ID
36914
Description
Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This documen contains the Laboratory Collections for Screening form.
Keywords
Versions (2)
- 9/1/17 9/1/17 -
- 6/21/19 6/21/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 21, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201
Laboratory Collections for Screening
- StudyEvent: ODM
Description
Clinical chemistry and haematology
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0018941
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
laboratory findings blood sampling
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0005834
Description
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
If ‘Yes’, please record diagnosis on Baseline Signs and Symptoms page.
Data type
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0042014
Description
Drug Screening (Urine)
Alias
- UMLS CUI-1
- C0202274
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Description
If ‘Yes’, please withdraw subject and record all the relevant contra-indicated drugs below.
Data type
text
Alias
- UMLS CUI [1,1]
- C1301624
- UMLS CUI [1,2]
- C0013227
Description
Type of Drug
Data type
text
Alias
- UMLS CUI [1]
- C0457591
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
HIV and Hepatitis B and C
Alias
- UMLS CUI-1
- C0019682
- UMLS CUI-2
- C0019163
- UMLS CUI-3
- C0019196
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0011008
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Description
If positive please withdraw the subject from the study.
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Pregnancy test
Alias
- UMLS CUI-1
- C0032976
Description
Pregnancy test performance
Data type
text
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C1518965
Description
No test performance, reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C3841220
- UMLS CUI [1,3]
- C0032976
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032976
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0032976
Description
Pregnancy test result
Data type
text
Alias
- UMLS CUI [1]
- C0427777
Description
Dipstick urine HCG
Data type
text
Alias
- UMLS CUI [1]
- C1254846
Description
Serum HCG
Data type
text
Alias
- UMLS CUI [1]
- C2348195
Description
Other pregnancy test types
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0032976
- UMLS CUI [1,3]
- C0332307
Description
Laboratory name
Data type
text
Alias
- UMLS CUI [1]
- C0022877
Description
Alcohol test
Alias
- UMLS CUI-1
- C0202304
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032976
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0032976
Description
Alcohol test finding
Data type
text
Alias
- UMLS CUI [1]
- C0495718
Similar models
Laboratory Collections for Screening
- StudyEvent: ODM
C0018941 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0019163 (UMLS CUI-2)
C0019196 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1518965 (UMLS CUI [1,2])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0032976 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,2])