Trial Outcomes & Findings for This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis (NCT NCT00548262)

Last Updated: 2011-01-17

Results Overview

Clinical Success (cure=resolution of Candida signs and symptoms \[s/s\] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

End of Treatment (EOT) (up to Day 42)

Results posted on

2011-01-17

Participant Flow

The planned sample size for this study was 210 subjects; however, due to slow enrollment, only 54 subjects were screened and randomized.

Participant milestones

Participant milestones
Measure	Anidulafungin-Voriconazole Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Overall Study STARTED	54
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Anidulafungin-Voriconazole Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Overall Study Death	21
Overall Study Adverse Event	2
Overall Study Lack of Efficacy	4
Overall Study Lost to Follow-up	1
Overall Study Other	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anidulafungin-Voriconazole n=54 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Age, Customized Between 18 and 44 years	18 participants n=5 Participants
Age, Customized Between 45 and 64 years	18 participants n=5 Participants
Age, Customized ≥ 65 years	18 participants n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: End of Treatment (EOT) (up to Day 42)

Population: Modified Intent-to-Treat population (MITT): all Intent-to-Treat (ITT) participants (took at least 1 dose of study treatment) and with a positive baseline culture for a Candida spp within 96 hours before entry into the study. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment Success	26 participants Interval 44.6 to 73.6
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment Failure	18 participants

SECONDARY outcome

Timeframe: End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up

Population: MITT. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for Failure.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) EIVT Success	26 participants Interval 44.6 to 73.6
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) EIVT Failure	18 participants
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) Week 2 Follow-up Success	21 participants Interval 33.0 to 62.5
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) Week 2 Follow-up Failure	23 participants

SECONDARY outcome

Timeframe: Baseline, EIVT (up to Day 42)

Population: MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida albicans: Success	11 participants Interval 31.0 to 73.7
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida albicans: Failure	10 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida famata: Success	1 participants Interval 0.0 to 100.0
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida famata: Failure	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida glabrata: Failure	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida guilliermondii: Success	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida guilliermondii: Failure	0 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida krusei: Success	2 participants Interval 13.3 to 100.0
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida krusei: Failure	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida parapsilosis: Success	1 participants Interval 0.0 to 46.5
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida parapsilosis: Failure	5 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida pelliculosa: Success	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida pelliculosa: Failure	0 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida tropicalis: Success	8 participants Interval 55.2 to 100.0
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida tropicalis: Failure	2 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Unidentifiable: Success	4 participants Interval 20.5 to 93.8
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Unidentifiable: Failure	3 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT Candida glabrata: Success	2 participants Interval 13.3 to 100.0

SECONDARY outcome

Timeframe: Baseline, EOT (up to Day 42)

Population: MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida albicans: Success	11 participants Interval 31.0 to 73.7
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida albicans: Failure	10 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida famata: Success	0 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida famata: Failure	2 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida glabrata: Success	2 participants Interval 13.3 to 100.0
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida glabrata: Failure	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida guilliermondii: Success	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida krusei: Success	2 participants Interval 13.3 to 100.0
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida krusei: Failure	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida parapsilosis: Success	1 participants Interval 0.0 to 46.5
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida pelliculosa: Success	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida pelliculosa: Failure	0 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida tropicalis: Failure	2 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Unidentifiable: Success	4 participants Interval 20.5 to 93.8
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Unidentifiable: Failure	3 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida guilliermondii: Failure	0 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida parapsilosis: Failure	5 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT Candida tropicalis: Success	8 participants Interval 55.2 to 100.0

