Eligibility ccRCC NCT02293980

  1. StudyEvent: Eligibility
    1. Eligibility ccRCC NCT02293980
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has locally advanced or metastatic ccrcc and has progressed during treatment with at least 1 prior therapeutic regimen
Description

Clear Cell Renal Cell Carcinoma Advanced Locally | Clear-cell metastatic renal cell carcinoma | Disease Progression | Prior Therapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0279702
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C2931852
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C1265611
is of age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
has a life expectancy of ≥ 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
has adequate organ function
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
if a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
Description

Female Sterilization | Postmenopausal state | Gender Contraceptive methods | Gender Partner female Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C0086287
UMLS CUI [4,4]
C0700589
able to swallow oral medications
Description

Able to swallow Oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression
Description

Metastatic malignant neoplasm to brain Untreated | Leptomeningeal disease | Compression of spinal cord

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0751297
UMLS CUI [3]
C0037926
has failed to recover from the reversible effects of prior anticancer therapy
Description

Effect Reversible Due to Cancer treatment | Recovery failed

Data type

boolean

Alias
UMLS CUI [1,1]
C1280500
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0920425
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0231175
has uncontrolled or poorly controlled hypertension
Description

Uncontrolled hypertension | Poor hypertension control

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0421190
is receiving warfarin anticoagulant therapy or expected to require warfarin
Description

Warfarin | Anticoagulant therapy | Requirement Warfarin Expected

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0150457
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0043031
UMLS CUI [3,3]
C1517001
has had any major cardiovascular event within 6 months prior to study drug administration
Description

Cardiovascular event Major

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
Description

Heart Disease | Respiration Disorder | Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0035204
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0459471
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0683954
has had major surgery within 4 weeks before first study drug administration
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
has known hiv
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
has an active infection requiring systemic treatment
Description

Communicable Disease Requirement Systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
is participating in another therapeutic clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility ccRCC NCT02293980

  1. StudyEvent: Eligibility
    1. Eligibility ccRCC NCT02293980
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clear Cell Renal Cell Carcinoma Advanced Locally | Clear-cell metastatic renal cell carcinoma | Disease Progression | Prior Therapy Quantity
Item
has locally advanced or metastatic ccrcc and has progressed during treatment with at least 1 prior therapeutic regimen
boolean
C0279702 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C2931852 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Age
Item
is of age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
has a life expectancy of ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Organ function
Item
has adequate organ function
boolean
C0678852 (UMLS CUI [1])
Female Sterilization | Postmenopausal state | Gender Contraceptive methods | Gender Partner female Contraceptive methods
Item
if a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0086287 (UMLS CUI [4,3])
C0700589 (UMLS CUI [4,4])
Able to swallow Oral medication
Item
able to swallow oral medications
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Untreated | Leptomeningeal disease | Compression of spinal cord
Item
has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0751297 (UMLS CUI [2])
C0037926 (UMLS CUI [3])
Effect Reversible Due to Cancer treatment | Recovery failed
Item
has failed to recover from the reversible effects of prior anticancer therapy
boolean
C1280500 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0920425 (UMLS CUI [1,4])
C2004454 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Uncontrolled hypertension | Poor hypertension control
Item
has uncontrolled or poorly controlled hypertension
boolean
C1868885 (UMLS CUI [1])
C0421190 (UMLS CUI [2])
Warfarin | Anticoagulant therapy | Requirement Warfarin Expected
Item
is receiving warfarin anticoagulant therapy or expected to require warfarin
boolean
C0043031 (UMLS CUI [1])
C0150457 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0043031 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
Cardiovascular event Major
Item
has had any major cardiovascular event within 6 months prior to study drug administration
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Heart Disease | Respiration Disorder | Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results
Item
has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
boolean
C0018799 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
Major surgery
Item
has had major surgery within 4 weeks before first study drug administration
boolean
C0679637 (UMLS CUI [1])
HIV Infection
Item
has known hiv
boolean
C0019693 (UMLS CUI [1])
Communicable Disease Requirement Systemic therapy
Item
has an active infection requiring systemic treatment
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Study Subject Participation Status
Item
is participating in another therapeutic clinical trial
boolean
C2348568 (UMLS CUI [1])