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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004150-32 | EudraCT Number |
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Prospective, open label study to assess the pharmacokinetics, safety & efficacy of anidulafungin when used to treat children (aged 1 month - <18 years) with invasive candidiasis, including candidemia (ICC).
Prospective, open label study to assess the pharmacokinetics, safety & efficacy of anidulafungin when used to treat children (aged 1 month - < 18 years) with invasive candidiasis, including candidemia (ICC). To participate in the study, at the time of enrollment subjects must (1) have either a confirmed diagnosis of ICC or mycological evidence highly suggestive of Candida sp or (2) in infants 1 month to < 2 years only, be at high risk of candidiasis. All subjects meeting screening criteria receive IV anidulafungin. Subjects will be stratified by age (1 month - < 2 years; 2 years - < 5 years; 5 years - < 18 years). Subjects may be switched to oral fluconazole, provided that the pre-specified criteria are met. Subjects with microbiologically confirmed ICC must have a minimum total treatment duration of 14 days. The maximum allowed treatment duration of anidulafungin is 35 days; the maximum total treatment duration for the study is 49 days. At selected centers, anidulafungin pharmacokinetics will be assessed in the first 6 subjects age 1 month - < 2 years to confirm the recommended dosage regimen. A population PK-PD analysis will be performed in all other enrolled subjects. Subjects will be followed for safety through 6 week FU visit. Efficacy for subjects with confirmed ICC will be assessed at EOIVT, EOT, 2-week FU and 6-week FU visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anidulafungin IV | Experimental | All subjects meeting screening criteria will receive IV anidulafungin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anidulafungin | Drug | Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day). Maximum treatment duration with anidulafungin is 35 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral). | Baseline up to 6 weeks after EOT (up to 91 days) |
| Number of Participants With Laboratory Abnormalities | Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: <0.8*lower limit of normal (LLN); reticulocytes count (absolute or percent): <0.5*LLN or greater than (>) 1.5*upper limit of normal (ULN); Platelets: <0.5*LLN or >1.75*ULN; white blood cell count: <0.6*LLN or >1.5*ULN; neutrophils (absolute or percent): <0.8*LLN or >1.2*ULN; basophils (absolute or percent): >1.2*ULN; lymphocytes (absolute or percent): <0.8*LLN or >1.2*ULN; monocytes (absolute or percent): >1.2*ULN. Serum Chemistry parameters: sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, bicarbonate, calcium: <0.9*LLN or >1.1*ULN; magnesium: >1.1*ULN or <0.9*LLN; BUN (blood urea nitrogen): >1.3* ULN, creatinine: >1.3*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : >3.0*ULN ; total bilirubin: >1.5*ULN; albumin: <0.8*LLN or >1.2*ULN and glucose: <0.6*LLN or >1.5*ULN.EOT visit defined as last day of study treatment (IV or oral). | Baseline up to 6 weeks after EOT (up to 91 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Global Response | Global response categorized: success, failure, indeterminate.Success:clinical response(CR) of cure(resolution of sign, symptoms attributed to Candida infection[CI]; no additional systemic/oral antifungal) or improvement (significant but incomplete resolution of signs symptoms of CI; no additional systemic antifungal) and microbiological eradication/presumed eradication(Baseline pathogen not isolated from original site culture/culture data not available for participant with successful outcome).Failure:CR of failure(no significant improvement in signs symptoms/ death due to CI)and/or microbiological failure(persistence/new infection at follow-up/relapse of infection at follow-up). Indeterminate:CR of indeterminate(evaluation not made or failure assessment)and/or microbiological response of indeterminate(Culture data not available for participant with clinical outcome of indeterminate) and neither response was failure.EOT visit:last day of study treatment (IV or oral). |
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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 |
|---|---|---|---|---|---|---|
| Miller Children's Hospital Bickerstaff Pediatric Family Center | Long Beach | California | 90806 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32032174 | Derived | Roilides E, Carlesse F, Tawadrous M, Leister-Tebbe H, Conte U, Raber S, Swanson R, Yan JL, Aram JA, Queiroz-Telles F; Anidulafungin A8851008 Pediatric Study Group. Safety, Efficacy and Pharmacokinetics of Anidulafungin in Patients 1 Month to <2 Years of Age With Invasive Candidiasis, Including Candidemia. Pediatr Infect Dis J. 2020 Apr;39(4):305-309. doi: 10.1097/INF.0000000000002568. | |
| 30418357 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 16, 2016 | Aug 13, 2018 |
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| Fluconazole | Drug | Subjects may be switched to oral fluconazole [6-12 mg/kg/day (not to exceed 800mg/day] provided they meet specified criteria. Maximum total treatment duration is 49 days. |
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| End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup | Non-compartmental PK analysis was performed on individual plasma anidulafungin concentration-time data collected by serial sampling from participants in the PK sub-study. AUC24 was calculated based on the trapezoidal rule. | Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion |
| Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup | Cmax was obtained directly from the observed concentration data on Day 2. | Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12, and 24 hours after the start of infusion |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 microgram per milliliter (mcg/mL). PK time points were assessed on Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported. | Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours and 24 hours delayed post-dose |
| Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 mcg/ml. PK time points were assessed on at Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported. | Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose |
| Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin | AUC24 values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model. | Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion |
| Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin | Cmin values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model. | Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion |
| Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | The probability of having at least one hepatic adverse event was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. | Baseline to End of intravenous treatment (EOIVT) (maximum of 35 days) |
| Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | The probability of having at least one GI adverse event whilst on Anidulafungin treatment was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. | Baseline to EOIVT (maximum of 35 days) |
| Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | The probabilities of a global response of success or failure were compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. For the analysis of this outcome measure, global response was categorized as: success or failure. Success defined as clinical response (CR) of cure (resolution of signs, symptoms attributed to Candida infection [CI]). Failure defined as CR of failure (no significant improvement in signs symptoms/ death due to CI) and/or microbiological failure (persistence/new infection at follow-up/relapse of infection at follow-up). | EOIVT (maximum of 35 days) and EOT (maximum of 49 days) |
| Percentage of Participants With Relapsed Response | Relapse was defined as any baseline Candida species isolated following eradication (documented or presumed); or culture data not available for a participant with a clinical response of failure after a previous response of success. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection. Participants had received at least 3 doses of study medication to be classified as a failure. Clinical response of success was defined as resolution of sign and symptoms attributed to Candida infection occurred with no additional systemic or oral antifungal treatment required to complete the course of therapy. Eradication or presumed eradication: baseline pathogen not isolated from original site culture(s), or culture data are not available for a participant with successful clinical outcome. End of treatment visit defined as last day of study treatment (IV or oral). | During 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) |
| Percentage of Participants With New Infection | New infection was defined as a participant presenting with clinical failure with the emergence of new Candida species at the original site of infection or at a distant site of infection. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection occurred. Participants had received at least 3 doses of study medication to be classified as a failure. End of treatment visit defined as last day of study treatment (IV or oral). | During 2 week follow-up (up to 63 days) and 6 week follow-up (up to 91 days) after EOT |
| All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | Overall treatment period (up to 49 days); during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) |
| University of California - Los Angeles |
| Los Angeles |
| California |
| 90095-1752 |
| United States |
| University of California - Los Angeles - Ronald Reagan Medical Center | Los Angeles | California | 90095 | United States |
| University of California - Los Angeles - Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Children's Hospital & Research Center Oakland (CHRCO) | Oakland | California | 94609 | United States |
| Children's Hospital of Orange County - Inpatient Pharmacy | Orange | California | 92868 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University Hospitals of Cleveland Laboratory University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Le Bonheur Children's Hospital - 4th Floor | Memphis | Tennessee | 38103 | United States |
| Le Bonheur Children's Hospital - 7th Floor lab | Memphis | Tennessee | 38103 | United States |
| LeBonheur Children's Hospital- Central Laboratory | Memphis | Tennessee | 38103 | United States |
| LeBonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
| Pediatric Clinical Research Unit University of Tennessee Health Science Center | Memphis | Tennessee | 38103 | United States |
| Pediatric Clinical Research Unit- 7th Floor Lab | Memphis | Tennessee | 38103 | United States |
| Pharmacy-University of Tennessee Health Science Center | Memphis | Tennessee | 38103 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38105 | United States |
| University of Tennessee Medical Group Pediatrics | Memphis | Tennessee | 38105 | United States |
| University of Tennessee Health Science Center, Department of Ophthalmology | Memphis | Tennessee | 38163 | United States |
| Cook Children's Infectious Diseases Clinic | Fort Worth | Texas | 76104 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Infectious Diseases Clinic Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Hospital de Clinicas da Universidade Federal do Parana | Curitiba | Paraná | 80060-900 | Brazil |
| Hospital Pequeno Principe | Curitiba | Paraná | 80250-060 | Brazil |
| Hospital Infantil Sabara / Fundacao Jose Luiz Egydio Setubal | São Paulo | São Paulo | 01227-200 | Brazil |
