ID

15856

Beschreibung

Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge®), Abiraterone Acetate (Zytiga®) or Enzalutamide (Xtandi®) Undergoing Cardiopulmonary EXercise Testing; ODM derived from: https://clinicaltrials.gov/show/NCT02353715

Link

https://clinicaltrials.gov/show/NCT02353715

Stichworte

Versionen (1)
  1. 16.06.16 16.06.16 -
Hochgeladen am

16. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02353715

Englisch

Eligibility Prostate Cancer NCT02353715

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male age ≥ 18 years
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. histologically-confirmed adenocarcinoma of the prostate
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
3. metastatic lesions on bone scan or ct/mri, in the opinion of the treating provider
Beschreibung

Metastatic Lesion Radioisotope scan of bone | Metastatic Lesion X-Ray Computed Tomography | Metastatic Lesion Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513183
UMLS CUI [1,2]
C0203668
UMLS CUI [2,1]
C1513183
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C1513183
UMLS CUI [3,2]
C0024485
4. progressive prostate cancer, in the opinion of the investigator
Beschreibung

Malignant neoplasm of prostate Progressive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0376358
UMLS CUI [1,2]
C0205329
5. surgically or medically castrated, with testosterone levels of < 50 ng/dl
Beschreibung

Castration | Medical Castration | Testosterone measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0007344
UMLS CUI [2]
C1513054
UMLS CUI [3]
C0523912
6. not regularly using opioid pain medication for prostate cancer pain, in the opinion of the treating provider
Beschreibung

Malignant neoplasm of prostate Taking medication for pain | opioid use Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0376358
UMLS CUI [1,2]
C2367290
UMLS CUI [2,1]
C0240602
UMLS CUI [2,2]
C0332197
7. starting either enzalutamide or abiraterone for at least 12 weeks or starting a course of sipuleucel-t
Beschreibung

enzalutamide | abiraterone | sipuleucel-T Course

Datentyp

boolean

Alias
UMLS CUI [1]
C3496793
UMLS CUI [2]
C0754011
UMLS CUI [3,1]
C1706668
UMLS CUI [3,2]
C0750729
8. ecog performance status 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
9. able to read and understand english, in the opinion of the treating provider, well enough to complete the study questionnaires
Beschreibung

Able to read English Language | Comprehension English Language | Completion Clinical study Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0205197
UMLS CUI [3,2]
C0008972
UMLS CUI [3,3]
C0034394
10. subjects on other treatment research protocols are allowed
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
11. able to comply with study requirements
Beschreibung

Compliance behavior Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with chemotherapy for metastatic, castrate-resistant prostate cancer
Beschreibung

Prior Chemotherapy | Metastatic Prostate Carcinoma Male Castration Resistant

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0936223
UMLS CUI [2,2]
C0007347
UMLS CUI [2,3]
C0332325
2. prior treatment with either enzalutamide or abiraterone
Beschreibung

Prior Therapy enzalutamide | Prior Therapy abiraterone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3496793
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0754011
3. subjects who have had any surgical procedure (i.e. turp, etc.) within 4 weeks prior to entering the study.
Beschreibung

Operative Surgical Procedures | Transurethral Resection of Prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0040771
4. subjects receiving treatment with both abiraterone and enzalutamide
Beschreibung

Therapeutic procedure abiraterone enzalutamide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0754011
UMLS CUI [1,3]
C3496793
5. for arm c (sipuleucel-t) only:
Beschreibung

Protocol Treatment Arm | sipuleucel-T

Datentyp

boolean

Alias
UMLS CUI [1]
C1522541
UMLS CUI [2]
C1706668
1. subjects receiving abiraterone or enzalutamide concomitantly with sipuleucel-t
Beschreibung

sipuleucel-T | abiraterone Concomitant | enzalutamide Concomitant

Datentyp

boolean

Alias
UMLS CUI [1]
C1706668
UMLS CUI [2,1]
C0754011
UMLS CUI [2,2]
C2347852
UMLS CUI [3,1]
C3496793
UMLS CUI [3,2]
C2347852
2. subjects who have received prior sipuleucel-t
Beschreibung

Prior Therapy sipuleucel-T

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1706668
6. subjects who have been enrolled on the study previously on a different arm (for example, enrollment on arm c and then transition to arm a on progression is not allowed due to possible selection bias)
Beschreibung