SECONDARY outcome

Timeframe: Baseline, Week 2 Follow-up

Population: MITT. Missing or indeterminate set to Failure; CI was not calculated for status of Failure.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida albicans: Success	10 participants Interval 26.3 to 69.0
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida albicans: Failure	11 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida famata: Success	0 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida guilliermondii: Failure	0 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida krusei: Success	2 participants Interval 13.3 to 100.0
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida krusei: Failure	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida pelliculosa: Failure	0 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida tropicalis: Success	7 participants Interval 41.6 to 98.4
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida tropicalis: Failure	3 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Unidentifiable: Success	2 participants Interval 0.0 to 62.0
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida famata: Failure	2 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida glabrata: Success	3 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida glabrata: Failure	0 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida guilliermondii: Success	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida parapsilosis: Success	0 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida parapsilosis: Failure	6 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Candida pelliculosa: Success	1 participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up Unidentifiable: Failure	5 participants

SECONDARY outcome

Timeframe: Baseline, EOT (up to Day 42)

Population: MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly (\>65 years of age); not summarized.

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT ICU stay ≥ 4 days (Yes): Success	18 participants Interval 39.1 to 73.4
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT ICU stay ≥ 4 days (Yes): Failure	14 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT ICU stay ≥ 4 days (No): Success	8 participants Interval 40.0 to 93.3
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT ICU stay ≥ 4 days (No): Failure	4 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Mechanical ventilation (Yes): Success	18 participants Interval 37.6 to 71.5
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Mechanical ventilation (Yes): Failure	15 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Mechanical ventilation (No): Success	8 participants Interval 46.4 to 99.0
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Mechanical ventilation (No): Failure	3 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Antibiotics (Yes): Success	22 participants Interval 40.8 to 72.0
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Chemotherapy (Yes): Success	1 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Neutropenic: Failure	1 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Solid organ transplant (No): Failure	18 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Antibiotics (No): Success	4 participants Interval 44.9 to 100.0
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Antibiotics (No): Failure	1 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Antibiotics (Yes): Failure	17 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT CV Catheter (Yes): Success	21 participants Interval 39.5 to 71.1
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT CV Catheter (Yes): Failure	17 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT CV Catheter (No): Success	5 participants Interval 53.5 to 100.0
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT CV Catheter (No): Failure	1 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT TPN (Yes): Success	5 participants Interval 12.0 to 64.9
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT TPN (Yes): Failure	8 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT TPN (No): Success	21 participants Interval 51.3 to 84.2
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT TPN (No): Failure	10 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Dialysis (Yes): Success	3 participants Interval 6.2 to 79.5
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Dialysis (Yes): Failure	4 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Dialysis (No): Success	23 participants Interval 46.5 to 77.8
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Dialysis (No): Failure	14 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Abdominal surgery (Yes): Success	11 participants Interval 35.7 to 80.1
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Abdominal surgery (Yes): Failure	8 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Abdominal surgery (No): Success	15 participants Interval 40.8 to 79.2
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Abdominal surgery (No): Failure	10 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Solid organ transplant (No): Success	26 participants Interval 44.6 to 73.6
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Renal insufficiency (Yes): Success	3 participants Interval 6.2 to 79.5
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Renal insufficiency (Yes): Failure	4 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Renal insufficiency (No): Success	23 participants Interval 46.5 to 77.8
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Renal insufficiency (No): Failure	14 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Chemotherapy (Yes): Failure	0 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Chemotherapy (No): Success	25 participants Interval 43.4 to 72.9
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Chemotherapy (No): Failure	18 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Pancreatitis (Yes): Success	1 participants Interval 0.0 to 55.1
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Pancreatitis (Yes): Failure	4 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Pancreatitis (No): Success	25 participants Interval 49.0 to 79.2
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Pancreatitis (No): Failure	14 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Systemic steroids/immunos (Yes): Success	6 participants Interval 21.7 to 78.3
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Systemic steroids/immunos (Yes): Failure	6 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Systemic steroids/immunos (No): Success	20 participants Interval 45.7 to 79.3
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Systemic steroids/immunos (No): Failure	12 participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Neutropenic: Success	2 participants Interval 13.3 to 100.0
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Non-neutropenic: Success	18 participants Interval 44.4 to 79.7
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT Non-neutropenic: Failure	11 participants