| Instituto PENSI - Pesquisa e Ensino em Saúde Infantil | São Paulo | São Paulo | 01227-200 | Brazil |
| Instituto de Oncologia Pediatrica - Grupo de Apoio ao Adolescente e a Crianca com Cancer | São Paulo | São Paulo | 04039-001 | Brazil |
| Instituto de Oncologia Pediatrica - Grupo de Apoio ao Adolescente e a Crianca com Cancer | São Paulo | 04023-062 | Brazil |
| Stollery Children's Hospital - University of Alberta | Edmonton | Alberta | T6G 2R7 | Canada |
| Aghia Sophia Childrens Hospital | Athens | 11527 | Greece |
| Hippokration Hospital | Thessaloniki | 54642 | Greece |
| Universita degli Studi di Roma La Sapienza | Roma | Province OF ROME | 00161 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesu | Roma | RM | 00165 | Italy |
| Universitario Ospedaliero IRCCS Ospedale Pediatrico Bambino Gesu | Roma | RM | 00165 | Italy |
| National Cancer Research Center RAMS n.a. N.N. Blokhin; Laboratory Microbiological Diagnostics | Moscow | 115478 | Russia |
| Fed. Scientific Center for Pediatric Hematology, Oncology and Immunology of Russian Healthcare Org. | Moscow | 117997 | Russia |
| Asan Medical Center | Songpa-gu | Seoul | 138-736 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
| Asan Medical Center, Department of Pharmacy | Seoul | 138-736 | South Korea |
| Hospital Vall D'Hebron | Barcelona | 08035 | Spain |
| Chang Gung Children's Hospital | Kwei Shan Town | Taoyuan County | 333 | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| Nottingham Children's Hospital | Nottingham | NG7 2UH | United Kingdom |
| Derived |
| Roilides E, Carlesse F, Leister-Tebbe H, Conte U, Yan JL, Liu P, Tawadrous M, Aram JA, Queiroz-Telles F; Anidulafungin A8851008 Pediatric Study Group. A Prospective, Open-label Study to Assess the Safety, Tolerability and Efficacy of Anidulafungin in the Treatment of Invasive Candidiasis in Children 2 to <18 Years of Age. Pediatr Infect Dis J. 2019 Mar;38(3):275-279. doi: 10.1097/INF.0000000000002237. |
| FG001 | Anidulafungin: Participants Aged 2 to <5 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. |
| FG002 | Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. |
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| COMPLETED |
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| NOT COMPLETED |
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The safety population included all randomized participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion. |
| BG001 | Anidulafungin: Participants Aged 2 to <5 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. |
| BG002 | Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral). | The safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to 6 weeks after EOT (up to 91 days) |
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| Primary | Number of Participants With Laboratory Abnormalities | Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: <0.8*lower limit of normal (LLN); reticulocytes count (absolute or percent): <0.5*LLN or greater than (>) 1.5*upper limit of normal (ULN); Platelets: <0.5*LLN or >1.75*ULN; white blood cell count: <0.6*LLN or >1.5*ULN; neutrophils (absolute or percent): <0.8*LLN or >1.2*ULN; basophils (absolute or percent): >1.2*ULN; lymphocytes (absolute or percent): <0.8*LLN or >1.2*ULN; monocytes (absolute or percent): >1.2*ULN. Serum Chemistry parameters: sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, bicarbonate, calcium: <0.9*LLN or >1.1*ULN; magnesium: >1.1*ULN or <0.9*LLN; BUN (blood urea nitrogen): >1.3* ULN, creatinine: >1.3*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : >3.0*ULN ; total bilirubin: >1.5*ULN; albumin: <0.8*LLN or >1.2*ULN and glucose: <0.6*LLN or >1.5*ULN.EOT visit defined as last day of study treatment (IV or oral). | The safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to 6 weeks after EOT (up to 91 days) |
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| Secondary | Number of Participants With Global Response | Global response categorized: success, failure, indeterminate.Success:clinical response(CR) of cure(resolution of sign, symptoms attributed to Candida infection[CI]; no additional systemic/oral antifungal) or improvement (significant but incomplete resolution of signs symptoms of CI; no additional systemic antifungal) and microbiological eradication/presumed eradication(Baseline pathogen not isolated from original site culture/culture data not available for participant with successful outcome).Failure:CR of failure(no significant improvement in signs symptoms/ death due to CI)and/or microbiological failure(persistence/new infection at follow-up/relapse of infection at follow-up). Indeterminate:CR of indeterminate(evaluation not made or failure assessment)and/or microbiological response of indeterminate(Culture data not available for participant with clinical outcome of indeterminate) and neither response was failure.EOT visit:last day of study treatment (IV or oral). | The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection. | Posted | Count of Participants | Participants | End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup | Non-compartmental PK analysis was performed on individual plasma anidulafungin concentration-time data collected by serial sampling from participants in the PK sub-study. AUC24 was calculated based on the trapezoidal rule. | PK subgroup population included the first 6 participants aged between 1 month to <2 years. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion |
