ID

20632

Description

GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00226330

Link

https://clinicaltrials.gov/show/NCT00226330

Keywords

Versions (1)
  1. 3/7/17 3/7/17 -
Uploaded on

March 7, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00226330

English

Eligibility Diabetes Mellitus, Type 2 NCT00226330

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of a written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
men or women who are >= 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
female patients: postmenopausal; hysterectomized; or, if of childbearing potential, using a reliable method of birth control.
Description

Postmenopausal state | Hysterectomy | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0020699
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
completed the last two visits of the randomized treatment period in gallant 6
Description

Patient Visit Quantity Completed | Investigational New Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C0013230
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
new york heart association heart failure class iii or iv
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
treatment with chronic insulin
Description

Insulin chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0205191
history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin)
Description

Hypersensitivity Peroxisome Proliferator-Activated Receptor Agonist | intolerance to Peroxisome Proliferator-Activated Receptor Agonist | Hypersensitivity Actos | intolerance to Actos | Hypersensitivity Avandia | intolerance to Avandia | Fenofibrate allergy | intolerance to Fenofibrate | Hypersensitivity Metformin | intolerance to Metformin | Hypersensitivity Statins | intolerance to Statins

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0166418
UMLS CUI [1,3]
C2987634
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0166418
UMLS CUI [2,3]
C2987634
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0875954
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0875954
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0875967
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0875967
UMLS CUI [7]
C0571869
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0033228
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0025598
UMLS CUI [10,1]
C1744706
UMLS CUI [10,2]
C0025598
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0360714
UMLS CUI [12,1]
C1744706
UMLS CUI [12,2]
C0360714
history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, or neutropenia (low white blood cells)
Description

Myopathy Drug-induced | Elevated creatine kinase Drug-induced | Elevated liver enzyme Drug-induced | Neutropenia Drug-induced

Data type

boolean

Alias
UMLS CUI [1,1]
C0026848
UMLS CUI [1,2]
C0458082
UMLS CUI [2,1]
C0151576
UMLS CUI [2,2]
C0458082
UMLS CUI [3,1]
C0235996
UMLS CUI [3,2]
C0458082
UMLS CUI [4,1]
C0027947
UMLS CUI [4,2]
C0458082
creatinine levels of above twice the normal range
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
creatine kinase of above 3 times the upper limit of normal
Description

Elevated creatine kinase

Data type

boolean

Alias
UMLS CUI [1]
C0151576
previous enrollment in this long-term extension study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
any clinically significant abnormality identified by physical examination, laboratory tests or electrocardiogram, which, in the judgment of the investigator, would compromise the patient's safety or successful participation in the clinical study
Description

Abnormality Physical Examination | Abnormality Laboratory Procedures | Abnormality Electrocardiogram | Abnormality compromises patient safety | Abnormality compromises Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0022885
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0013798
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C1113679
UMLS CUI [5,1]
C1704258
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C2348568
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00226330

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
provision of a written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
men or women who are >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state | Hysterectomy | Childbearing Potential Contraceptive methods
Item
female patients: postmenopausal; hysterectomized; or, if of childbearing potential, using a reliable method of birth control.
boolean
C0232970 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Patient Visit Quantity Completed | Investigational New Drug
Item
completed the last two visits of the randomized treatment period in gallant 6
boolean
C1512346 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
new york heart association heart failure class iii or iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Insulin chronic
Item
treatment with chronic insulin
boolean
C0021641 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Hypersensitivity Peroxisome Proliferator-Activated Receptor Agonist | intolerance to Peroxisome Proliferator-Activated Receptor Agonist | Hypersensitivity Actos | intolerance to Actos | Hypersensitivity Avandia | intolerance to Avandia | Fenofibrate allergy | intolerance to Fenofibrate | Hypersensitivity Metformin | intolerance to Metformin | Hypersensitivity Statins | intolerance to Statins
Item
history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin)
boolean
C0020517 (UMLS CUI [1,1])
C0166418 (UMLS CUI [1,2])
C2987634 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0166418 (UMLS CUI [2,2])
C2987634 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0875954 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0875954 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0875967 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0875967 (UMLS CUI [6,2])
C0571869 (UMLS CUI [7])
C1744706 (UMLS CUI [8,1])
C0033228 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0025598 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C0025598 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0360714 (UMLS CUI [11,2])
C1744706 (UMLS CUI [12,1])
C0360714 (UMLS CUI [12,2])
Myopathy Drug-induced | Elevated creatine kinase Drug-induced | Elevated liver enzyme Drug-induced | Neutropenia Drug-induced
Item
history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, or neutropenia (low white blood cells)
boolean
C0026848 (UMLS CUI [1,1])
C0458082 (UMLS CUI [1,2])
C0151576 (UMLS CUI [2,1])
C0458082 (UMLS CUI [2,2])
C0235996 (UMLS CUI [3,1])
C0458082 (UMLS CUI [3,2])
C0027947 (UMLS CUI [4,1])
C0458082 (UMLS CUI [4,2])
Serum creatinine raised
Item
creatinine levels of above twice the normal range
boolean
C0700225 (UMLS CUI [1])
Elevated creatine kinase
Item
creatine kinase of above 3 times the upper limit of normal
boolean
C0151576 (UMLS CUI [1])
Study Subject Participation Status
Item
previous enrollment in this long-term extension study
boolean
C2348568 (UMLS CUI [1])
Abnormality Physical Examination | Abnormality Laboratory Procedures | Abnormality Electrocardiogram | Abnormality compromises patient safety | Abnormality compromises Study Subject Participation Status
Item
any clinically significant abnormality identified by physical examination, laboratory tests or electrocardiogram, which, in the judgment of the investigator, would compromise the patient's safety or successful participation in the clinical study
boolean
C1704258 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C1704258 (UMLS CUI [3,1])
C0013798 (UMLS CUI [3,2])
C1704258 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
C1704258 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
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