ID

35757

Description

Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT02065791

Link

https://clinicaltrials.gov/show/NCT02065791

Keywords

  1. 3/20/19 3/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 20, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 2 NCT02065791

Eligibility Diabetes Mellitus, Type 2 NCT02065791

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus with a hemoglobin a1c (hba1c) greater than or equal to (>=) 6.5 percent (%) and less than or equal to (<=) 12.0%, with an estimated glomerular filtration rate (egfr) of >= 30 milliliter (ml)/minute (min)/1.73meter (m)^2 and less than (<) 90 ml/min/1.73 m^2
Description

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
UMLS CUI [3]
C3811844
participants need to be on a stable maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb) for at least 4 weeks prior to randomization
Description

Angiotensin-Converting Enzyme Inhibitors Maximum Tolerated Dose Stable Daily | Angiotensin II receptor antagonist Maximum Tolerated Dose Stable Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C0752079
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0332173
UMLS CUI [2,1]
C0521942
UMLS CUI [2,2]
C0752079
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0332173
must have a urine albumin to creatinine ratio (uacr) of greater than (>) 300 milligram (mg)/gram (g) and <= 5000 mg/g
Description

Urine albumin/creatinine ratio measurement

Data type

boolean

Alias
UMLS CUI [1]
C0455271
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of diabetic ketoacidosis or type 1 diabetes mellitus
Description

Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0011854
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
Description

Glucose-galactose malabsorption Hereditary | Renal Glycosuria Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0268186
UMLS CUI [1,2]
C0439660
UMLS CUI [2,1]
C0017980
UMLS CUI [2,2]
C0205225
renal disease that required treatment with immunosuppressive therapy
Description

Kidney Disease Requirement Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
known significant liver disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
current or history of new york heart association (nyha) class iv heart failure
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
blood potassium level >5.5 millimole (mmol)/liter (l) during screening
Description

Blood potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0729816

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02065791

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Estimated Glomerular Filtration Rate
Item
type 2 diabetes mellitus with a hemoglobin a1c (hba1c) greater than or equal to (>=) 6.5 percent (%) and less than or equal to (<=) 12.0%, with an estimated glomerular filtration rate (egfr) of >= 30 milliliter (ml)/minute (min)/1.73meter (m)^2 and less than (<) 90 ml/min/1.73 m^2
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C3811844 (UMLS CUI [3])
Angiotensin-Converting Enzyme Inhibitors Maximum Tolerated Dose Stable Daily | Angiotensin II receptor antagonist Maximum Tolerated Dose Stable Daily
Item
participants need to be on a stable maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb) for at least 4 weeks prior to randomization
boolean
C0003015 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C0521942 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0332173 (UMLS CUI [2,4])
Urine albumin/creatinine ratio measurement
Item
must have a urine albumin to creatinine ratio (uacr) of greater than (>) 300 milligram (mg)/gram (g) and <= 5000 mg/g
boolean
C0455271 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent
Item
history of diabetic ketoacidosis or type 1 diabetes mellitus
boolean
C0011880 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
Glucose-galactose malabsorption Hereditary | Renal Glycosuria Primary
Item
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
boolean
C0268186 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0017980 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Kidney Disease Requirement Therapeutic immunosuppression
Item
renal disease that required treatment with immunosuppressive therapy
boolean
C0022658 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
Liver disease
Item
known significant liver disease
boolean
C0023895 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
current or history of new york heart association (nyha) class iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Blood potassium measurement
Item
blood potassium level >5.5 millimole (mmol)/liter (l) during screening
boolean
C0729816 (UMLS CUI [1])

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