Table 3.
Summary of Adverse Events (AEs) and Device Complications N (%)
| Overall, N (%) | LCIG N = 37 | LC-Oral N = 34 | Total N = 71 |
|---|---|---|---|
| Any AE | 35 (94·6) | 34 (100·0) | 69 (97·2) |
| Serious AE* | 5 (13·5)a | 7 (20·6)b | 12 (16·9) |
| Abdominal pain | 19 (51·4) | 11 (32·4) | 30 (42·3) |
| Nausea | 11 (29·7) | 7 (20·6) | 18 (25·4) |
| Procedural Pain | 11 (29·7) | 12 (35·3) | 23 (32·4) |
| Constipation | 8 (21·6) | 7 (20·6) | 15 (21·1) |
| Incision Site Erythema | 7 (18·9) | 4 (11·8) | 11 (15·5) |
| Flatulence | 6 (16·2) | 4 (11·8) | 10 (14·1) |
| Dyskinesia | 5 (13·5) | 4 (11·8) | 9 (12·7) |
| Orthostatic Hypotension | 5 (13·5) | 8 (23·5) | 13 (18·3) |
| Depression | 4 (10·8) | 1 (2·9) | 5 (7·0) |
| Fall | 4 (10·8) | 4 (11·8) | 8 (11·3) |
| Insomnia | 4 (10·8) | 4 (11·8) | 8 (11·3) |
| Pneumoperitoneum | 4 (10·8) | 1 (2·9) | 5 (7·0) |
| Post-procedure Discharge | 4 (10·8) | 3 (8·8) | 7 (9·9) |
| Wound Infection | 4 (10·8) | 8 (23·5) | 12 (16·9) |
| Device complication | 34 (91·9) | 29 (85·3) | 63 (88·7) |
| Intestinal tube comp | 14 (37·8) | 12 (35·3) | 26 (36·6) |
| Leakage | 2 | 1 | 3 |
| Insertion complication | 3 | 1 | 4 |
| Dislocation | 8 | 9 | 17 |
| Occlusion | 5 | 4 | 9 |
| Unintentional removal | 0 | 1 | 1 |
| PEG-J comp | 11(29·7) | 12 (35·3) | 23 (32·4) |
| Breakage | 1 | 0 | 1 |
| Insertion complication | 8 | 7 | 15 |
| Dislocation | 2 | 3 | 5 |
| Occlusion | 0 | 1 | 1 |
| Connection issue | 1 | 3 | 4 |
| Unintentional removal | 0 | 1 | 1 |
| Pump comp | 5 (13·5) | 8 (23·5) | 13 (18·3) |
| Breakage | 1 | 0 | 1 |
| Malfunction | 3 | 3 | 6 |
| Occlusion | 1 | 2 | 3 |
| Stoma comp | 15 (40·5) | 15 (44·1) | 30 (42·3) |
| Leakage | 2 | 1 | 3 |
| Insertion complication | 2 | 5 | 7 |
| Dislocation | 0 | 1 | 1 |
| Connection issue | 0 | 1 | 1 |
*
SAEs included:
a
2 events of confusional state, and 1 event each of pneumoperitoneum, complication of device insertion, catheter site cellulitis, hypersomnia, delusions, hallucinations, mutism, and psychotic disorder
b
2 events of pheumonia, and 1 event each of neutropenia, abdominal pain, peritonitis, postprocedural complication, elevated body temperature, depressed level of consciousness, mental status change, psychosis, and orthostatic hypotension. More than 1 could be in the same individual.