ID

36124

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Follow-Up Physical Examination form. It has to be filled in for follow-up.

Keywords

Versions (1)
  1. 4/16/19 4/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 16, 2019

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License

Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

English

Follow-Up Physical Examination

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment:
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2985720
Time of Assessment
Description

00.00-23:59

Data type

time

Alias
UMLS CUI [1]
C2826761
Has there been any change from the last examination (screening)?
Description

Change from last examination

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0443172
If there has been any change from the last examination, please record in this item. Any clinically relevant worsening since the last exam must be record on the Adverse Events page.
Description

Change, specification

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0034869
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Similar models

Follow-Up Physical Examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment:
date
C2985720 (UMLS CUI [1])
Time of Assessment
Item
Time of Assessment
time
C2826761 (UMLS CUI [1])
Item
Has there been any change from the last examination (screening)?
text
C0031809 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Change from last examination
Code List
Has there been any change from the last examination (screening)?
CL Item
Yes (Y)
CL Item
No (N)
Change, specification
Item
If there has been any change from the last examination, please record in this item. Any clinically relevant worsening since the last exam must be record on the Adverse Events page.
text
C0031809 (UMLS CUI [1,1])
C0034869 (UMLS CUI [1,2])
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