SECONDARY outcome

Timeframe: EIVT (up to Day 42)

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT CV Catheter (No): Success	5 participants Interval 53.5 to 100.0
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT CV Catheter (No): Failure	1 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT TPN (Yes): Success	6 participants Interval 19.1 to 73.3
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT TPN (No): Success	20 participants Interval 47.7 to 81.4
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Abdominal surgery (Yes): Failure	7 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Renal insufficiency (Yes): Success	3 participants Interval 6.2 to 79.5
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Pancreatitis (No): Success	24 participants Interval 46.3 to 76.8
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Pancreatitis (No): Failure	15 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Systemic steroids/immunos (Yes): Success	7 participants Interval 30.4 to 86.2
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Systemic steroids/immunos (No): Failure	13 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Neutropenic: Failure	1 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT ICU stay ≥ 4 days (Yes): Success	18 participants Interval 39.1 to 73.4
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT ICU stay ≥ 4 days (Yes): Failure	14 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT ICU stay ≥ 4 days (No): Success	8 participants Interval 40.0 to 93.3
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT ICU stay ≥ 4 days (No): Failure	4 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Mechanical ventilation (Yes): Success	18 participants Interval 37.6 to 71.5
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Mechanical ventilation (Yes): Failure	15 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Mechanical ventilation (No): Success	8 participants Interval 46.4 to 99.0
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Mechanical ventilation (No): Failure	3 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Antibiotics (Yes): Success	22 participants Interval 40.8 to 72.0
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Antibiotics (Yes): Failure	17 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Antibiotics (No): Success	4 participants Interval 44.9 to 100.0
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Antibiotics (No): Failure	1 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT CV Catheter (Yes): Success	21 participants Interval 39.5 to 71.1
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT CV Catheter (Yes): Failure	17 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT TPN (Yes): Failure	7 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT TPN (No): Failure	11 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Dialysis (Yes): Success	3 participants Interval 6.2 to 79.5
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Dialysis (Yes): Failure	4 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Dialysis (No): Success	23 participants Interval 46.5 to 77.8
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Dialysis (No): Failure	14 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Abdominal surgery (Yes): Success	12 participants Interval 41.5 to 84.8
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Abdominal surgery (No): Success	14 participants Interval 36.5 to 75.5
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Abdominal surgery (No): Failure	11 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Solid organ transplant (No): Success	26 participants Interval 44.6 to 73.6
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Solid organ transplant (No): Failure	18 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Renal insufficiency (Yes): Failure	4 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Renal insufficiency (No): Success	23 participants Interval 46.5 to 77.8
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Renal insufficiency (No): Failure	14 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Chemotherapy (Yes): Success	1 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Chemotherapy (Yes): Failure	0 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Chemotherapy (No): Success	25 participants Interval 43.4 to 72.9
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Chemotherapy (No): Failure	18 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Pancreatitis (Yes): Success	2 participants Interval 0.0 to 82.9
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Pancreatitis (Yes): Failure	3 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Systemic steroids/immunos (Yes): Failure	5 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Systemic steroids/immunos (No): Success	19 participants Interval 42.4 to 76.4
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Neutropenic: Success	2 participants Interval 13.3 to 100.0
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Non-neutropenic: Success	18 participants Interval 44.4 to 79.7
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT Non-neutropenic: Failure	11 participants

SECONDARY outcome

Timeframe: Baseline, Week 2 Follow-up (F/U)

Population: MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data insufficient for analysis by status=elderly \>65 years of age; not summarized.