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| Secondary | Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup | Cmax was obtained directly from the observed concentration data on Day 2. | PK subgroup population included the first 6 participants aged between 1 month to <2 years. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12, and 24 hours after the start of infusion |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 microgram per milliliter (mcg/mL). PK time points were assessed on Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported. | The PK subgroup population for PS80 included the last eight participants aged between 1 month to <2 years. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours and 24 hours delayed post-dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 mcg/ml. PK time points were assessed on at Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported. | The PK subgroup population for PS80 included the last eight participants aged between 1 month to <2 years. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose |
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| Secondary | Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin | AUC24 values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model. | PK population included all those participants who had 1 or more PK samples available. | Posted | Mean | Standard Deviation | microgram*hour per milliliter(mcg*hr/ml) | Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion |
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| Secondary | Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin | Cmin values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model. | PK population included all those participants who had 1 or more PK samples available. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/ml) | Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion |
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| Secondary | Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | The probability of having at least one hepatic adverse event was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. | Analysis performed on all participants who received at least one dose of the study treatment (Anidulafungin) and had estimable exposure parameters available. | Posted | Count of Participants | Participants | Baseline to End of intravenous treatment (EOIVT) (maximum of 35 days) |
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| Secondary | Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | The probability of having at least one GI adverse event whilst on Anidulafungin treatment was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. | Analysis performed on all participants who received at least one dose of the study treatment (Anidulafungin) and had estimable exposure parameters available. | Posted | Count of Participants | Participants | Baseline to EOIVT (maximum of 35 days) |
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| Secondary | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | The probabilities of a global response of success or failure were compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. For the analysis of this outcome measure, global response was categorized as: success or failure. Success defined as clinical response (CR) of cure (resolution of signs, symptoms attributed to Candida infection [CI]). Failure defined as CR of failure (no significant improvement in signs symptoms/ death due to CI) and/or microbiological failure (persistence/new infection at follow-up/relapse of infection at follow-up). | mITT population: participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'Number analyzed' = Participants evaluable for this outcome measure at specified categories. | Posted | Number | percentage of participants | EOIVT (maximum of 35 days) and EOT (maximum of 49 days) |
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| Secondary | Percentage of Participants With Relapsed Response | Relapse was defined as any baseline Candida species isolated following eradication (documented or presumed); or culture data not available for a participant with a clinical response of failure after a previous response of success. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection. Participants had received at least 3 doses of study medication to be classified as a failure. Clinical response of success was defined as resolution of sign and symptoms attributed to Candida infection occurred with no additional systemic or oral antifungal treatment required to complete the course of therapy. Eradication or presumed eradication: baseline pathogen not isolated from original site culture(s), or culture data are not available for a participant with successful clinical outcome. End of treatment visit defined as last day of study treatment (IV or oral). | The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection. | Posted | Number | percentage of participants | During 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) |
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| Secondary | Percentage of Participants With New Infection | New infection was defined as a participant presenting with clinical failure with the emergence of new Candida species at the original site of infection or at a distant site of infection. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection occurred. Participants had received at least 3 doses of study medication to be classified as a failure. End of treatment visit defined as last day of study treatment (IV or oral). | The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection. | Posted | Number | percentage of participants | During 2 week follow-up (up to 63 days) and 6 week follow-up (up to 91 days) after EOT |
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| Secondary | All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | The safety population included all randomized participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Overall treatment period (up to 49 days); during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) |
|
Baseline up to 6 weeks after end of treatment (up to 91 days)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety population.
