TABLE 5.
Adverse event | No. (%) of MITT population receiving indicated treatment:
|
|
---|---|---|
Ceftaroline (n = 67) | Standard therapy (n = 32) | |
Crystals in urine | 6 (9.0) | 5 (15.6) |
Elevated level of blood creatine phosphokinase | 5 (7.5) | 2 (6.3) |
Elevated level of alanine aminotransferase | 4 (6.0)) | 4 (12.5) |
Elevated level of aspartate aminotransferase | 4 (6.0) | 3 (9.4) |
Headache | 4 (6.0) | 2 (6.3) |
Insomnia | 4 (6.0) | 2 (6.3) |
Nausea | 4 (6.0) | 0 (0.0) |
Rashb | 1 (1.5) | 2 (6.3) |
>5% in either treatment group. Infusion-associated AEs are discussed in the text.
Does not include one subject who reportedly had “mononucleosis syndrome” but for whom the major manifestation was a maculopapular rash.