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up ICU stay ≥ 4 days (No): Success	9 participants Interval 50.5 to 99.5
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up ICU stay ≥ 4 days (No): Failure	3 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Antibiotics (Yes): Failure	20 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Antibiotics (No): Success	2 participants Interval 0.0 to 82.9
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Antibiotics (No): Failure	3 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up CV Catheter (Yes): Success	18 participants Interval 31.5 to 63.2
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up CV Catheter (No): Failure	3 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up TPN (Yes): Failure	8 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Abdominal surgery (Yes): Success	8 participants Interval 19.9 to 64.3
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Abdominal surgery (No): Failure	12 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Renal insufficiency (No): Success	20 participants Interval 38.0 to 70.1
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Chemotherapy (No): Failure	23 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Pancreatitis (Yes): Success	2 participants Interval 0.0 to 82.9
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up ICU stay ≥ 4 days (Yes): Success	12 participants Interval 20.7 to 54.3
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up ICU stay ≥ 4 days (Yes): Failure	20 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Mechanical ventilation (Yes): Success	13 participants Interval 22.7 to 56.1
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Mechanical ventilation (Yes): Failure	20 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Mechanical ventilation (No): Success	8 participants Interval 46.4 to 99.0
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Mechanical ventilation (No): Failure	3 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Antibiotics (Yes): Success	19 participants Interval 33.0 to 64.4
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up CV Catheter (Yes): Failure	20 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up CV Catheter (No): Success	3 participants Interval 10.0 to 90.0
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up TPN (Yes): Success	5 participants Interval 12.0 to 64.9
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up TPN (No): Success	16 participants Interval 34.0 to 69.2
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up TPN (No): Failure	15 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Dialysis (Yes): Success	1 participants Interval 0.0 to 40.2
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Dialysis (Yes): Failure	6 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Dialysis (No): Success	20 participants Interval 38.0 to 70.1
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Dialysis (No): Failure	17 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Abdominal surgery (Yes): Failure	11 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Abdominal surgery (No): Success	13 participants Interval 32.4 to 71.6
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Solid organ transplant (No): Success	21 participants Interval 33.0 to 62.5
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Solid organ transplant (No): Failure	23 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Renal insufficiency (Yes): Success	1 participants Interval 0.0 to 40.2
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Renal insufficiency (Yes): Failure	6 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Renal insufficiency (No): Failure	17 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Chemotherapy (Yes): Success	1 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Chemotherapy (Yes): Failure	0 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Chemotherapy (No): Success	20 participants Interval 31.6 to 61.4
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Pancreatitis (Yes): Failure	3 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Pancreatitis (No): Success	19 participants Interval 33.0 to 64.4
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Pancreatitis (No): Failure	20 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Systemic steroids/immunos (Yes): Success	5 participants Interval 13.8 to 69.6
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Systemic steroids/immunos (Yes): Failure	7 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Systemic steroids/immunos (No): Success	16 participants Interval 32.7 to 67.3
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Systemic steroids/immunos (No): Failure	16 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Neutropenic: Success	2 participants Interval 13.3 to 100.0
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Neutropenic: Failure	1 participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Non-neutropenic: Success	15 participants Interval 33.5 to 69.9
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up Non-neutropenic: Failure	14 participants

SECONDARY outcome

Timeframe: EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up

Population: MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score \<20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE ≥20 (EIVT): Success	2 participants Interval 0.0 to 49.4
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE ≥20 (EIVT): Failure	7 participants
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE ≥20 (Week 2 F/U): Success	1 participants Interval 0.0 to 31.6
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE <20 (EIVT): Success	24 participants Interval 53.2 to 84.0
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE <20 (EIVT): Failure	11 participants
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE <20 (EOT): Success	25 participants Interval 56.5 to 86.4
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE <20 (EOT): Failure	10 participants
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE ≥20 (EOT): Success	1 participants Interval 0.0 to 31.6
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE ≥20 (EOT): Failure	8 participants
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE <20 (Week 2 F/U): Success	20 participants Interval 40.7 to 73.5
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE <20 (Week 2 F/U): Failure	15 participants
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score APACHE ≥20 (Week 2 F/U): Failure	8 participants

SECONDARY outcome

Timeframe: Day 30

Population: MITT

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants Per Survival Status (Alive or Dead) on Day 30 Alive	25 participants
Number of Participants Per Survival Status (Alive or Dead) on Day 30 Dead	19 participants

SECONDARY outcome

Timeframe: Baseline to Week 6 Follow-up

Population: MITT. MITT. Death for 1 participant reported twice in this study(recorded at End of Treatment and at End of Study); both instances are reported in this table under Attributal Death=No.

Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded "disease under study" as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=44 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis Attributable death (Yes)	4 participants
Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis Attributable death (No)	19 participants

SECONDARY outcome

Timeframe: Baseline to Week 2 Follow-up

Population: MITT; data not summarized using descriptive statistics.

Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Day 42

Population: Safety analysis set: all participants who received any dose of study medication.

Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=54 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment	10.0 days Interval 1.0 to 28.0

SECONDARY outcome

Timeframe: Baseline to Week 6 Follow-up

Population: MITT; data not summarized using descriptive statistics.

Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Week 6 Follow-up

Population: MITT; N=number of participants evaluable for length of time in ICU.

Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=32 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Length of Stay in Intensive Care Unit (ICU)	16.0 Days Interval 8.0 to 29.0

SECONDARY outcome

Timeframe: Baseline to Week 2 Follow-up

Population: Safety analysis population

Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=54 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Change From Baseline in Vital Signs: Supine Blood Pressure Baseline median: supine systolic BP	120.0 mmHg Measure of dispersion was not calculated for baseline median.
Change From Baseline in Vital Signs: Supine Blood Pressure Change from baseline: supine systolic BP	0.00 mmHg Measure of dispersion was not calculated for median change from baseline.
Change From Baseline in Vital Signs: Supine Blood Pressure Baseline median: supine diastolic BP	66.0 mmHg Measure of dispersion was not calculated for baseline median.
Change From Baseline in Vital Signs: Supine Blood Pressure Change from baseline: supine diastolic BP	0.00 mmHg Measure of dispersion was not calculated for median change from baseline.

SECONDARY outcome

Timeframe: Baseline to Week 2 Follow-up

Population: Safety analysis population

Supine heart rate measured as beats per minute (bpm).

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=54 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Change From Baseline in Vital Signs: Supine Heart Rate Baseline median: supine heart rate	97.5 bpm Measure of dispersion was not calculated for baseline median.
Change From Baseline in Vital Signs: Supine Heart Rate Change from baseline: supine heart rate	3.00 bpm Measure of dispersion was not calculated for median change from baseline.

SECONDARY outcome

Timeframe: Baseline to Week 2 Follow-up

Population: Safety analysis population; N=number of participants with evaluable data.

Weight measured as kilograms (kg).

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=30 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Change From Baseline in Vital Signs: Weight Baseline median: weight	65.0 kg Measure of dispersion was not calculated for baseline median.
Change From Baseline in Vital Signs: Weight Change from baseline: weight	-0.70 kg Measure of dispersion was not calculated for median change from baseline.

SECONDARY outcome

Timeframe: Baseline to Week 2 Follow-up

Population: Safety analysis population

Temperature measured as degrees of Celsius (C).

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=54 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Change From Baseline in Vital Signs: Temperature Baseline median: temperature	37.5 Degrees of Celsius Measure of dispersion was not calculated for baseline median.
Change From Baseline in Vital Signs: Temperature Change from baseline: temperature	-0.30 Degrees of Celsius Measure of dispersion was not calculated for median change from baseline.

SECONDARY outcome

Timeframe: Baseline to Week 2 Follow-up

Population: Safety analysis population

Respiration rate measured as respirations per minute (resp/min).

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=54 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Change From Baseline in Vital Signs: Respiration Rate Baseline median: respiration rate	20.0 resp/min Measure of dispersion was not calculated for baseline median.
Change From Baseline in Vital Signs: Respiration Rate Change from baseline: respiration rate	-0.50 resp/min Measure of dispersion was not calculated for median change from baseline.

SECONDARY outcome

Timeframe: Baseline to Week 2 Follow-up

Population: Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.

Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=27 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Baseline median: total bilirubin (n=19)	0.6 mg/dL Measure of dispersion was not calculated for baseline median.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Change from baseline: total bilirubin	-0.2 mg/dL Measure of dispersion was not calculated for median change from baseline.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Baseline median: direct bilirubin (n=19)	0.2 mg/dL Measure of dispersion was not calculated for baseline median.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Change from baseline: direct bilirubin	-0.1 mg/dL Measure of dispersion was not calculated for median change from baseline.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Baseline median: indirect bilirubin (n=17)	0.3 mg/dL Measure of dispersion was not calculated for baseline median.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Change from baseline: indirect bilirubin	0.0 mg/dL Measure of dispersion was not calculated for median change from baseline.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Baseline median: blood urea nitrogen (n=25)	37.4 mg/dL Measure of dispersion was not calculated for baseline median.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Change from baseline: blood urea nitrogen	-4.8 mg/dL Measure of dispersion was not calculated for median change from baseline.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Baseline median: creatinine (n=27)	0.8 mg/dL Measure of dispersion was not calculated for baseline median.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Change from baseline: creatinine	0.0 mg/dL Measure of dispersion was not calculated for median change from baseline.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Baseline median: glucose (n=24)	99 mg/dL Measure of dispersion was not calculated for baseline median.
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) Change from baseline: glucose	-6 mg/dL Measure of dispersion was not calculated for median change from baseline.

SECONDARY outcome

Timeframe: Baseline to Week 2 Follow-up

Population: Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.

Chemistry laboratory test data measured as international units per (IU/L).

Outcome measures

Outcome measures
Measure	Anidulafungin-Voriconazole n=18 Participants Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) Baseline median: alanine aminotransferase (n=16)	45 IU/L Measure of dispersion was not calculated for baseline median.
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) Change from baseline: alanine aminotransferase	-5 IU/L Measure of dispersion was not calculated for median change from baseline.
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) Baseline median: aspartate aminotransferase (n=18)	43 IU/L Measure of dispersion was not calculated for baseline median.
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) Change from baseline: aspartate aminotransferase	-18 IU/L Measure of dispersion was not calculated for median change from baseline.
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) Baseline median: lactate dehydrogenase (n=13)	536 IU/L Measure of dispersion was not calculated for baseline median.
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) Change from baseline: lactate dehydrogenase	-160 IU/L Measure of dispersion was not calculated for median change from baseline.
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) Baseline median: alkaline phosphatase (n=17)	114 IU/L Measure of dispersion was not calculated for baseline median.
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) Change from baseline: alkaline phosphatase	26 IU/L Measure of dispersion was not calculated for median change from baseline.

Adverse Events

Anidulafungin-Voriconazole

Serious events: 29 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Anidulafungin-Voriconazole n=54 participants at risk Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Gastrointestinal disorders Intestinal perforation	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Pancreatic insufficiency	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Death	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Drug ineffective	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Multi-organ disorder	7.4% 4/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic failure	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Anastomotic leak	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Failure to anastomose	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Post procedural fistula	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Wound dehiscence	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Abdominal sepsis	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Abdominal wall abscess	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Endocarditis	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Fusarium infection	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pelvic infection	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia klebsiella	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pulmonary sepsis	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Septic shock	20.4% 11/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Blood disorder	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Acute myocardial infarction	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial fibrillation	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac arrest	3.7% 2/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardio-respiratory arrest	7.4% 4/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Supraventricular tachycardia	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Ventricular arrhythmia	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Ventricular tachycardia	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia recurrrent	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Convulsion	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Partial seizures	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Anuria	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure	3.7% 2/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Lung disorder	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Arterial thrombosis	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Circulatory collapse	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	3.7% 2/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypovolaemic shock	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Lupus vasculitis	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Shock	1.9% 1/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Shock haemorrhagic	3.7% 2/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Anidulafungin-Voriconazole n=54 participants at risk Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter.
Blood and lymphatic system disorders Anaemia	9.3% 5/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	7.4% 4/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	18.5% 10/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	7.4% 4/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	5.6% 3/54 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

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Phone: 1-800-718-1021

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER