ID

21077

Beskrivning

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

Länk

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

Nyckelord

Versioner (1)
  1. 2017-04-08 2017-04-08 -
Uppladdad den

8 april 2017

DOI

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Licens

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

Engelsk

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

1 Formulär  
Subject information
Beskrivning

Subject information

Alias
UMLS CUI-1
C2707520
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beskrivning

Centre Number

Datatyp

text

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

Date of assessment

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

Date of assessment

Datatyp

date

Måttenheter
  • 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?
Beskrivning

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

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

ALT (alanine aminotransferase)

Datatyp

boolean

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

AST (aspartate aminotransferase)

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
Total bilirubin
Beskrivning

Total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0201913
Alkaline phosphatase
Beskrivning

Alkaline phosphatase

Datatyp

boolean

Alias
UMLS CUI [1]
C0201850
Other
Beskrivning

Other

Datatyp

boolean

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

Liver events

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

Is the subject age 55 or older?

Datatyp

boolean

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

If Yes, ensure Pregnancy Notification Form has been completed.

Datatyp

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)?
Beskrivning

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)?

Datatyp

boolean

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

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

Datatyp

boolean

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

If Yes, complete Liver Biopsy form.

Datatyp

boolean

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

If Yes, record on the appropriate Concomitant Medication form.

Datatyp

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?
Beskrivning

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

Datatyp

boolean

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

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

Datatyp

boolean

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

If Yes, date and time sample taken

Datatyp

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
Beskrivning

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

Datatyp

datetime

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

Alcohol intake

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

Record the average number of units of alcohol consumed per week

Datatyp

integer

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

Liver disease medical conditions

Alias
UMLS CUI-1
C0023895
Acute Viral Hepatitis A
Beskrivning

Acute Viral Hepatitis A

Datatyp

text

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Beskrivning

Chronic Hepatitis B

Datatyp

text

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Beskrivning

Chronic Hepatitis C

Datatyp

text

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Beskrivning

Cytomegalovirus Hepatitis

Datatyp

text

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

Epstein Barr Virus Infectious Mononucleosis

Datatyp

text

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

Herpes Simplex Hepatitis

Datatyp

text

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Beskrivning

Alcoholic Liver Disease

Datatyp

text

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

Non-alcoholic Steatohepatitis

Datatyp

text

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Beskrivning

Fatty Liver

Datatyp

text

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Beskrivning

Hepatic Cirrhosis

Datatyp

text

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Beskrivning

Hemochromatosis

Datatyp

text

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Beskrivning

Autoimmune Hepatitis

Datatyp

text

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

Gallbladder disease or biliary disease

Datatyp

text

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

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

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

Drug related liver disease

Datatyp

text

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

Other liver disease conditions

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

Specific condition

Datatyp

text

Alias
UMLS CUI [1]
C0012634
Other medical conditions
Beskrivning

Other medical conditions

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

Drug allergies

Datatyp

text

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

Rheumatoid Arthritis

Datatyp

text

Alias
UMLS CUI [1]
C0003873
Psoriasis
Beskrivning

Psoriasis

Datatyp

text

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Beskrivning

Thyroid Disease

Datatyp

text

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Beskrivning

Inflammatory Bowel Disease

Datatyp

text

Alias
UMLS CUI [1]
C0021390
Lupus
Beskrivning

Lupus

Datatyp

text

Alias
UMLS CUI [1]
C0409974
Sjogrens Syndrome
Beskrivning

Sjogrens Syndrome

Datatyp

text

Alias
UMLS CUI [1]
C1527336
Vitiligo
Beskrivning

Vitiligo

Datatyp

text

Alias
UMLS CUI [1]
C0042900
Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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