ID

44611

Description

Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function; ODM derived from: https://clinicaltrials.gov/show/NCT02210871

Link

https://clinicaltrials.gov/show/NCT02210871

Keywords

  1. 3/23/19 3/23/19 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes NCT02210871

Eligibility Diabetes NCT02210871

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02210871
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age at least 18 years at the time of signing informed consent
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
body mass index (bmi) 18.5-40.0 kg/m^2 (both inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
only for subjects with hepatic impairment (mild, moderate and severe): a diagnosis of cirrhosis due to parenchymal liver disease, classified as child-pugh grade a,b or c as assessed by investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound,computerised axial tomography (ct) scan, magnetic resonance imaging (mri), and/or liver biopsy
Description

Hepatic impairment Mild | Hepatic impairment Moderate | Hepatic impairment Severe | Liver Cirrhosis Due to Parenchymal liver disease | Child-Pugh Classification | Medical History | Physical Examination | Ultrasonography of liver | CT scan | Magnetic Resonance Imaging | Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0948807
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0745745
UMLS CUI [5]
C4050412
UMLS CUI [6]
C0262926
UMLS CUI [7]
C0031809
UMLS CUI [8]
C0412534
UMLS CUI [9]
C0040405
UMLS CUI [10]
C0024485
UMLS CUI [11]
C0193388
only for subjects with normal hepatic function: subjects who are judged to be in good general health based on physical examination, medical history, ecg, vital signs, and the results of biochemistry, coagulation, haematology tests and urinalysis performed during the screening visit, as judged by the investigator
Description

Normal liver function | General health good | Physical Examination | Medical History | Electrocardiography | Vital signs | Biochemical finding | Blood coagulation tests | Hematologic Tests | Urinalysis

Data type

boolean

Alias
UMLS CUI [1]
C1848676
UMLS CUI [2]
C1277245
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0262926
UMLS CUI [5]
C1623258
UMLS CUI [6]
C0518766
UMLS CUI [7]
C0428132
UMLS CUI [8]
C0005790
UMLS CUI [9]
C0018941
UMLS CUI [10]
C0042014
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including the follow-up period (adequate contraceptive measures as required by local regulation or practice)
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg). if white-coat hypertension is suspected at the screening visit a repeated measurement at the screening visit is allowed
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | White Coat Hypertension Suspected

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0262534
UMLS CUI [4,2]
C0750491
mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with trial procedures
Description

Mental handicap Excludes Comprehension Study Protocol | Comprehension Study Protocol Unwilling | Language Barrier Excludes Comprehension Study Protocol | Mental handicap Excludes Protocol Compliance | Protocol Compliance Unwilling | Language Barrier Excludes Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0237167
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0162340
UMLS CUI [3,4]
C2348563
UMLS CUI [4,1]
C1306341
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0525058
UMLS CUI [5,2]
C0558080
UMLS CUI [6,1]
C0237167
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C0525058
donation of any blood or plasma in the past month or in excess of 400 ml within the 3 months preceding screening, or surgery or trauma with more than 400 ml blood loss within the 3 months preceding screening
Description

Blood Donation | Plasma Donation | Blood Donation Excessive | Plasma Donation Excessive | Operative Surgical Procedures Blood Loss Amount | Trauma Blood Loss Amount

Data type

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0680854
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C0442802
UMLS CUI [4,1]
C0032105
UMLS CUI [4,2]
C0680854
UMLS CUI [4,3]
C0442802
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C3163616
UMLS CUI [5,3]
C1265611
UMLS CUI [6,1]
C3714660
UMLS CUI [6,2]
C3163616
UMLS CUI [6,3]
C1265611

Similar models

Eligibility Diabetes NCT02210871

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02210871
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
male or female, age at least 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) 18.5-40.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hepatic impairment Mild | Hepatic impairment Moderate | Hepatic impairment Severe | Liver Cirrhosis Due to Parenchymal liver disease | Child-Pugh Classification | Medical History | Physical Examination | Ultrasonography of liver | CT scan | Magnetic Resonance Imaging | Biopsy of liver
Item
only for subjects with hepatic impairment (mild, moderate and severe): a diagnosis of cirrhosis due to parenchymal liver disease, classified as child-pugh grade a,b or c as assessed by investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound,computerised axial tomography (ct) scan, magnetic resonance imaging (mri), and/or liver biopsy
boolean
C0948807 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0948807 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0948807 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0745745 (UMLS CUI [4,3])
C4050412 (UMLS CUI [5])
C0262926 (UMLS CUI [6])
C0031809 (UMLS CUI [7])
C0412534 (UMLS CUI [8])
C0040405 (UMLS CUI [9])
C0024485 (UMLS CUI [10])
C0193388 (UMLS CUI [11])
Normal liver function | General health good | Physical Examination | Medical History | Electrocardiography | Vital signs | Biochemical finding | Blood coagulation tests | Hematologic Tests | Urinalysis
Item
only for subjects with normal hepatic function: subjects who are judged to be in good general health based on physical examination, medical history, ecg, vital signs, and the results of biochemistry, coagulation, haematology tests and urinalysis performed during the screening visit, as judged by the investigator
boolean
C1848676 (UMLS CUI [1])
C1277245 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C0518766 (UMLS CUI [6])
C0428132 (UMLS CUI [7])
C0005790 (UMLS CUI [8])
C0018941 (UMLS CUI [9])
C0042014 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including the follow-up period (adequate contraceptive measures as required by local regulation or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | White Coat Hypertension Suspected
Item
uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg). if white-coat hypertension is suspected at the screening visit a repeated measurement at the screening visit is allowed
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0262534 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Mental handicap Excludes Comprehension Study Protocol | Comprehension Study Protocol Unwilling | Language Barrier Excludes Comprehension Study Protocol | Mental handicap Excludes Protocol Compliance | Protocol Compliance Unwilling | Language Barrier Excludes Protocol Compliance
Item
mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with trial procedures
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0237167 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0162340 (UMLS CUI [3,3])
C2348563 (UMLS CUI [3,4])
C1306341 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0525058 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C0237167 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Blood Donation | Plasma Donation | Blood Donation Excessive | Plasma Donation Excessive | Operative Surgical Procedures Blood Loss Amount | Trauma Blood Loss Amount
Item
donation of any blood or plasma in the past month or in excess of 400 ml within the 3 months preceding screening, or surgery or trauma with more than 400 ml blood loss within the 3 months preceding screening
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0680854 (UMLS CUI [4,2])
C0442802 (UMLS CUI [4,3])
C0543467 (UMLS CUI [5,1])
C3163616 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C3714660 (UMLS CUI [6,1])
C3163616 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])

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