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])
Gender | Postmenopausal | Hysterectomy | Childbearing Potential Contraceptive methods
Item
female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Antidiabetic agent Oral Single | Antidiabetics Oral Quantity | Antidiabetics Oral Low dose
Item
treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
boolean
C0012159 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
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 regime chronic
Item
treatment with chronic insulin
boolean
C0557978 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Hypersensitivity Peroxisome Proliferator-Activated Receptors | intolerance to Peroxisome Proliferator-Activated Receptors | Hypersensitivity Actos | Hypersensitivity Avandia | Fenofibrate allergy | Metformin allergy | Hypersensitivity Hydroxymethylglutaryl-CoA Reductase Inhibitors | intolerance to Actos | intolerance to Avandia | intolerance to Fenofibrate | intolerance to Metformin | intolerance to Hydroxymethylglutaryl-CoA Reductase Inhibitors
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])
C1744706 (UMLS CUI [2,1])
C0166418 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0875954 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0875967 (UMLS CUI [4,2])
C0571869 (UMLS CUI [5])
C0571648 (UMLS CUI [6])
C0020517 (UMLS CUI [7,1])
C0360714 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0875954 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C0875967 (UMLS CUI [9,2])
C1744706 (UMLS CUI [10,1])
C0033228 (UMLS CUI [10,2])
C1744706 (UMLS CUI [11,1])
C0025598 (UMLS CUI [11,2])
C1744706 (UMLS CUI [12,1])
C0360714 (UMLS CUI [12,2])
Drug-induced myopathy | Elevated creatine kinase Drug-induced | Elevated liver enzymes Drug-induced | Neutropenia Drug-induced
Item
history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
boolean
C0410220 (UMLS CUI [1])
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 above twice the normal range
boolean
C0700225 (UMLS CUI [1])
Elevated creatine kinase
Item
creatine kinase above 3 times the upper limit of normal
boolean
C0151576 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
received any investigational product in other clinical studies within 12 weeks
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Abnormality Clinical Significance Affecting Patient safety | Abnormality Clinical Significance Limiting Study Subject Participation Status | Physical Examination | Laboratory Procedures | Electrocardiography
Item
any clinically significant abnormality identified on 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])
C2826293 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C1704258 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0031809 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C1623258 (UMLS CUI [5])