Study Subject Participation Status | Selection Bias

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0036577
7. subjects who are receiving any other investigational agents (i.e. enzalutamide or abiraterone plus an investigational drug).
Beschreibung

Investigational New Drugs Other | enzalutamide | abiraterone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C3496793
UMLS CUI [3]
C0754011
8. subjects with any of the following absolute contraindications to maximal exercise testing as recommended by the american thoracic society and the exercise testing guidelines for cancer subjects, in the opinion of the treating provider: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air desaturation at rest <85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases.
Beschreibung

Medical contraindication Testing Exercise Maximal | Acute myocardial infarction | Angina, Unstable | Uncontrolled Cardiac Arrhythmia Causing Symptoms | Uncontrolled Cardiac Arrhythmia Causing Hemodynamic instability | Syncope | Acute endocarditis | Acute myocarditis | Acute pericarditis | Heart failure Uncontrolled | PULMONARY EMBOLUS ACUTE | pulmonary (acute) infarction | Thrombosis Lower Extremity | Dissecting Aneurysm Suspected | Asthma Uncontrolled | Pulmonary Edema | Room air Oxygen desaturation At rest | Respiratory Failure | Mental impairment Compliance behavior Limited | Secondary malignant neoplasm of bone Extensive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C0015259
UMLS CUI [1,4]
C0205289
UMLS CUI [2]
C0155626
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0678227
UMLS CUI [4,4]
C1457887
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205318
UMLS CUI [5,3]
C0678227
UMLS CUI [5,4]
C0948268
UMLS CUI [6]
C0039070
UMLS CUI [7]
C0375268
UMLS CUI [8]
C0155686
UMLS CUI [9]
C0155679
UMLS CUI [10,1]
C0018801
UMLS CUI [10,2]
C0205318
UMLS CUI [11]
C0748124
UMLS CUI [12]
C2882214
UMLS CUI [13,1]
C0040053
UMLS CUI [13,2]
C0023216
UMLS CUI [14,1]
C0002949
UMLS CUI [14,2]
C0750491
UMLS CUI [15,1]
C0004096
UMLS CUI [15,2]
C0205318
UMLS CUI [16]
C0034063
UMLS CUI [17,1]
C3846005
UMLS CUI [17,2]
C4061338
UMLS CUI [17,3]
C0443144
UMLS CUI [18]
C1145670
UMLS CUI [19,1]
C0683322
UMLS CUI [19,2]
C1321605
UMLS CUI [19,3]
C0439801
UMLS CUI [20,1]
C0153690
UMLS CUI [20,2]
C0205231
9. significant cardiovascular disease, including:
Beschreibung

Cardiovascular Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
1. symptomatic left ventricular dysfunction or known baseline left ventricular ejection fraction (lvef) by multigated acquisition scan (muga) or echocardiogram (echo) of < lower limit of institutional normal (lln). "symptomatic" is defined as new york heart association (nyha) class ii or greater. note: muga and echco do not need to be measured to establish eligibility for this study.
Beschreibung

Left Ventricular Dysfunction Symptomatic | Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography | New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242698
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0521317
UMLS CUI [4]
C0013516
UMLS CUI [5]
C1275491
2. uncontrolled hypertension
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
3. myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug
Beschreibung

Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0002965
4. history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) within 12 months of first dose of study drug
Beschreibung

Ventricular arrhythmia Serious | Tachycardia, Ventricular | Ventricular Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0042514
UMLS CUI [3]
C0042510
5. uncontrolled cardiac arrhythmias
Beschreibung

Cardiac Arrhythmia Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205318
6. coronary or peripheral artery bypass graft within 6 months of first dose of study drug
Beschreibung

Coronary Artery Bypass Surgery | Peripheral artery bypass

Datentyp

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C3495795
7. history of cva, tia, or rest claudication within 6 months of first dose of study drug
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack | Claudication At rest

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3,1]
C1456822
UMLS CUI [3,2]
C0443144
10. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Beschreibung

Intercurrent disease Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277557
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C1321605
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C1321605
UMLS CUI [7,3]
C0439801
11. known or suspected brain metastasis or leptomeningeal disease
Beschreibung

Metastatic malignant neoplasm to brain | Leptomeningeal disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C3160796
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Ähnliche Modelle

