The rate of successful treatment of documented baseline infections, a component of the primary endpoint, was not statistically different between treatment groups.

The response rates did not differ between treatment groups based on either of the stratification variables: risk category or prior antifungal prophylaxis.
14.2 Candidemia and the following other Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections
In a Phase III randomized, double-blind study, patients with a proven diagnosis of invasive candidiasis received daily doses of CANCIDAS (50 mg/day following a 70-mg loading dose on Day 1) or amphotericin B deoxycholate (0.6 to 0.7 mg/kg/day for non-neutropenic patients and 0.7 to 1.0 mg/kg/day for neutropenic patients). Patients were stratified by both neutropenic status and APACHE II score. Patients with Candida endocarditis, meningitis, or osteomyelitis were excluded from this study.

Patients who met the entry criteria and received one or more doses of IV study therapy were included in the modified intention-to-treat [MITT] analysis of response at the end of IV study therapy. A favorable response at this time point required both symptom/sign resolution/improvement and microbiological clearance of the Candida infection.

Two hundred thirty-nine patients were enrolled. Patient disposition is shown in Table 11.

Table 11: Disposition in Candidemia and Other Candida Infections (Intra-abdominal abscesses, peritonitis, and pleural space infections)  
CANCIDAS*
Amphotericin B
*
Patients received CANCIDAS 70 mg on Day 1, then 50 mg daily for the remainder of their treatment.
†
Study defined as study treatment period and 6-8 week follow-up period.
‡
Determined by the investigator to be possibly, probably, or definitely drug-related. 
Randomized patients 114 125
Patients completing study† 63 (55.3%) 69 (55.2%)
DISCONTINUATIONS OF STUDY†
All Study Discontinuations  51 (44.7%) 56 (44.8%)
      Study Discontinuations due to clinical adverse events 39 (34.2%) 43 (34.4%)
      Study Discontinuations due to laboratory adverse events 0 (0%) 1 (0.8%)
DISCONTINUATIONS OF STUDY THERAPY
All Study Therapy Discontinuations  48 (42.1%) 58 (46.4%)
      Study Therapy Discontinuations due to clinical adverse events 30 (26.3%) 37 (29.6%)
      Study Therapy Discontinuations due to laboratory adverse events 1 (0.9%) 7 (5.6%)
      Study Therapy Discontinuations due to all drug-related‡ adverse events 3 (2.6%) 29 (23.2%)

Of the 239 patients enrolled, 224 met the criteria for inclusion in the MITT population (109 treated with CANCIDAS and 115 treated with amphotericin B). Of these 224 patients, 186 patients had candidemia (92 treated with CANCIDAS and 94 treated with amphotericin B). The majority of the patients with candidemia were non-neutropenic (87%) and had an APACHE II score less than or equal to 20 (77%) in both arms. Most candidemia infections were caused by C. al