At the end of IV study therapy, CANCIDAS was comparable to amphotericin B in the treatment of candidemia in the MITT population. For the other efficacy time points (Day 10 of IV study therapy, end of all antifungal therapy, 2-week post-therapy follow-up, and 6- to 8-week post-therapy follow-up), CANCIDAS was as effective as amphotericin B.

Outcome, relapse and mortality data are shown in Table 12.

Table 12: Outcomes, Relapse, & Mortality in Candidemia and Other Candida Infections (Intra-abdominal abscesses, peritonitis, and pleural space infections)   CANCIDAS* Amphotericin B % Difference† after
adjusting for strata
(Confidence Interval)‡
*
Patients received CANCIDAS 70 mg on Day 1, then 50 mg daily for the remainder of their treatment.
†
Calculated as CANCIDAS – amphotericin B
‡
95% CI for candidemia, 95.6% for all patients
§
Modified intention-to-treat
¶
Includes all patients who either developed a culture-confirmed recurrence of Candida infection or required antifungal therapy for the treatment of a proven or suspected Candida infection in the follow-up period.
#
Study defined as study treatment period and 6-8 week follow-up period. 
Number of MITT§ patients 109 115 
FAVORABLE OUTCOMES (MITT) AT THE END OF IV STUDY THERAPY
All MITT patients 81/109 (74.3%) 78/115 (67.8%) 7.5 (-5.4, 20.3)
Candidemia
    Neutropenic
    Non-neutropenic 67/92 (72.8%)
6/14 (43%)
61/78 (78%) 63/94 (67.0%)
5/10 (50%)
58/84 (69%) 7.0 (-7.0, 21.1)
Endophthalmitis 0/1 2/3 
Multiple Sites
    Blood / Pleural
    Blood / Peritoneal
    Blood / Urine
    Peritoneal / Pleural
    Abdominal / Peritoneal
    Subphrenic / Peritoneal 4/5
1/1
1/1
-
1/2
-
1/1 4/4
1/1
1/1
1/1
-
1/1
- 
DISSEMINATED INFECTIONS, RELAPSES AND MORTALITY
Disseminated Infections in neutropenic patients 4/14 (28.6%) 3/10 (30.0%) 
All relapses¶ 7/81 (8.6%) 8/78 (10.3%) 
    Culture-confirmed relapse 5/81 (6%) 2/78 (3%) 
Overall study# mortality in MITT
    Mortality during study therapy
    Mortality attributed to Candida 36/109(33.0%)
18/109 (17%)
4/109 (4%) 35/115 (30.4%)
13/115 (11%)
7/115 (6%) 

In this study, the efficacy of CANCIDAS in patients with intra-abdominal abscesses, peritonitis and pleural space Candida infections was eva luated in 19 non-neutropenic patients. Two of these patients had concurrent candidemia. Candida was part of a polymicrobial infection that required adjunctive surgical drainage in 11 of these 19 patients. A favorable response was seen in 9 of 9 patients with peritonitis, 3 of 4 with abscesses (liver, parasplenic, and urinary bladder abscesses), 2 of 2 with pleural space infections, 1 of 2 with mixed peritoneal and pleural infection, 1 of 1 with mixed abdominal abscess and peritonitis, and 0 of 1 with Candida pneumonia.

Overall, across all sites of infection included in the study, the efficacy of CANCIDAS was comparable to that of amphotericin B for the primary endpoint