Eligibility Prostate Cancer NCT02353715

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. male age ≥ 18 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate
Item
2. histologically-confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Metastatic Lesion Radioisotope scan of bone | Metastatic Lesion X-Ray Computed Tomography | Metastatic Lesion Magnetic Resonance Imaging
Item
3. metastatic lesions on bone scan or ct/mri, in the opinion of the treating provider
boolean
C1513183 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C1513183 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C1513183 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
Malignant neoplasm of prostate Progressive
Item
4. progressive prostate cancer, in the opinion of the investigator
boolean
C0376358 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Castration | Medical Castration | Testosterone measurement
Item
5. surgically or medically castrated, with testosterone levels of < 50 ng/dl
boolean
C0007344 (UMLS CUI [1])
C1513054 (UMLS CUI [2])
C0523912 (UMLS CUI [3])
Malignant neoplasm of prostate Taking medication for pain | opioid use Absent
Item
6. not regularly using opioid pain medication for prostate cancer pain, in the opinion of the treating provider
boolean
C0376358 (UMLS CUI [1,1])
C2367290 (UMLS CUI [1,2])
C0240602 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
enzalutamide | abiraterone | sipuleucel-T Course
Item
7. starting either enzalutamide or abiraterone for at least 12 weeks or starting a course of sipuleucel-t
boolean
C3496793 (UMLS CUI [1])
C0754011 (UMLS CUI [2])
C1706668 (UMLS CUI [3,1])
C0750729 (UMLS CUI [3,2])
ECOG performance status
Item
8. ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Able to read English Language | Comprehension English Language | Completion Clinical study Questionnaire
Item
9. able to read and understand english, in the opinion of the treating provider, well enough to complete the study questionnaires
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0205197 (UMLS CUI [3,1])
C0008972 (UMLS CUI [3,2])
C0034394 (UMLS CUI [3,3])
Study Subject Participation Status
Item
10. subjects on other treatment research protocols are allowed
boolean
C2348568 (UMLS CUI [1])
Compliance behavior Study Protocol
Item
11. able to comply with study requirements
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy | Metastatic Prostate Carcinoma Male Castration Resistant
Item
1. prior treatment with chemotherapy for metastatic, castrate-resistant prostate cancer
boolean
C1514457 (UMLS CUI [1])
C0936223 (UMLS CUI [2,1])
C0007347 (UMLS CUI [2,2])
C0332325 (UMLS CUI [2,3])
Prior Therapy enzalutamide | Prior Therapy abiraterone
Item
2. prior treatment with either enzalutamide or abiraterone
boolean
C1514463 (UMLS CUI [1,1])
C3496793 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0754011 (UMLS CUI [2,2])
Operative Surgical Procedures | Transurethral Resection of Prostate
Item
3. subjects who have had any surgical procedure (i.e. turp, etc.) within 4 weeks prior to entering the study.
boolean
C0543467 (UMLS CUI [1])
C0040771 (UMLS CUI [2])
Therapeutic procedure abiraterone enzalutamide
Item
4. subjects receiving treatment with both abiraterone and enzalutamide
boolean
C0087111 (UMLS CUI [1,1])
C0754011 (UMLS CUI [1,2])
C3496793 (UMLS CUI [1,3])
Protocol Treatment Arm | sipuleucel-T
Item
5. for arm c (sipuleucel-t) only:
boolean
C1522541 (UMLS CUI [1])
C1706668 (UMLS CUI [2])
sipuleucel-T | abiraterone Concomitant | enzalutamide Concomitant
Item
1. subjects receiving abiraterone or enzalutamide concomitantly with sipuleucel-t
boolean
C1706668 (UMLS CUI [1])
C0754011 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C3496793 (UMLS CUI [3,1])
C2347852 (UMLS CUI [3,2])
Prior Therapy sipuleucel-T
Item
2. subjects who have received prior sipuleucel-t
boolean
C1514463 (UMLS CUI [1,1])
C1706668 (UMLS CUI [1,2])
Study Subject Participation Status | Selection Bias
Item
6. subjects who have been enrolled on the study previously on a different arm (for example, enrollment on arm c and then transition to arm a on progression is not allowed due to possible selection bias)
boolean
C2348568 (UMLS CUI [1])
C0036577 (UMLS CUI [2])
Investigational New Drugs Other | enzalutamide | abiraterone
Item
7. subjects who are receiving any other investigational agents (i.e. enzalutamide or abiraterone plus an investigational drug).
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3496793 (UMLS CUI [2])
