ID

20662

Description

Documentation Part: Liver Events Assessment 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. 3/9/17 3/9/17 -
Uploaded on

March 9, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

English

Liver Events Assessment 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
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C1556667
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Description

If Yes, stop investigational product, complete date stopped on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following tests: • PK blood sample within 24 hours of last dose (or 3x the investigational product half-life or t1/2). • Hepatitis A: Hepatitis A lgM antibody. • Hepatitis B: Hepatitis B surface antigen and Hepatitis B Core Antibody (lgM). • Hepatitis C: Hepatitis C RNA. • Hepatitis E IgM antibody (if subject resides or has travelled in past 3 months outside the USA or Canada). • Cytomegalovirus IgM antibody (CMV) • EBV (Epstein Barr viral capsid antigen IgM antibody) or if unavailable, obtain heterophile antibody or monospot testing. • CPK (serum creatine phosphokinase) • LDH (lactate dehydrogenase) • Bilirubin fractionation, if bilirubin >1.5xULN The following are only needed when ALT >3xULN and bilirubin >1.5xULN (>35% direct) • Anti-nuclear antibody • Anti-smooth muscle antibody • Type 1 anti-liver kidney microsomal antibodies (if available) • Liver Imaging (ultrasound, magnetic resonance, or computerised tomography)

Data type

text

Alias
UMLS CUI [1,1]
C0023901
UMLS CUI [1,2]
C1556667
Back to the top of the page

Similar models

Liver Events Assessment 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])
Item Group
Liver Events Assessment
C1556667 (UMLS CUI-1)
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
text
C0023901 (UMLS CUI [1,1])
C1556667 (UMLS CUI [1,2])
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Code List
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
Yes (Y)
CL Item
No (N)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial