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Eligibility Autosomal Dominant Polycystic Kidney Disease NCT01022424

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the preceding study (156-05-002)
Description

Study Subject Participation Status | Protocol Compliance | Patient withdrawn from trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0525058
UMLS CUI [3]
C0422727
patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up.
Description

Study Subject Participation Status | Adverse events resolved | Adverse events Stable

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1514893
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with egfr of less than 15 ml/min/1.73 m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
patients with any of the following complications:
Description

Complications

Data type

boolean

Alias
UMLS CUI [1]
C0009566
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)
Description

Cardiovascular Diseases Serious | Heart failure | Liver diseases | Liver Cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0023890
patients with any of the following complications or history thereof:
Description

Complications

Data type

boolean

Alias
UMLS CUI [1]
C0009566
clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity
Description

Drug Allergy | Drug related anaphylaxis | Hypersensitivity Benzazepine derivatives | Hypersensitivity Suspected Benzazepine derivatives

Data type

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0850607
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0005034
UMLS CUI [3,3]
C0243072
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0005034
UMLS CUI [4,4]
C0243072
inability to personally give consent due to a mental illness
Description

Mental disorders Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Autosomal Dominant Polycystic Kidney Disease NCT01022424

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Protocol Compliance | Patient withdrawn from trial
Item
patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the preceding study (156-05-002)
boolean
C2348568 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0422727 (UMLS CUI [3])
Study Subject Participation Status | Adverse events resolved | Adverse events Stable
Item
patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up.
boolean
C2348568 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Estimated Glomerular Filtration Rate
Item
patients with egfr of less than 15 ml/min/1.73 m2
boolean
C3811844 (UMLS CUI [1])
Complications
Item
patients with any of the following complications:
boolean
C0009566 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Cardiovascular Diseases Serious | Heart failure | Liver diseases | Liver Cirrhosis
Item
serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)
boolean
C0007222 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
Complications
Item
patients with any of the following complications or history thereof:
boolean
C0009566 (UMLS CUI [1])
Drug Allergy | Drug related anaphylaxis | Hypersensitivity Benzazepine derivatives | Hypersensitivity Suspected Benzazepine derivatives
Item
clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity
boolean
C0013182 (UMLS CUI [1])
C0850607 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0005034 (UMLS CUI [3,2])
C0243072 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0005034 (UMLS CUI [4,3])
C0243072 (UMLS CUI [4,4])
Mental disorders Informed Consent Unable
Item
inability to personally give consent due to a mental illness
boolean
C0004936 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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