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The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxisâ„¢) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. | Experimental | Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eraxis (anidulafungin) | Drug | Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT) | Success: Clinical response=Cure (no signs, symptoms [s/s] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up [f/u] culture negative) or Presumed Eradication (f/u culture not available [n/a] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species [spp]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | End of Treatment (Day 5 up to Day 42) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Response at EOT | Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida. | End of Treatment (Day 5 up to Day 42) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33891293 | Derived | De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23. | |
| 31280481 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anidulafungin | Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Diflucan (fluconazole) | Drug | Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis. |
|
| Vfend (voriconazole) | Drug | Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species. |
|
| Number of Participants With Microbiological Response at EOT |
Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida). |
| End of Treatment (Day 5 up to Day 42) |
| Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV) | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | End of Intravenous treatment (Day 5 up to Day 28) |
| Number of Participants With Clinical Response at EOIV | Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida. | End of Intravenous treatment (Day 5 up to Day 28) |
| Number of Participants With Microbiological Response at EOIV | Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida). | End of Intravenous treatment (Day 5 up to Day 28) |
| Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | Week 2 Follow-up |
| Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up | Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida. | Week 2 follow-up |
| Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up | Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida). | Week 2 Follow-up |
| Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS]) | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | Week 6 Follow-up (EOS) |
| Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS) | Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida. | Week 6 follow-up (EOS) |
| Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS) | Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida). | Week 6 Follow-up (EOS) |
| Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | End of Treatment (Day 5 up to Day 42) |
| Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | End of Intravenous treatment (Day 5 up to Day 28) |
| Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | Week 2 Follow-up |
| Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | Week 6 Follow-up (EOS) |
| Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species | Participants with a negative culture on Day 1 were not included in the analysis. For participants with a positive culture on Day 1, the first day on which there was a negative culture was determined and then compared to the result of the next culture. If the next culture was also negative, or the next culture was positive but the interval between the 2 cultures was > 3 days, the earlier of the 2 cultures was the day of first negative blood culture. If next culture was positive and taken within 3 days of the previous culture, the process was repeated with the next negative blood culture. | Baseline (Day 1) up to Week 6 Follow-up (EOS) |
| Medical Resource Utilization (MRU): Duration of Hospital Stay (Days) | Measured as time to dischargeable (medically dischargeable status) and as time to discharge (actual discharge). Analysis of length of hospital stay based on Kaplan-Meier survival techniques. | Baseline up to 6 Week Follow-up (EOS) |
| Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days) | Analysis of length of hospital stay based on Kaplan-Meier survival techniques. | Baseline up to 6 Week Follow-up (EOS) |
| Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days) | Analysis of length of hospital stay based on Kaplan-Meier survival techniques. | Baseline up to End of Intravenous treatment (Day 5 up to Day 28) |
| Medical Resource Utilization (MRU): Duration of Overall Therapy (Days) | Overall therapy includes Intravenous and Oral therapy. Participants were to receive at least 5 days and a maximum of 28 days of IV anidulafungin. After that, participants could continue treatment with oral fluconazole or voriconazole for at least 14 days from the day of last positive culture. | Baseline up to End of Treatment (Day 5 up to Day 42) |
| Number of Participants Per Specified Cause of Death | Cause of death (includes all-cause and attributable to Candida infection) reported based on death due to Serious Adverse Events (SAEs). SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. Participants may be counted with > 1 cause of death if multiple causes were present. | Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) |
| Number of Participants With Non-serious and Serious Adverse Events | AEs are any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. | Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) |
| Number of Participants Who Died | Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90033 | United States |
| Pfizer Investigational Site | San Francisco | California | 94115 | United States |
| Pfizer Investigational Site | San Francisco | California | 94143 | United States |
| Pfizer Investigational Site | Newark | Delaware | 19713 | United States |
| Pfizer Investigational Site | Newark | Delaware | 19718 | United States |
| Pfizer Investigational Site | Wilmington | Delaware | 19801 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32209 | United States |
| Pfizer Investigational Site | Miami | Florida | 33136 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32801 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32819 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30322 | United States |
