ID

34891

Description

Study of the Effect of Eplerenone on Heart Function in Women Receiving Anthracycline Chemotherapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01708798

Link

https://clinicaltrials.gov/show/NCT01708798

Keywords

Versions (1)
  1. 2/3/19 2/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01708798

English

Eligibility Breast Cancer NCT01708798

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage i-iii breast cancer
Description

Breast Carcinoma TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
scheduled to undergo treatment with doxorubicin-based chemotherapy regimen
Description

Doxorubicin Chemotherapy Regimen Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205539
able to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of anthracycline agents other than doxorubicin
Description

Anthracyclines | Exception Doxorubicin

Data type

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013089
baseline lvef ≤50% by any modality (nuclear, echo, mri)
Description

Left ventricular ejection fraction Radionuclide Imaging | Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0034606
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0024485
atrial fibrillation or flutter
Description

Atrial Fibrillation | Atrial Flutter

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0004239
mitral valve disease (more than mild mitral stenosis or regurgitation, previous mitral valve replacement or repair)
Description

Disease of mitral valve | MITRAL STENOSIS MODERATE | Mitral Valve Stenosis Severe | Mitral valve regurgitation, moderate to severe | Replacement of mitral valve | Mitral valvuloplasty

Data type

boolean

Alias
UMLS CUI [1]
C0026265
UMLS CUI [2]
C0746601
UMLS CUI [3,1]
C0026269
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C4478243
UMLS CUI [5]
C0026268
UMLS CUI [6]
C0396849
inability to obtain adequate echo images for required analysis
Description

Echocardiography Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0205412
hyperkalemia (k+ >5.0)
Description

Hyperkalemia | Potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2]
C0202194
glomerular filtration rate (gfr) <30 ml/min/1.73m2
Description

Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0017654
uncontrolled hypertension, defined as having a systolic blood pressure > 180 mmhg and/or a diastolic blood pressure >110 mmhg
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
symptomatic hypotension or systolic blood pressure <85 mmhg
Description

Hypotension symptomatic | Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0863113
UMLS CUI [2]
C0871470
history of hypersensitivity to eplerenone or spironolactone
Description

Hypersensitivity Eplerenone | Spironolactone allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0961485
UMLS CUI [2]
C0571912
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
Description

Liver disease | Viral hepatitis Seropositive | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2,1]
C0042721
UMLS CUI [2,2]
C0521143
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
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)
Description

Spironolactone | Potassium Sparing Diuretics | Potassium supplement | CYP3A4 Inhibitors | Ketoconazole | Itraconazole | nefazodone | Troleandomycin | Clarithromycin | Ritonavir | Nelfinavir

Data type

boolean

Alias
UMLS CUI [1]
C0037982
UMLS CUI [2]
C0304490
UMLS CUI [3]
C0304475
UMLS CUI [4]
C3850053
UMLS CUI [5]
C0022625
UMLS CUI [6]
C0064113
UMLS CUI [7]
C0068485
UMLS CUI [8]
C0041165
UMLS CUI [9]
C0055856
UMLS CUI [10]
C0292818
UMLS CUI [11]
C0525005
history of alcohol and/or any other drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
women who are either pregnant, lactating or of childbearing potential and not using an acceptable method of contraception
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1444641
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0870281
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C0438215
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0013230
UMLS CUI [6,4]
C1444641
UMLS CUI [7,1]
C0008679
UMLS CUI [7,2]
C0013230
UMLS CUI [7,3]
C1444641
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0013230
UMLS CUI [8,3]
C1444641
UMLS CUI [9,1]
C0870281
UMLS CUI [9,2]
C0013230
UMLS CUI [9,3]
C1444641
UMLS CUI [10,1]
C0438215
UMLS CUI [10,2]
C0013230
UMLS CUI [10,3]
C1444641
UMLS CUI [11,1]
C3843040
UMLS CUI [11,2]
C0205082
UMLS CUI [11,3]
C0521102
UMLS CUI [11,4]
C0683954
UMLS CUI [12,1]
C0008679
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0683954
UMLS CUI [13,1]
C3840291
UMLS CUI [13,2]
C0521102
UMLS CUI [13,3]
C0683954
UMLS CUI [14,1]
C0870281
UMLS CUI [14,2]
C0521102
UMLS CUI [14,3]
C0683954
UMLS CUI [15,1]
C0438215
UMLS CUI [15,2]
C0521102
UMLS CUI [15,3]
C0683954
UMLS CUI [16,1]
C3843040
UMLS CUI [16,2]
C0205082
UMLS CUI [16,3]
C2348568
UMLS CUI [16,4]
C1548788
UMLS CUI [17,1]
C0008679
UMLS CUI [17,2]
C2348568
UMLS CUI [17,3]
C1548788
UMLS CUI [18,1]
C3840291
UMLS CUI [18,2]
C2348568
UMLS CUI [18,3]
C1548788
UMLS CUI [19,1]
C0870281
UMLS CUI [19,2]
C2348568
UMLS CUI [19,3]
C1548788
UMLS CUI [20,1]
C0438215
UMLS CUI [20,2]
C2348568
UMLS CUI [20,3]
C1548788
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Similar models

Eligibility Breast Cancer NCT01708798

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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