Table 4.
Summary of TESAEs of special interest through day 28.
| Patients With Event, n (%) | With Eculizumab (n = 35) |
Without Eculizumab (n = 45) |
P-Valuea |
|---|---|---|---|
| Infectious complications | 20 (57) | 12 (27) | 0.01 |
| Ventilator-associated pneumonia | 18 (51) | 11 (24) | 0.02 |
| Bacteremia | 4 (11) | 1 (2) | 0.2 |
| Urinary tract infection | 0 | 1 (2) | 1 |
| Gastroduodenal hemorrhage | 5 (14) | 7 (16) | 1 |
| Hemolysis | 1 (3) | 8 (18) | 0.07 |
| Cardiac arrhythmia | 1 (3) | 1 (2) | 1 |
| Pulmonary embolism | 1 (3) | 0 | 1 |
| Catheter-related infection | 0 | 1 (2) | 1 |
| Cutaneous rash | 0 | 1 (2) | 1 |
| Leukopenia | 0 | 0 | – |
TESAE=treatment-emergent serious adverse event.
Adverse event terms are based on the Medical Dictionary for Regulatory Activities, version 22.1.
a
Calculated using Fisher's exact test.