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. 2019 May 27;266(9):2164–2176. doi: 10.1007/s00415-019-09337-6

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%)