Table 4.
Adverse Events and Serious Adverse Events of Patients Who Received Ceftolozane/Tazobactam and Those Who Received the Standard of Care
| Event | Ceftolozane/Tazobactam (n = 47) |
Standard of Care (n = 50) |
P Value |
|---|---|---|---|
| Total AEs | 38 (81) | 37 (74) | .42 |
| Total SAEs | 33 (70) | 33 (66) | .66 |
| Study drug–related AE | 8 (17) | 3 (6) | .09 |
| ALT increased (>ULN) | 2 (4) | 1 (2) | |
| Bilirubin increased (>1.5 ULN) | 1 (2) | … | |
| Rash | 5 (11) | 2 (4) | |
| Alkaline phosphatase increased (>ULN) | 1 (2) | … | |
| Headache | 1 (2) | … | |
| Study drug–related SAE | 1 (2) | 0 (0) | .48 |
| Bilirubin increased (>1.5 ULN) | 1 (2) | … | |
| Study drug–related AE resulting in drug discontinuation | 2 (4) | 2 (4) | >.99 |
| ALT increased (>ULN) | … | 1 (2) | |
| Bilirubin increased (>1.5 ULN) | 1 (2) | … | |
| Rash | 1 (2) | 1 (2) | |
| Study drug–related SAE resulting in drug discontinuation | 1 (2) | 0 (0) | .48 |
| Bilirubin increased (>1.5 ULN) | 1 (2) | … | |
| Mortality | 3 (6) | 2 (4) | .67 |
| Study drug–related mortality | 0 | 0 | |
| 30-d all-cause mortality | 2 (4) | 2 (4) | >.99 |
Data are presented as No. of patients (%) unless otherwise indicated.
Abbreviation: AE, adverse event; ALT, alanine aminotransferase; SAE, serious adverse event; ULN, upper limit of normal.