Informações:
Falhas:
ID
21077
Descrição
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
Palavras-chave
Versões (1)
- 08/04/2017 08/04/2017 -
Transferido a
8 de abril de 2017
DOI
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Licença
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
Liver Events Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Similar models
Liver Events Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
C0019994 (UMLS CUI [1,2])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1,1])
C1556667 (UMLS CUI [1,2])
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])
C0023901 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
C0040223 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
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])
C0556604 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
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])
C0014644 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
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])
C3275124 (UMLS CUI [1,2])
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)
C0277579 (UMLS CUI-2)
Item
Drug related liver disease
text
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
C0277579 (UMLS CUI [1,2])
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)
C0205394 (UMLS CUI-2)
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI-2)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)