C0754011 (UMLS CUI [3])
Medical contraindication Testing Exercise Maximal | Acute myocardial infarction | Angina, Unstable | Uncontrolled Cardiac Arrhythmia Causing Symptoms | Uncontrolled Cardiac Arrhythmia Causing Hemodynamic instability | Syncope | Acute endocarditis | Acute myocarditis | Acute pericarditis | Heart failure Uncontrolled | PULMONARY EMBOLUS ACUTE | pulmonary (acute) infarction | Thrombosis Lower Extremity | Dissecting Aneurysm Suspected | Asthma Uncontrolled | Pulmonary Edema | Room air Oxygen desaturation At rest | Respiratory Failure | Mental impairment Compliance behavior Limited | Secondary malignant neoplasm of bone Extensive
Item
8. subjects with any of the following absolute contraindications to maximal exercise testing as recommended by the american thoracic society and the exercise testing guidelines for cancer subjects, in the opinion of the treating provider: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air desaturation at rest <85%, (n) respiratory failure, (o) acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive bone metastases.
boolean
C1301624 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C0205289 (UMLS CUI [1,4])
C0155626 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0678227 (UMLS CUI [4,3])
C1457887 (UMLS CUI [4,4])
C0003811 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0678227 (UMLS CUI [5,3])
C0948268 (UMLS CUI [5,4])
C0039070 (UMLS CUI [6])
C0375268 (UMLS CUI [7])
C0155686 (UMLS CUI [8])
C0155679 (UMLS CUI [9])
C0018801 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
C0748124 (UMLS CUI [11])
C2882214 (UMLS CUI [12])
C0040053 (UMLS CUI [13,1])
C0023216 (UMLS CUI [13,2])
C0002949 (UMLS CUI [14,1])
C0750491 (UMLS CUI [14,2])
C0004096 (UMLS CUI [15,1])
C0205318 (UMLS CUI [15,2])
C0034063 (UMLS CUI [16])
C3846005 (UMLS CUI [17,1])
C4061338 (UMLS CUI [17,2])
C0443144 (UMLS CUI [17,3])
C1145670 (UMLS CUI [18])
C0683322 (UMLS CUI [19,1])
C1321605 (UMLS CUI [19,2])
C0439801 (UMLS CUI [19,3])
C0153690 (UMLS CUI [20,1])
C0205231 (UMLS CUI [20,2])
Cardiovascular Diseases
Item
9. significant cardiovascular disease, including:
boolean
C0007222 (UMLS CUI [1])
Left Ventricular Dysfunction Symptomatic | Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography | New York Heart Association Classification
Item
1. symptomatic left ventricular dysfunction or known baseline left ventricular ejection fraction (lvef) by multigated acquisition scan (muga) or echocardiogram (echo) of < lower limit of institutional normal (lln). "symptomatic" is defined as new york heart association (nyha) class ii or greater. note: muga and echco do not need to be measured to establish eligibility for this study.
boolean
C0242698 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
C0013516 (UMLS CUI [4])
C1275491 (UMLS CUI [5])
Uncontrolled hypertension
Item
2. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable
Item
3. myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
Ventricular arrhythmia Serious | Tachycardia, Ventricular | Ventricular Fibrillation
Item
4. history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) within 12 months of first dose of study drug
boolean
C0085612 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0042514 (UMLS CUI [2])
C0042510 (UMLS CUI [3])
Cardiac Arrhythmia Uncontrolled
Item
5. uncontrolled cardiac arrhythmias
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Coronary Artery Bypass Surgery | Peripheral artery bypass
Item
6. coronary or peripheral artery bypass graft within 6 months of first dose of study drug
boolean
C0010055 (UMLS CUI [1])
C3495795 (UMLS CUI [2])
Cerebrovascular accident | Transient Ischemic Attack | Claudication At rest
Item
7. history of cva, tia, or rest claudication within 6 months of first dose of study drug
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C1456822 (UMLS CUI [3,1])
C0443144 (UMLS CUI [3,2])
Intercurrent disease Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
Item
10. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0277557 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C1321605 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C1321605 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Metastatic malignant neoplasm to brain | Leptomeningeal disease
Item
11. known or suspected brain metastasis or leptomeningeal disease
boolean
C0220650 (UMLS CUI [1])
C3160796 (UMLS CUI [2])
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