Informações:
Falhas:
ID
29239
Descrição
Effect of Renal Impairment on the Pharmacokinetics of NN9535; ODM derived from: https://clinicaltrials.gov/show/NCT00833716
Link
https://clinicaltrials.gov/show/NCT00833716
Palavras-chave
Versões (1)
- 10/03/2018 10/03/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
10 de março de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes NCT00833716
Eligibility Diabetes NCT00833716
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT00833716
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Informed Consent
Item
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject)
boolean
C0021430 (UMLS CUI [1])
Glomerular Filtration Rate | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
subjects meeting the pre-defined gfr (glomerular filtration rate) criteria (estimated by the cockcroft & gault formula) for any of the renal function groups
boolean
C0017654 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
C2711451 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) equal to or less than 40kg/m2
boolean
C1305855 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Kidney Transplantation
Item
renal transplanted patients
boolean
C0022671 (UMLS CUI [1])
Cardiac problem | Heart failure | Angina, Unstable | Myocardial Infarction
Item
certain cardiac problems (heart failure, unstable angina, mi (myocardial infarction) within the last 3 months)
boolean
C0262402 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0018801 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Liver Dysfunction | Liver disease Severe
Item
known current hepatic dysfunction or severe hepatic disease during the last 12 months
boolean
C0086565 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0023895 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Childbearing Potential | Breast Feeding
Item
female of childbearing potential/breast feeding
boolean
C3831118 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Alcoholic Intoxication, Chronic | Drug abuse
Item
history of alcoholism or drug abuse
boolean
C0001973 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
C0013146 (UMLS CUI [2])
Blood Donation
Item
blood donation during the last 8 weeks prior to the study
boolean
C0005794 (UMLS CUI [1])
Pancreatitis
Item
past or current history of pancreatitis
boolean
C0030305 (UMLS CUI [1])