ID

41064

Description

Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01249820

Link

https://clinicaltrials.gov/show/NCT01249820

Keywords

Versions (1)
  1. 6/18/20 6/18/20 -
Copyright Holder

See clinicaltrials.gov

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June 18, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01249820

English

Eligibility Leukemia NCT01249820

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01249820
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives intensive chemotherapy for aml-mds
Description

Allogeneic Hematopoietic Stem Cell Transplantation | Status post Myeloablative Chemotherapy | Chemotherapy With intensity Acute Myeloid Leukemia Arising from Previous Myelodysplastic Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1705576
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1513784
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0522510
UMLS CUI [3,3]
C1332153
subject is at least 18 and not older than 65 years of age on the day of the first dosing
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
has no signs or symptoms of invasive fungal disease
Description

Absence Sign or Symptom Invasive Fungal Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C3540840
UMLS CUI [1,3]
C1262313
if a woman, is neither pregnant nor able to become pregnant and is not nursing an infant
Description

Pregnancy Absent | Gender Fertility Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0015895
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
has an alat, alat, alkaline phosphatase < 5 times the upper limit of normal and a bilirubin level < 3 times the upper limit of normal
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201850
UMLS CUI [4]
C1278039
is not known to be hypersensitive to echinocandin antifungal agents
Description

Absence Hypersensitivity Echinocandins

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C1268551
is managed with a quadruple central venous catheter (arrow-howes™ quad-lumen 8.5,5 french; arrow international)
Description

Central venous catheter Quadruple

Data type

boolean

Alias
UMLS CUI [1,1]
C1145640
UMLS CUI [1,2]
C0205175
subject is able and willing to sign the informed consent before screening evaluations
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
Description

Hypersensitivity Pharmacologic Substance Anidulafungin Similar | Hypersensitivity Excipient Anidulafungin Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1254351
UMLS CUI [1,3]
C1142738
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015237
UMLS CUI [2,3]
C1142738
UMLS CUI [2,4]
C2348205
known of positive hiv test or hepatitis b or c test in history
Description

HIV Seropositivity | Hepatitis B test positive | Hepatitis C test positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1608966
UMLS CUI [3]
C1609517
history of qt time prolongation
Description

Prolonged QT interval

Data type

boolean

Alias
UMLS CUI [1]
C0151878
history of or current abuse of drugs, alcohol or solvents
Description

Substance Use Disorders | Solvent abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0876952
inability to understand the nature of the trial and the procedures required
Description

Comprehension Study Protocol Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C1299582
has not previously participated in this trial
Description

Study Subject Participation Status | Absence Participation Previous

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0205156
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Similar models

Eligibility Leukemia NCT01249820

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01249820
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Allogeneic Hematopoietic Stem Cell Transplantation | Status post Myeloablative Chemotherapy | Chemotherapy With intensity Acute Myeloid Leukemia Arising from Previous Myelodysplastic Syndrome
Item
patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives intensive chemotherapy for aml-mds
boolean
C1705576 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1513784 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
C1332153 (UMLS CUI [3,3])
Age
Item
subject is at least 18 and not older than 65 years of age on the day of the first dosing
boolean
C0001779 (UMLS CUI [1])
Absence Sign or Symptom Invasive Fungal Infection
Item
has no signs or symptoms of invasive fungal disease
boolean
C0332197 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
C1262313 (UMLS CUI [1,3])
Pregnancy Absent | Gender Fertility Absent | Breast Feeding Absent
Item
if a woman, is neither pregnant nor able to become pregnant and is not nursing an infant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0015895 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | Serum total bilirubin measurement
Item
has an alat, alat, alkaline phosphatase < 5 times the upper limit of normal and a bilirubin level < 3 times the upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Absence Hypersensitivity Echinocandins
Item
is not known to be hypersensitive to echinocandin antifungal agents
boolean
C0332197 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C1268551 (UMLS CUI [1,3])
Central venous catheter Quadruple
Item
is managed with a quadruple central venous catheter (arrow-howes™ quad-lumen 8.5,5 french; arrow international)
boolean
C1145640 (UMLS CUI [1,1])
C0205175 (UMLS CUI [1,2])
Informed Consent
Item
subject is able and willing to sign the informed consent before screening evaluations
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Pharmacologic Substance Anidulafungin Similar | Hypersensitivity Excipient Anidulafungin Similar
Item
documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
boolean
C0020517 (UMLS CUI [1,1])
C1254351 (UMLS CUI [1,2])
C1142738 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
C1142738 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
HIV Seropositivity | Hepatitis B test positive | Hepatitis C test positive
Item
known of positive hiv test or hepatitis b or c test in history
boolean
C0019699 (UMLS CUI [1])
C1608966 (UMLS CUI [2])
C1609517 (UMLS CUI [3])
Prolonged QT interval
Item
history of qt time prolongation
boolean
C0151878 (UMLS CUI [1])
Substance Use Disorders | Solvent abuse
Item
history of or current abuse of drugs, alcohol or solvents
boolean
C0038586 (UMLS CUI [1])
C0876952 (UMLS CUI [2])
Comprehension Study Protocol Unable
Item
inability to understand the nature of the trial and the procedures required
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Study Subject Participation Status | Absence Participation Previous
Item
has not previously participated in this trial
boolean
C2348568 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
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