Table 2. Adverse events occurring in 5% or more of participants and serious adverse events in the AspireAssist group (N=111), and time period in which the event occurred (i) <7 days (perioperative) and (ii) >7days (postoperative) of A-tube placement.
| Adverse events | No. of participants (%) | No. of participants, perioperative | No. of participants, postoperative |
|---|---|---|---|
| Peristomal granulation tissue | 45 (40.5%) | 0 | 45 |
| Abdominal pain within 4 weeks after A-tube placementa | 42 (37.8%) | 41 | 1 |
| Nausea/vomiting | 19 (17.1%) | 15 | 4 |
| Peristomal irritation | 19 (17.1%) | 2 | 17 |
| Intermittent abdominal discomfort | 18 (16.2%) | 16 | 2 |
| Possible or definite peristomal bacterial infection | 15 (13.5%) | 13 | 2 |
| Abdominal pain 4 weeks or more after A-tube placementa | 9 (8.1%) | 0 | 9 |
| Dyspepsia (acid reflux, heartburn, hiccups, belching) | 7 (6.3%) | 1 | 6 |
| Peristomal inflammation | 6 (5.4%) | 4 | 2 |
| Serious adverse events | |||
| Severe abdominal pain | 1 (0.9%) | 1 | |
| Peritonitis | 1 (0.9%) | 1 | |
| Pre-pyloric ulcer | 1 (0.9%) | 1 | |
| A-tube replacement because of Skin-Port malfunction | 1 (0.9%) | 1 | |
a
Defined as abdominal pain not relieved with standard oral analgesic therapy.