Informações:
Falhas:
ID
27942
Descrição
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.; ODM derived from: https://clinicaltrials.gov/show/NCT00632125
Link
https://clinicaltrials.gov/show/NCT00632125
Palavras-chave
Versões (1)
- 06/12/2017 06/12/2017 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
6 de dezembro de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00632125
Eligibility Chronic Kidney Disease NCT00632125
- StudyEvent: Eligibility
Similar models
Eligibility Chronic Kidney Disease NCT00632125
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Chronic Kidney Disease | Dialysis
Item
ckd subjects with or without dialysis treatment
boolean
C1561643 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0011946 (UMLS CUI [2])
Age
Item
age over 18 years
boolean
C0001779 (UMLS CUI [1])
Erythropoiesis-stimulating Agent Intravenous Patient need for
Item
subjects requiring i.v. esa treatment
boolean
C2917382 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C1522726 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
ESA Intravenous Remaining Probably
Item
subjects likely to remain on i.v. esa treatment for 6 months
boolean
C2917382 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
C0750492 (UMLS CUI [1,4])
C1522726 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
C0750492 (UMLS CUI [1,4])
Informed Consent
Item
provision of informed consent -
boolean
C0021430 (UMLS CUI [1])
Immunosuppressive Agents Systemic | Pharmaceutical Preparations Adverse effects Hemoglobin level
Item
systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level
boolean
C0021081 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0019029 (UMLS CUI [2,3])
C0205373 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0019029 (UMLS CUI [2,3])
Recombinant Erythropoietin Lack of Efficacy Primary | Recombinant Erythropoietin Loss Effect Unknown
Item
known primary lack of efficacy (loe), unexplained loss of effect to a recombinant erythropoietin product
boolean
C0376541 (UMLS CUI [1,1])
C0235828 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0376541 (UMLS CUI [2,1])
C1517945 (UMLS CUI [2,2])
C1280500 (UMLS CUI [2,3])
C0439673 (UMLS CUI [2,4])
C0235828 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0376541 (UMLS CUI [2,1])
C1517945 (UMLS CUI [2,2])
C1280500 (UMLS CUI [2,3])
C0439673 (UMLS CUI [2,4])
Pure Red-Cell Aplasia | Aplastic Anemia
Item
history of prca or aplastic anemia
boolean
C0034902 (UMLS CUI [1])
C0002874 (UMLS CUI [2])
C0002874 (UMLS CUI [2])
Anti-erythropoietin antibody
Item
history of anti-erythropoietin antibodies
boolean
C1328371 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant woman or nursing mother
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling
Item
women of childbearing potential do not agree to maintain effective birth control during the study treatment period.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])