| Pfizer Investigational Site | Springfield | Illinois | 62701 | United States |
| Pfizer Investigational Site | Springfield | Illinois | 62702 | United States |
| Pfizer Investigational Site | Springfield | Illinois | 62703-9248 | United States |
| Pfizer Investigational Site | Springfield | Illinois | 62703 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21205 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21287 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48201 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48202 | United States |
| Pfizer Investigational Site | Royal Oak | Michigan | 48073 | United States |
| Pfizer Investigational Site | Minneota | Minnesota | 55455 | United States |
| Pfizer Investigational Site | Butte | Montana | 59701 | United States |
| Pfizer Investigational Site | Camden | New Jersey | 08103 | United States |
| Pfizer Investigational Site | Albany | New York | 12208 | United States |
| Pfizer Investigational Site | Buffalo | New York | 14263 | United States |
| Pfizer Investigational Site | Rochester | New York | 14642 | United States |
| Pfizer Investigational Site | Greenville | North Carolina | 27834-6028 | United States |
| Pfizer Investigational Site | Greenville | North Carolina | 27834 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97239 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Pfizer Investigational Site | West Reading | Pennsylvania | 19611 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29414 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Seoul | 120-752 | South Korea |
| Pfizer Investigational Site | Seoul | 135-710 | South Korea |
| Pfizer Investigational Site | Seoul | 137-701 | South Korea |
| Pfizer Investigational Site | Seoul | 138-736 | South Korea |
| Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6. |
| 28597967 | Derived | Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9. |
| 28459966 | Derived | Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116. |
| 24559321 | Derived | Vazquez J, Reboli AC, Pappas PG, Patterson TF, Reinhardt J, Chin-Hong P, Tobin E, Kett DH, Biswas P, Swanson R. Evaluation of an early step-down strategy from intravenous anidulafungin to oral azole therapy for the treatment of candidemia and other forms of invasive candidiasis: results from an open-label trial. BMC Infect Dis. 2014 Feb 21;14:97. doi: 10.1186/1471-2334-14-97. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anidulafungin | Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT) | Success: Clinical response=Cure (no signs, symptoms [s/s] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up [f/u] culture negative) or Presumed Eradication (f/u culture not available [n/a] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species [spp]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | Modified Intent to Treat population (MITT): includes all participants who received at least 1 dose of study medication and with a positive baseline culture for a Candida spp. N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | End of Treatment (Day 5 up to Day 42) |
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| Secondary | Number of Participants With Clinical Response at EOT | Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida. | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | End of Treatment (Day 5 up to Day 42) |
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| Secondary | Number of Participants With Microbiological Response at EOT | Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida). | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | End of Treatment (Day 5 up to Day 42) |
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| Secondary | Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV) | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | End of Intravenous treatment (Day 5 up to Day 28) |
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| Secondary | Number of Participants With Clinical Response at EOIV | Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida. | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | End of Intravenous treatment (Day 5 up to Day 28) |
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| Secondary | Number of Participants With Microbiological Response at EOIV | Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida). | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | End of Intravenous treatment (Day 5 up to Day 28) |
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| Secondary | Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | Week 2 Follow-up |
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| Secondary | Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up | Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida. | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | Week 2 follow-up |
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| Secondary | Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up | Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida). | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | Week 2 Follow-up |
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| Secondary | Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS]) | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | Week 6 Follow-up (EOS) |
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| Secondary | Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS) | Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida. | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | Week 6 follow-up (EOS) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS) | Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological 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 (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida). | MITT; N=number of participants included in analysis (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | Week 6 Follow-up (EOS) |
|
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| Secondary | Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | End of Treatment (Day 5 up to Day 42) |
