Table 4 Summary of deaths, adverse events, and serious adverse events (events occurring on or after the day of surgery are shown by preferred term)
HA/CMC powder (n = 105) | No adhesion barrier (n = 104) | |
|---|---|---|
Deaths | 1 (1.0) | 1 (1.0) |
Any adverse event*, n (%) | 66 (62.9)† | 41 (39.4) |
Any adverse event considered severe, n (%)§ | 14 (13.3) | 5 (4.8) |
Most frequently reported adverse events, n (%)§ | ||
Hyperthermia | 6 (5.7) | 3 (2.9) |
Incision site abscess | 5 (4.8) | 3 (2.9) |
Pelvic abscess | 5 (4.8) | 2 (1.9) |
Urinary tract infection | 5 (4.8) | 1 (1.0) |
Anastomotic fistula | 4 (3.8) | 4 (3.8) |
Abdominal wall abscess | 4 (3.8) | 2 (1.9) |
Ileus | 3 (2.9) | 2 (1.9) |
Urinary retention | 3 (2.9) | 1 (1.0) |
At least 1 serious adverse event, n (%) | 29 (27.6)† | 11 (10.6) |
Any serious adverse event considered severe, n (%)§ | 9 (8.6) | 3 (2.9) |
Serious adverse events occurring in ≥2 patients in either group, n (%)§ | ||
Pelvic abscess | 5 (4.8) | 2 (1.9) |
Abdominal abscess | 4 (3.8) | 0 |
Septic shock | 1 (1.0) | 2 (1.9) |
Peritonitis | 2 (1.9) | 3 (2.9) |
Ileus | 3 (2.9) | 0 |
Anastomotic fistula | 3 (2.9) | 4 (3.8) |
Gastrointestinal stoma complication | 2 (1.9) | 0 |