |
| Dislocation of duodenal tube | 7 |
| Tube rupture, accidental removal, device leakage | 5 |
| Phytobezoar | 5 |
| Surgical procedure | 13 (9%) |
| Encrusted dressing | 1 |
| Signs of inflammation | 3 |
| Granulation tissue | 9 |
| Pump complication/rupture | 8 (5.5%) |