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| Secondary | Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | End of Intravenous treatment (Day 5 up to Day 28) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | Week 2 Follow-up |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline | Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure). | MITT; N=number of participants in the MITT population where the pathogen isolated at baseline was a Candida spp. other than Candida albicans (participants with missing outcome values were excluded from the analysis). | Posted | Number | participants | Week 6 Follow-up (EOS) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species | Participants with a negative culture on Day 1 were not included in the analysis. For participants with a positive culture on Day 1, the first day on which there was a negative culture was determined and then compared to the result of the next culture. If the next culture was also negative, or the next culture was positive but the interval between the 2 cultures was > 3 days, the earlier of the 2 cultures was the day of first negative blood culture. If next culture was positive and taken within 3 days of the previous culture, the process was repeated with the next negative blood culture. | MITT; Confidence interval (CI) for the median could not be calculated by the software because no event time met the criteria for inclusion into the CI. | Posted | Number | 95% Confidence Interval | days | Baseline (Day 1) up to Week 6 Follow-up (EOS) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Medical Resource Utilization (MRU): Duration of Hospital Stay (Days) | Measured as time to dischargeable (medically dischargeable status) and as time to discharge (actual discharge). Analysis of length of hospital stay based on Kaplan-Meier survival techniques. | MITT; N=number of participants with analyzable data at observation. Time to dischargeable and time to discharge censored at Week 6 Follow-up (EOS). | Posted | Mean | Standard Error | days | Baseline up to 6 Week Follow-up (EOS) |
|
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| Secondary | Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days) | Analysis of length of hospital stay based on Kaplan-Meier survival techniques. | MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS). | Posted | Mean | Standard Error | days | Baseline up to 6 Week Follow-up (EOS) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days) | Analysis of length of hospital stay based on Kaplan-Meier survival techniques. | MITT; N=number of participants with analyzable data at observation. Length of hospital stay censored at Week 6 Follow-up (EOS). | Posted | Mean | Standard Error | days | Baseline up to End of Intravenous treatment (Day 5 up to Day 28) |
|
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| Secondary | Medical Resource Utilization (MRU): Duration of Overall Therapy (Days) | Overall therapy includes Intravenous and Oral therapy. Participants were to receive at least 5 days and a maximum of 28 days of IV anidulafungin. After that, participants could continue treatment with oral fluconazole or voriconazole for at least 14 days from the day of last positive culture. | Intent to Treat (ITT) population includes all participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | days | Baseline up to End of Treatment (Day 5 up to Day 42) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Per Specified Cause of Death | Cause of death (includes all-cause and attributable to Candida infection) reported based on death due to Serious Adverse Events (SAEs). SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. Participants may be counted with > 1 cause of death if multiple causes were present. | Safety analysis set is the same as the Intent-to-Treat population (ITT) and includes all participants who had taken at least 1 dose of study medication. N=number of participants who died with cause of death reported as Serious Adverse Events. | Posted | Number | participants | Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Non-serious and Serious Adverse Events | AEs are any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. | Safety analysis set. An event may have been reported as both a serious and non-serious adverse event, however, what is presented are distinct events; participants may be counted as having experienced > 1 event. | Posted | Number | participants | Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died | Safety analysis set | Posted | Number | participants | Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later) |
|
|
Baseline up to Week 6 Follow-up (EOS)or 30 days after last dose of study drug (whichever was later)
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anidulafungin | Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection. | 134 | 282 | 132 | 282 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Electromechanical dissociation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrointestinal ischaemia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Multi-organ disorder | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chronic hepatic failure | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Fungal endocarditis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pancreatic abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Peridiverticular abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Wound infection bacterial | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Anastomotic haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Failure to anastomose | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Tracheostomy malfunction | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Bleeding time prolonged | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Blood culture positive | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Anoxic encephalopathy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Endotracheal intubation | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Femoral artery embolism | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Phlebitis superficial | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D058387 | Candidemia |
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077612 | Anidulafungin |
| D015725 | Fluconazole |
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
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