ID

21077

Description

Documentation Part: Liver Events An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Link

https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1

Keywords

Versions (1)
  1. 4/8/17 4/8/17 -
Uploaded on

April 8, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Liver Events Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

English

Liver Events Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms  
Subject information
Description

Subject information

Alias
UMLS CUI-1
C2707520
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Date of assessment
Description

Date of assessment

Alias
UMLS CUI-1
C2985720
UMLS CUI-2
C1556667
Date of assessment
Description

Date of assessment

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1556667
Day Month Year
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Description

Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?

Alias
UMLS CUI-1
C0023901
ALT (alanine aminotransferase)
Description

ALT (alanine aminotransferase)

Data type

boolean

Alias
UMLS CUI [1]
C0201836
AST (aspartate aminotransferase)
Description

AST (aspartate aminotransferase)

Data type

boolean

Alias
UMLS CUI [1]
C0201899
Total bilirubin
Description

Total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201913
Alkaline phosphatase
Description

Alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0201850
Other
Description

Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0023901
Liver events
Description

Liver events

Alias
UMLS CUI-1
C1556667
Is the subject age 55 or older?
Description

Is the subject age 55 or older?

Data type

boolean

Alias
UMLS CUI [1]
C2348575
If female, is the subject pregnant?
Description

If Yes, ensure Pregnancy Notification Form has been completed.

Data type

text

Alias
UMLS CUI [1]
C0032961
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Description

Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C1711359
If Yes, were the results normal?
Description

If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1274040
Were any liver biopsies performed?
Description

If Yes, complete Liver Biopsy form.

Data type

boolean

Alias
UMLS CUI [1]
C0193388
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Description

If Yes, record on the appropriate Concomitant Medication form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0002346
UMLS CUI [1,2]
C0242295
UMLS CUI [1,3]
C0281875
Did the subject fast or undergo significant dietary change in the past week?
Description

Did the subject fast or undergo significant dietary change in the past week?

Data type

boolean

Alias
UMLS CUI [1]
C3671772
Was a pharmacokinetic blood sample obtained?
Description

An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1/2;).

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0178913
If Yes, date and time sample taken
Description

If Yes, date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
If Yes, date and time of last investigational product dose prior to PK sample
Description

If Yes, date and time of last investigational product dose prior to PK sample

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0678766
Alcohol intake
Description

Alcohol intake

Alias
UMLS CUI-1
C0001948
Record the average number of units of alcohol consumed per week
Description

Record the average number of units of alcohol consumed per week

Data type

integer

Measurement units
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0556604
units per week
Liver disease medical conditions
Description

Liver disease medical conditions

Alias
UMLS CUI-1
C0023895
Acute Viral Hepatitis A
Description

Acute Viral Hepatitis A

Data type

text

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Description

Chronic Hepatitis B

Data type

text

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Description

Chronic Hepatitis C

Data type

text

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Description

Cytomegalovirus Hepatitis

Data type

text

Alias
UMLS CUI [1]
C0276252
Epstein Barr Virus Infectious Mononucleosis
Description

Epstein Barr Virus Infectious Mononucleosis

Data type

text

Alias
UMLS CUI [1,1]
C0021345
UMLS CUI [1,2]
C0014644
Herpes Simplex Hepatitis
Description

Herpes Simplex Hepatitis

Data type

text

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Description

Alcoholic Liver Disease

Data type

text

Alias
UMLS CUI [1]
C0023896
Non-alcoholic Steatohepatitis
Description

Non-alcoholic Steatohepatitis

Data type

text

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Description

Fatty Liver

Data type

text

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Description

Hepatic Cirrhosis

Data type

text

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Description

Hemochromatosis

Data type

text

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Description

Autoimmune Hepatitis

Data type

text

Alias
UMLS CUI [1]
C0241910
Gallbladder disease or biliary disease
Description

Gallbladder disease or biliary disease

Data type

text

Alias
UMLS CUI [1,1]
C0016977
UMLS CUI [1,2]
C3275124
Drug related liver disease conditions (All drugs including Investigational Product)
Description

Drug related liver disease conditions (All drugs including Investigational Product)

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0277579
Drug related liver disease
Description

Drug related liver disease

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Other liver disease conditions
Description

Other liver disease conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
Specific condition
Description

Specific condition

Data type

text

Alias
UMLS CUI [1]
C0012634
Other medical conditions
Description

Other medical conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0205394
Drug allergies
Description

Drug allergies

Data type

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
Rheumatoid Arthritis
Description

