ID

36915

Descripción

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.

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Versiones (2)
  1. 1/9/17 1/9/17 -
  2. 21/6/19 21/6/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 de junio de 2019

DOI

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Licencia

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

Inglés

Unscheduled Laboratory Collections for Screening

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Descripción

identification number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Descripción

Subject number

Tipo de datos

integer

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

Clinical chemistry and haematology

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

day month year

Tipo de datos

date

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

00:00-23:59

Tipo de datos

time

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

Comments

Tipo de datos

text

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

laboratory findings blood sampling

Tipo de datos

text

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

Urinalysis

Alias
UMLS CUI-1
C0042014
Date of blood sampling
Descripción

day month year

Tipo de datos

date

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

00:00-23:59

Tipo de datos

time

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

Comments

Tipo de datos

text

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

laboratory findings urinalysis

Tipo de datos

text

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

Unscheduled Laboratory Collections for Screening

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
laboratory findings blood sampling
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])
laboratory findings urinalysis
Code List
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
CL Item
Yes (Y)
CL Item
No (N)
Volver a la parte superior de la página 

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