Type of AE | Category E n (%) | Category F n (%) | Category G n (%) | Category H n (%) | Category I n (%) |
---|---|---|---|---|---|
Healthcare-associated infection | 151 (44) | 180 (52) | 10 (3) | 1 | 2 (1) |
Urinary tract infection | 78 (78) | 22 (22) | 0 | 0 | 0 |
Postoperative wound infection | 28 (21) | 99 (73) | 7 (5) | 0 | 1 (1) |
Other infection | 25 (57) | 17 (39) | 2 (5) | 0 | 0 |
Pneumonia (excluding ventilator-associated pneumonia) | 7 (22) | 23 (72) | 0 | 1 (3) | 1 (3) |
Central line associated infection | 4 (57) | 3 (43) | 0 | 0 | 0 |
Ventilator-associated pneumonia | 4 (50) | 4 (50) | 0 | 0 | 0 |
Clostridium difficile positive stool | 3 (75) | 1 (25) | 0 | 0 | 0 |
Sepsis | 2 (14) | 11 (79) | 1 (7) | 0 | 0 |
Distended urinary bladder | 123 (90) | 12 (9) | 1 (1) | 0 | 0 |
Pressure ulcer (category 2–4) | 67 (75) | 22 (25) | 0 | 0 | 0 |
Surgical and other invasive AEs | 41 (32) | 78 (60) | 10 (8) | 1 (1) | 0 |
Other surgical AEs | 17 (47) | 15 (42) | 3 (8) | 1 (3) | 0 |
Postoperative hemorrhage or hematoma (not requiring reoperation) | 16 (47) | 18 (53) | 0 | 0 | 0 |
Reoperation | 7 (14) | 40 (78) | 4 (8) | 0 | 0 |
Wrong side, wrong site, wrong patient | 1 (50) | 1 (50) | 0 | 0 | 0 |
Organ injury | 0 | 4 (57) | 3 (43) | 0 | 0 |
Adverse drug event | 32 (54) | 26 (44) | 0 | 1 (2) | 0 |
Skin or superficial vessel AEs | 31 (78) | 9 (23) | 0 | 0 | 0 |
Falls | 23 (66) | 10 (29) | 2 (6) | 0 | 0 |
Other AEs | 22 (46) | 25 (52) | 1 (2) | 0 | 0 |
Hemorrhage not connected to surgery | 6 (43) | 7 (50) | 1 (7) | 0 | 0 |
Thrombosis or emboli | 5 (24) | 15 (71) | 1 (5) | 0 | 0 |
Allergic reaction | 4 (67) | 2 (33) | 0 | 0 | 0 |
Failure in vital signs | 3 (17) | 9 (50) | 1 (6) | 2 (11) | 3 (17) |
Anesthesia related AEs | 1 (25) | 3 (75) | 0 | 0 | 0 |
Neurological injury | 0 | 3 (50) | 3 (50) | 0 | 0 |
Total | 509 (54) | 401 (42) | 30 (3) | 5 (1) | 5 (1) |