Breast Carcinoma TNM Breast tumor staging
Item
stage i-iii breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Doxorubicin Chemotherapy Regimen Scheduled
Item
scheduled to undergo treatment with doxorubicin-based chemotherapy regimen
boolean
C0013089 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Informed Consent
Item
able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Anthracyclines | Exception Doxorubicin
Item
use of anthracycline agents other than doxorubicin
boolean
C0282564 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013089 (UMLS CUI [2,2])
Left ventricular ejection fraction Radionuclide Imaging | Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MRI
Item
baseline lvef ≤50% by any modality (nuclear, echo, mri)
boolean
C0428772 (UMLS CUI [1,1])
C0034606 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
Atrial Fibrillation | Atrial Flutter
Item
atrial fibrillation or flutter
boolean
C0004238 (UMLS CUI [1])
C0004239 (UMLS CUI [2])
Disease of mitral valve | MITRAL STENOSIS MODERATE | Mitral Valve Stenosis Severe | Mitral valve regurgitation, moderate to severe | Replacement of mitral valve | Mitral valvuloplasty
Item
mitral valve disease (more than mild mitral stenosis or regurgitation, previous mitral valve replacement or repair)
boolean
C0026265 (UMLS CUI [1])
C0746601 (UMLS CUI [2])
C0026269 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C4478243 (UMLS CUI [4])
C0026268 (UMLS CUI [5])
C0396849 (UMLS CUI [6])
Echocardiography Inadequate
Item
inability to obtain adequate echo images for required analysis
boolean
C0013516 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Hyperkalemia | Potassium measurement
Item
hyperkalemia (k+ >5.0)
boolean
C0020461 (UMLS CUI [1])
C0202194 (UMLS CUI [2])
Glomerular Filtration Rate
Item
glomerular filtration rate (gfr) <30 ml/min/1.73m2
boolean
C0017654 (UMLS CUI [1])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension, defined as having a systolic blood pressure > 180 mmhg and/or a diastolic blood pressure >110 mmhg
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hypotension symptomatic | Systolic Pressure
Item
symptomatic hypotension or systolic blood pressure <85 mmhg
boolean
C0863113 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Hypersensitivity Eplerenone | Spironolactone allergy
Item
history of hypersensitivity to eplerenone or spironolactone
boolean
C0020517 (UMLS CUI [1,1])
C0961485 (UMLS CUI [1,2])
C0571912 (UMLS CUI [2])
Liver disease | Viral hepatitis Seropositive | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
significant hepatic disease (e.g., previously documented positive serology for viral hepatitis) or aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) >3 times the upper limits of normal
boolean
C0023895 (UMLS CUI [1])
C0042721 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
Spironolactone | Potassium Sparing Diuretics | Potassium supplement | CYP3A4 Inhibitors | Ketoconazole | Itraconazole | nefazodone | Troleandomycin | Clarithromycin | Ritonavir | Nelfinavir
Item
concomitant treatment with spironolactone, potassium-sparing diuretics, potassium supplements, or strong inhibitors of cytochrome p450 3a4 (cyp3a4) (i.e. ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir)
boolean
C0037982 (UMLS CUI [1])
C0304490 (UMLS CUI [2])
C0304475 (UMLS CUI [3])
C3850053 (UMLS CUI [4])
C0022625 (UMLS CUI [5])
C0064113 (UMLS CUI [6])
C0068485 (UMLS CUI [7])
C0041165 (UMLS CUI [8])
C0055856 (UMLS CUI [9])
C0292818 (UMLS CUI [10])
C0525005 (UMLS CUI [11])
Substance Use Disorders
Item
history of alcohol and/or any other drug abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
women who are either pregnant, lactating or of childbearing potential and not using an acceptable method of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Medical condition Severe Study Subject Participation Status At risk | Chronic disease Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Medical condition Severe Investigational New Drugs At risk | Chronic disease Investigational New Drugs At risk | Mental condition Investigational New Drugs At risk | Chronic mental disorder Investigational New Drugs At risk | Laboratory test result abnormal Investigational New Drugs At risk | Medical condition Severe Interferes with Research results | Chronic disease Interferes with Research results | Mental condition Interferes with Research results | Chronic mental disorder Interferes with Research results | Laboratory test result abnormal Interferes with Research results | Medical condition Severe Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | Chronic mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0870281 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0438215 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0013230 (UMLS CUI [6,3])
C1444641 (UMLS CUI [6,4])
C0008679 (UMLS CUI [7,1])
C0013230 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0013230 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0870281 (UMLS CUI [9,1])
C0013230 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C0438215 (UMLS CUI [10,1])
C0013230 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C3843040 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C0521102 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0008679 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0683954 (UMLS CUI [12,3])
C3840291 (UMLS CUI [13,1])
C0521102 (UMLS CUI [13,2])
C0683954 (UMLS CUI [13,3])
C0870281 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C0683954 (UMLS CUI [14,3])
C0438215 (UMLS CUI [15,1])
C0521102 (UMLS CUI [15,2])
C0683954 (UMLS CUI [15,3])
C3843040 (UMLS CUI [16,1])
C0205082 (UMLS CUI [16,2])
C2348568 (UMLS CUI [16,3])
C1548788 (UMLS CUI [16,4])
C0008679 (UMLS CUI [17,1])
C2348568 (UMLS CUI [17,2])
C1548788 (UMLS CUI [17,3])
C3840291 (UMLS CUI [18,1])
C2348568 (UMLS CUI [18,2])
C1548788 (UMLS CUI [18,3])
C0870281 (UMLS CUI [19,1])
C2348568 (UMLS CUI [19,2])
C1548788 (UMLS CUI [19,3])
C0438215 (UMLS CUI [20,1])
C2348568 (UMLS CUI [20,2])
C1548788 (UMLS CUI [20,3])