Table 2. Post-adjudication: incidence of all major and minor SAEs occurring in ≥2 patients.

Category and preferred term	Patient incidence, n (%)a	Procedural incidence, %b	Literature range, %ref(s)
Major SAEs	61 (15.4)	13.0
Peritonitis	7 (1.8)	1.5	0.5–1.327
Pneumoniac	7 (1.8)	1.5	0.3–3.012, 24, 27, 28, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40
Abdominal paind	6 (1.5)	1.3	4.0–1310
Pneumoperitoneume	4 (1.0)	0.9	0.5–1.312, 24, 27, 28, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40
Post-operative wound infection	3 (0.8)	0.6	5.4–3010, 11, 26, 41, 42, 43, 44
Acute abdomen	2 (0.5)	0.4	NR
Gastrointestinal hemorrhage	2 (0.5)	0.4	0–2.512, 24, 27, 28, 31, 32, 33, 34, 36, 37, 38, 39, 40, 45, 46
Ileus paralytic	2 (0.5)	0.4	1–212, 24, 27, 28, 31, 32, 33, 34, 35, 36, 37, 38, 40
Intestinal ischemia	2 (0.5)	0.4	NR
Intestinal perforation	2 (0.5)	0.4	0.526
Sepsis	2 (0.5)	0.4	NR
Minor SAEs	36 (9.1)	7.7
Abdominal pain	7 (1.8)	1.5	4.0–1310
Pneumoperitoneum	7 (1.8)	1.5	0.5–1.3
Post-operative wound infection	3 (0.8)	0.6	5.4–3010
Parkinson's diseasef	3 (0.8)	0.6	NR

NR, no reported rate; SAE, serious adverse event.

^aPatient incidence is relative to all patients who received a PEG-J (n=395).

^bProcedural incidence is relative to all the PEG-J procedures performed (n=468).

^cRange is for aspiration pneumonia.

^dAbdominal pain requiring hospitalization without other diagnosis.

^ePneumoperitoneum with concomitant abdominal pain with or without signs of infection.

^fParkinson's disease refers to the re-emergence of Parkinson's symptoms, often due to interruption of drug delivery.