TABLE 1.
Disposition of subjects
| Subject disposition | No. (%) of subjects in indicated treatment group:
|
|
|---|---|---|
| Ceftaroline | Standard therapy | |
| Subjects randomized | 67 | 33 |
| Treated (MITT population) | 67 (100.0) | 32 (97.0) |
| Not treated | 0 (0.0) | 1 (3.0) |
| Subjects completing study through EOT | 65 (97.0) | 29 (87.9) |
| Subjects completing study through TOC | 61 (91.0) | 28 (84.8) |
| Subjects completing study through LFU | 59 (88.1) | 26 (78.8) |
| Subjects terminating from study before LFU | 8 (11.9) | 7 (21.2) |
| Primary reason for early discontinuation of study drug or withdrawal from study | ||
| Randomized, did not receive study drug | 0 (0.0) | 1 (14.3) |
| At request of subject, investigator, or sponsora | 1 (12.5) | 0 (0.0) |
| Withdrew consent | 2 (25.0) | 2 (28.6) |
| Lost to follow-up | 3 (37.5) | 1 (14.3) |
| Noncompliance with study drug | 0 (0.0) | 1 (14.3) |
| Unsatisfactory response | 0 (0.0) | 1 (14.3) |
| ≥100% increase of baseline creatinine | 0 (0.0) | 1 (14.3) |
| QTc interval of >500 msb | 1 (12.5) | 0 (0.0) |
| Other adverse eventc | 1 (12.5) | 0 (0.0) |
| Subjects in cMITT population | 67 (100.0) | 32 (97.0) |
| Subjects in mMITT population | 51 (76.1) | 27 (81.8) |
| Subjects in CE population | 61 (91.0) | 27 (81.8) |
| Subjects in ME population | 42 (62.7) | 21 (63.6) |
a
Postrandomization, the subject was determined to have met the exclusion criterion of a seizure history and was withdrawn at the request of the sponsor.
b
Subsequent centrally read ECGs showed the baseline QTc's (Bazett's correction) to be 470, 463, and 448 msec, with a study day 3 predose QTc (Bazett) of 501 msec.
c
Recurrence of infection, which was recorded as an SAE.