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])
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])