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:Participants Aged 1 Month to Less Than(<)2 Years | Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria [1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion. | 1 | 19 | 7 | 19 | 17 | 19 |
| EG001 | Anidulafungin: Participants Aged 2 to <5 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. | 2 | 19 | 10 | 19 | 17 | 19 |
| EG002 | Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. | 5 | 30 | 13 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Aspiration bronchial | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Brachiocephalic vein thrombosis | Vascular disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Unintentional medical device removal | Injury, poisoning and procedural complications | MedDRA v20.1 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pupil fixed | Eye disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pancreatic disorder | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Saliva altered | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Catheter site inflammation | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Catheter site rash | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Relapsing fever | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Splenic abscess | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Uterine abscess | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v20.1 | Non-systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA v20.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Enterobacter test positive | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Klebsiella test positive | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Endometrial neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v20.1 | Non-systematic Assessment |
| |
| Areflexia | Nervous system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Henoch-Schonlein purpura nephritis | Renal and urinary disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Genital erythema | Reproductive system and breast disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Penile oedema | Reproductive system and breast disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Uterine haematoma | Reproductive system and breast disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| catheter site cellulitis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA v20.1 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA v20.1 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA v20.1 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Candida test positive | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Carbon dioxide decreased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA v20.1 | Non-systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA v20.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Tonsillar erythema | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v20.1 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA v20.1 | Non-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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2016 | Aug 13, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058387 | Candidemia |
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| 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 |
| 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
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| OG001 | Anidulafungin: Participants Aged 2 to <5 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. |
| OG002 | Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. |
|
|
| OG001 | Anidulafungin: Participants Aged 2 to <5 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. |
| OG002 | Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| OG001 | Anidulafungin: Participants Aged 2 to <5 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. |
| OG002 | Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. |
|
|
| OG001 | Anidulafungin: Participants Aged 2 to <5 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. |
| OG002 | Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. |
|
|
| OG003 | AUC0-24ss (>89-109 mcg*hr/ml) | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg*h/ml). |
| OG004 | AUC0-24ss (>109 mcg*hr/ml) | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg*h/ml). |
|
|
Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 72 to 89 mcg*h/ml).
| OG003 | AUC0-24ss (>89-109 mcg*hr/ml) | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg*h/ml). |
| OG004 | AUC0-24ss (>109 mcg*hr/ml) | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg*h/ml). |
|
|
Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 61 to 74 mcg*h/ml).
| OG002 | AUC0-24ss (>74-89 mcg*hr/ml) | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 74 to 89 mcg*h/ml). |
| OG003 | AUC0-24ss (>89-112 mcg*hr/ml) | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 112 mcg*h/ml). |
| OG004 | AUC0-24ss (>112 mcg*hr/ml) | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 112 mcg*h/ml). |
|
|
| OG001 | Anidulafungin: Participants Aged 2 to <5 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. |
| OG002 | Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. |
|
|
| OG001 | Anidulafungin: Participants Aged 2 to <5 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. |
| OG002 | Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. |
|
|
Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria [1)afebrile for >=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection] and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.
| OG002 | Anidulafungin: Participants Aged 5 to <18 Years | Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After >=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria ([1)afebrile for >=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures [24 hours apart] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection]and after >=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. |
|
|
| Indeterminate |
|
| Missing |
|
| Indeterminate |
|
| Missing |
|
| Indeterminate |
|
| Missing |
|
|
|
|