Informações:
Falhas:
ID
41064
Descrição
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
Palavras-chave
Versões (1)
- 18/06/2020 18/06/2020 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
18 de junho de 2020
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Leukemia NCT01249820
Eligibility Leukemia NCT01249820
- StudyEvent: Eligibility
Similar models
Eligibility Leukemia NCT01249820
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0332197 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])