Rheumatoid Arthritis

Data type

text

Alias
UMLS CUI [1]
C0003873
Psoriasis
Description

Psoriasis

Data type

text

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Description

Thyroid Disease

Data type

text

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Description

Inflammatory Bowel Disease

Data type

text

Alias
UMLS CUI [1]
C0021390
Lupus
Description

Lupus

Data type

text

Alias
UMLS CUI [1]
C0409974
Sjogrens Syndrome
Description

Sjogrens Syndrome

Data type

text

Alias
UMLS CUI [1]
C1527336
Vitiligo
Description

Vitiligo

Data type

text

Alias
UMLS CUI [1]
C0042900
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Similar models

Liver Events Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject information
C2707520 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Date of assessment
C2985720 (UMLS CUI-1)
C1556667 (UMLS CUI-2)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1,1])
C1556667 (UMLS CUI [1,2])
Item Group
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
C0023901 (UMLS CUI-1)
ALT (alanine aminotransferase)
Item
ALT (alanine aminotransferase)
boolean
C0201836 (UMLS CUI [1])
AST (aspartate aminotransferase)
Item
AST (aspartate aminotransferase)
boolean
C0201899 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
boolean
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
boolean
C0201850 (UMLS CUI [1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C0023901 (UMLS CUI [1,2])
Item Group
Liver events
C1556667 (UMLS CUI-1)
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
C2348575 (UMLS CUI [1])
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
If female, is the subject pregnant?
Code List
If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1711359 (UMLS CUI [1,3])
If Yes, were the results normal?
Item
If Yes, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Were any liver biopsies performed?
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C0002346 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
Did the subject fast or undergo significant dietary change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1])
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0031328 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
If Yes, date and time sample taken
Item
If Yes, date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
If Yes, date and time of last investigational product dose prior to PK sample
Item
If Yes, date and time of last investigational product dose prior to PK sample
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Record the average number of units of alcohol consumed per week
Item
Record the average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0556604 (UMLS CUI [1,2])
Item Group
Liver disease medical conditions
C0023895 (UMLS CUI-1)
Item
Acute Viral Hepatitis A
text
C0276434 (UMLS CUI [1])
undefined item
Code List
Acute Viral Hepatitis A
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis B
text
C0524909 (UMLS CUI [1])
undefined item
Code List
Chronic Hepatitis B
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis C
text
C0524910 (UMLS CUI [1])
undefined item
Code List
Chronic Hepatitis C
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Cytomegalovirus Hepatitis
text
C0276252 (UMLS CUI [1])
undefined item
Code List
Cytomegalovirus Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Epstein Barr Virus Infectious Mononucleosis
text
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
undefined item
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Herpes Simplex Hepatitis
text
C1963747 (UMLS CUI [1])
undefined item
Code List
Herpes Simplex Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Alcoholic Liver Disease
text
C0023896 (UMLS CUI [1])
undefined item
Code List
Alcoholic Liver Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Non-alcoholic Steatohepatitis
text
C3241937 (UMLS CUI [1])
undefined item
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Fatty Liver
text
C0015695 (UMLS CUI [1])
undefined item
Code List
Fatty Liver
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hepatic Cirrhosis
text
C0023890 (UMLS CUI [1])
undefined item
Code List
Hepatic Cirrhosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hemochromatosis
text
C0018995 (UMLS CUI [1])
undefined item
Code List
Hemochromatosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Autoimmune Hepatitis
text
C0241910 (UMLS CUI [1])
undefined item
Code List
Autoimmune Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Gallbladder disease or biliary disease
text
C0016977 (UMLS CUI [1,1])
C3275124 (UMLS CUI [1,2])
undefined item
Code List
Gallbladder disease or biliary disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Drug related liver disease conditions (All drugs including Investigational Product)
C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)
Item
Drug related liver disease
text
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Drug related liver disease
Code List
Drug related liver disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Other liver disease conditions
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Specific condition
text
C0012634 (UMLS CUI [1])
Specific condition
Code List
Specific condition
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Drug allergies
text
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
undefined item
Code List
Drug allergies
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Rheumatoid Arthritis
text
C0003873 (UMLS CUI [1])
undefined item
Code List
Rheumatoid Arthritis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Psoriasis
text
C0033860 (UMLS CUI [1])
undefined item
Code List
Psoriasis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Thyroid Disease
text
C0040128 (UMLS CUI [1])
undefined item
Code List
Thyroid Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Inflammatory Bowel Disease
text
C0021390 (UMLS CUI [1])
undefined item
Code List
Inflammatory Bowel Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Lupus
text
C0409974 (UMLS CUI [1])
undefined item
Code List
Lupus
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Sjogrens Syndrome
text
C1527336 (UMLS CUI [1])
undefined item
Code List
Sjogrens Syndrome
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Vitiligo
text
C0042900 (UMLS CUI [1])
undefined item
Code List
Vitiligo
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
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