ID

36915

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 document contains the Unscheduled Laboratory Collections for Screening form. It has to be filled in if there is an unscheduled measurement.

Keywords

  1. 9/1/17 9/1/17 -
  2. 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

Unscheduled Laboratory Collections for Screening

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Description

identification number

Data type

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Clinical chemistry and haematology
Description

Clinical chemistry and haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Date of blood sampling
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of blood sampling
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0040223
Comments:
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Description

laboratory findings blood sampling

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0005834
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
Date of blood sampling
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Time of blood sampling
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0040223
Comments:
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Description

laboratory findings urinalysis

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0042014

Similar models

Unscheduled Laboratory Collections for Screening

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
identification number
Item
Volunteer panel number
integer
C1300638 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Clinical chemistry and haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of blood sampling
Item
Time of blood sampling
time
C0178913 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
text
C0022877 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Code List
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of blood sampling
Item
Time of blood sampling
time
C0178913 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
text
C0022877 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Code List
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
CL Item
Yes (Y)
CL Item
No (N)

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