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%) |