ID

36915

Beschreibung

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.

Stichworte

Versionen (2)
  1. 01.09.17 01.09.17 -
  2. 21.06.19 21.06.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

21. Juni 2019

DOI

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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

Englisch

Unscheduled Laboratory Collections for Screening

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Volunteer panel number
Beschreibung

identification number

Datentyp

integer

Alias
UMLS CUI [1]
C1300638
Subject number
Beschreibung

Subject number

Datentyp

integer

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

Clinical chemistry and haematology

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

day month year

Datentyp

date

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

00:00-23:59

Datentyp

time

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

Comments

Datentyp

text

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

laboratory findings blood sampling

Datentyp

text

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

Urinalysis

Alias
UMLS CUI-1
C0042014
Date of blood sampling
Beschreibung

day month year

Datentyp

date

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

00:00-23:59

Datentyp

time

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

Comments

Datentyp

text

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

laboratory findings urinalysis

Datentyp

text

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

Unscheduled Laboratory Collections for Screening

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
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