ID

42723

Description

Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function; ODM derived from: https://clinicaltrials.gov/show/NCT01507389

Link

https://clinicaltrials.gov/show/NCT01507389

Keywords

Versions (3)
  1. 3/15/17 3/15/17 -
  2. 3/15/17 3/15/17 -
  3. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01507389

English

Eligibility Diabetes NCT01507389

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01507389
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with normal hepatic function and liver parameters within normal range
Description

Liver function | Liver parameters Normal Range

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C0449381
UMLS CUI [2,3]
C0086715
subjects with stable hepatic impairment classified as child-pugh grade a, b or c
Description

Hepatic impairment Stable Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C4050412
body mass index between 18.5-40.0 kg/m^2 (both inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to trial product or related products
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
liver transplanted subjects
Description

Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1]
C0023911
cardiac problems
Description

cardiac problem

Data type

boolean

Alias
UMLS CUI [1]
C0262402
uncontrolled treated/untreated hypertension
Description

Uncontrolled hypertension Treated | Uncontrolled hypertension untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
signs of acute liver insufficiency
Description

Hepatic Insufficiency Signs

Data type

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0311392
positive hiv (human immunodeficiency virus) 1+2 antibodies
Description

HIV antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0920548
cancer or any clinically significant disease or disorder except for conditions associated with the hepatic impairment
Description

Malignant Neoplasm | Disease Clinical Significance | Condition Associated with Hepatic impairment

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0948807
impaired renal function
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
Description

Tobacco use Number of cigarettes per day | Tobacco Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
UMLS CUI [2,1]
C0040329
UMLS CUI [2,2]
C0205163
habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
Description

Consumption Excessive Beverages methylxanthine | Consumption Excessive Food methylxanthine | Consumption Excessive Coffee | Consumption Excessive Tea | Consumption Excessive Soft Drinks | Consumption Excessive Cola drink | Consumption Excessive Hot chocolate drink

Data type

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C0005329
UMLS CUI [1,4]
C0066447
UMLS CUI [2,1]
C0009830
UMLS CUI [2,2]
C0442802
UMLS CUI [2,3]
C0016452
UMLS CUI [2,4]
C0066447
UMLS CUI [3,1]
C0009830
UMLS CUI [3,2]
C0442802
UMLS CUI [3,3]
C0009237
UMLS CUI [4,1]
C0009830
UMLS CUI [4,2]
C0442802
UMLS CUI [4,3]
C0039400
UMLS CUI [5,1]
C0009830
UMLS CUI [5,2]
C0442802
UMLS CUI [5,3]
C3489624
UMLS CUI [6,1]
C0009830
UMLS CUI [6,2]
C0442802
UMLS CUI [6,3]
C0452444
UMLS CUI [7,1]
C0009830
UMLS CUI [7,2]
C0442802
UMLS CUI [7,3]
C0452243
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Similar models

Eligibility Diabetes NCT01507389

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01507389
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver function | Liver parameters Normal Range
Item
subjects with normal hepatic function and liver parameters within normal range
boolean
C0232741 (UMLS CUI [1])
C0023884 (UMLS CUI [2,1])
C0449381 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,3])
Hepatic impairment Stable Child-Pugh Classification
Item
subjects with stable hepatic impairment classified as child-pugh grade a, b or c
boolean
C0948807 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C4050412 (UMLS CUI [1,3])
Body mass index
Item
body mass index between 18.5-40.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Transplantation of liver
Item
liver transplanted subjects
boolean
C0023911 (UMLS CUI [1])
cardiac problem
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
Uncontrolled hypertension Treated | Uncontrolled hypertension untreated
Item
uncontrolled treated/untreated hypertension
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Hepatic Insufficiency Signs
Item
signs of acute liver insufficiency
boolean
C1306571 (UMLS CUI [1,1])
C0311392 (UMLS CUI [1,2])
HIV antibody positive
Item
positive hiv (human immunodeficiency virus) 1+2 antibodies
boolean
C0920548 (UMLS CUI [1])
Malignant Neoplasm | Disease Clinical Significance | Condition Associated with Hepatic impairment
Item
cancer or any clinically significant disease or disorder except for conditions associated with the hepatic impairment
boolean
C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0348080 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0948807 (UMLS CUI [3,3])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Tobacco use Number of cigarettes per day | Tobacco Equivalent
Item
smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0040329 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Consumption Excessive Beverages methylxanthine | Consumption Excessive Food methylxanthine | Consumption Excessive Coffee | Consumption Excessive Tea | Consumption Excessive Soft Drinks | Consumption Excessive Cola drink | Consumption Excessive Hot chocolate drink
Item
habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
boolean
C0009830 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0005329 (UMLS CUI [1,3])
C0066447 (UMLS CUI [1,4])
C0009830 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
C0016452 (UMLS CUI [2,3])
C0066447 (UMLS CUI [2,4])
C0009830 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0009237 (UMLS CUI [3,3])
C0009830 (UMLS CUI [4,1])
C0442802 (UMLS CUI [4,2])
C0039400 (UMLS CUI [4,3])
C0009830 (UMLS CUI [5,1])
C0442802 (UMLS CUI [5,2])
C3489624 (UMLS CUI [5,3])
C0009830 (UMLS CUI [6,1])
C0442802 (UMLS CUI [6,2])
C0452444 (UMLS CUI [6,3])
C0009830 (UMLS CUI [7,1])
C0442802 (UMLS CUI [7,2])
C0452243 (UMLS CUI [7,3])
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