| Primary | Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment | 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). | 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. | Posted | | Number | | participants | | End of Treatment (EOT) (up to Day 42) | | | | ID | Title | Description |
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| OG000 | 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. |
| | | Title | Denominators | Categories |
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| Success | | | | Failure | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | percentage of participants with success | 59.1 | | | 2-Sided | 95 | 44.6 | 73.6 | | | 95% CI based on normal approximation to the binomial. | No | Superiority or Other | | |
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| Secondary | Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) | 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). | MITT. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for Failure. | Posted | | Number | | participants | | End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | 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 at EIVT was assessed per the type of Candida species that was isolated at the baseline visit. | MITT. Missing or indeterminate set to Failure; CI not calculated for Failure. | Posted | | Number | | participants | | Baseline, EIVT (up to Day 42) | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | 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 at EOT was assessed per the type of Candida species that was isolated at the baseline visit. | MITT. Missing or indeterminate set to Failure; CI not calculated for Failure. | Posted | | Number | | participants | | Baseline, EOT (up to Day 42) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | 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 at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit. | MITT. Missing or indeterminate set to Failure; CI was not calculated for status of Failure. | Posted | | Number | | participants | | Baseline, Week 2 Follow-up | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | 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. | 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. | Posted | | Number | | participants | | Baseline, EOT (up to Day 42) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | 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. | 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. | Posted | | Number | | participants | | EIVT (up to Day 42) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | 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. | 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. | Posted | | Number | | participants | | Baseline, Week 2 Follow-up (F/U) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | 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. | MITT. Missing or indeterminate set to Failure; CI not calculated for Failure. | Posted | | Number | | participants | | EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Number of Participants Per Survival Status (Alive or Dead) on Day 30 | | | Posted | | Number | | participants | | Day 30 | | | | ID | Title | Description |
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| OG000 | 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. |
| | |
| Secondary | Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis | 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. | 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. | Posted | | Number | | participants | | Baseline to Week 6 Follow-up | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Time to Negative Blood, Specimen, or Tissue Culture | 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). | MITT; data not summarized using descriptive statistics. | Posted | | Number | | Days | | Baseline to Week 2 Follow-up | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment | 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. | Safety analysis set: all participants who received any dose of study medication. | Posted | | Median | Full Range | days | | Baseline to Day 42 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Length of Hospital Stay | 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. | MITT; data not summarized using descriptive statistics. | Posted | | Number | | days | | Baseline to Week 6 Follow-up | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Length of Stay in Intensive Care Unit (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. | MITT; N=number of participants evaluable for length of time in ICU. | Posted | | Median | 95% Confidence Interval | Days | | Baseline up to Week 6 Follow-up | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in Vital Signs: Supine Blood Pressure | Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg). | Safety analysis population | Posted | | Median | Full Range | mmHg | | Baseline to Week 2 Follow-up | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in Vital Signs: Supine Heart Rate | Supine heart rate measured as beats per minute (bpm). | Safety analysis population | Posted | | Median | Full Range | bpm | | Baseline to Week 2 Follow-up | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in Vital Signs: Weight | Weight measured as kilograms (kg). | Safety analysis population; N=number of participants with evaluable data. | Posted | | Median | Full Range | kg | | Baseline to Week 2 Follow-up | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in Vital Signs: Temperature | Temperature measured as degrees of Celsius (C). | Safety analysis population | Posted | | Median | Full Range | Degrees of Celsius | | Baseline to Week 2 Follow-up | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in Vital Signs: Respiration Rate | Respiration rate measured as respirations per minute (resp/min). | Safety analysis population | Posted | | Median | Full Range | resp/min | | Baseline to Week 2 Follow-up | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Chemistry laboratory test data measured as milligrams per deciliter (mg/dL). | Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation. | Posted | | Median | Full Range | mg/dL | | Baseline to Week 2 Follow-up | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) | Chemistry laboratory test data measured as international units per (IU/L). | Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation. | Posted | | Median | Full Range | IU/L | | Baseline to Week 2 Follow-up | | | | ID | Title | Description |
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| OG000 | 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. |
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