Anidulafungin In Treatment Of Candidemia In Asian Subjects

Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species [spp]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response.

Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response.

Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response.

Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response.

Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).

Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT).

Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter [pg/mL]) summarized at all timeframe endpoints by subject's at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin.

Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as ([mean value of β-D-glucan at observation-baseline value]/baseline value*100).

Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject's at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure).

Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject's EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=([mean value of β-D-glucan at observation-baseline value]/baseline value*100).

Number of subjects with clinician assessed global response of success at EOT (clinical=cure, improvement, microbiological=eradication, presumed eradication) in relation to subject subgroups (subject may be represented in >1 subgroup). Subgroups: Neutropenic status (absolute neutrophil count [ANC in cubic millimeters [cmm]); baseline pathogen; previous surgery (any surgery, abdominal surgery); organ transplantation (kidney, liver, heart); elderly; renal insufficiency (calculated creatinine clearance [CCC] in milliliters per minute [mL/min]); central venous catheter; receiving chemotherapy.