Informações:
Falhas:
ID
33693
Descrição
Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01581658
Link
https://clinicaltrials.gov/show/NCT01581658
Palavras-chave
Versões (1)
- 19/12/2018 19/12/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
19 de dezembro de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01581658
Eligibility Diabetes Mellitus, Type 2 NCT01581658
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT01581658
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes patients
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin>= 6.1% (japan diabetes society)
boolean
C0474680 (UMLS CUI [1])
GFR estimation by MDRD
Item
estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of >= 15 ml/min/1.73m2
boolean
C2170215 (UMLS CUI [1])
Disease Significant | Exception Renal Insufficiency
Item
any evidence of significant disease (other than renal impairment)
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1565489 (UMLS CUI [2,2])
C0750502 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1565489 (UMLS CUI [2,2])
Liver Dysfunction Moderate | Liver Dysfunction Severe
Item
moderate and severe concurrent liver function impairment
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Gastrointestinal Surgical Procedure Affecting Drug absorption | Gastrointestinal Surgical Procedure Affecting Drug elimination
Item
gastrointestinal tract surgery, that might affect absorption and elimination of drugs
boolean
C0524722 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0524722 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683141 (UMLS CUI [2,3])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0524722 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683141 (UMLS CUI [2,3])
CNS disorder | Epilepsy | Mental disorders | Nervous system disorder
Item
diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
boolean
C0007682 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0014544 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
Chronic infectious disease | Communicable Diseases
Item
chronic or relevant acute infections
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C0009450 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0013230 (UMLS CUI [2])