ID

36909

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 Laboratory Collections, Urinalaysis and Pregnancy test for follow-up form. It has to be filled in at Follow-up.

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Versionen (2)
  1. 05.09.17 05.09.17 -
  2. 21.06.19 21.06.19 -
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GlaxoSmithKline

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21. Juni 2019

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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

Englisch

Laboratory Collections, Urinalaysis, Pregnancy test follow-up

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

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

Laboratory Collection - Clinical chemistry and haematology

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C0008000
UMLS CUI-3
C0018941
Date of blood sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Time of blood sample taken
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Comments:
Beschreibung

Comments

Datentyp

text

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

If ‘Yes’, please record diagnosis on Adverse Event page.

Datentyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0243095
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0243095
Laboratory Collection - Urinalysis
Beschreibung

Laboratory Collection - Urinalysis

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0022877
Date of urine sample taken
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Time of urine sample taken
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Comments:
Beschreibung

Comments

Datentyp

text

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

If ‘Yes’, please record diagnosis on Adverse Event page.

Datentyp

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0243095
Pregnancy test
Beschreibung

Pregnancy test

Alias
UMLS CUI-1
C0032976
Was a pregnancy test carried out?
Beschreibung

Pregnancy test performance

Datentyp

text

Alias
UMLS CUI [1,1]
C1518965
UMLS CUI [1,2]
C0032976
If test was not performed, please specify reason
Beschreibung

No test performance

Datentyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3841220
UMLS CUI [1,3]
C0032976
If test was performed, please specify date of test
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
If test was performed, please specify time of test
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0032976
Pregnancy test result
Beschreibung

Pregnancy test result

Datentyp

text

Alias
UMLS CUI [1]
C0427777
Pregnancy test type
Beschreibung

Pregnancy test type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0332307
If other Pregnancy test type, please specify
Beschreibung

Other Pregnancy test type

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0032976
UMLS CUI [1,3]
C0332307
Laboratory name, if applicable
Beschreibung

Ensure result is included on laboratory report

Datentyp

text

Alias
UMLS CUI [1]
C3258037
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Ähnliche Modelle

Laboratory Collections, Urinalaysis, Pregnancy test follow-up

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Laboratory Collection - Clinical chemistry and haematology
C0022877 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0018941 (UMLS CUI-3)
Date of blood sample taken
Item
Date of blood sample taken
date
C1302413 (UMLS CUI [1])
Time of blood sample taken
Item
Time of blood sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
text
C0008000 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0018941 (UMLS CUI [2,1])
C0243095 (UMLS CUI [2,2])
Clinical chemistry and haematology findings
Code List
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Laboratory Collection - Urinalysis
C0042014 (UMLS CUI-1)
C0022877 (UMLS CUI-2)
Date of urine sample taken
Item
Date of urine sample taken
date
C1302413 (UMLS CUI [1])
Time of urine sample taken
Item
Time of urine sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
text
C0042014 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Clinical chemistry and haematology findings
Code List
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Pregnancy test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test carried out?
text
C1518965 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Pregnancy test performance
Code List
Was a pregnancy test carried out?
CL Item
Yes (Y)
CL Item
No (N)
No test performance
Item
If test was not performed, please specify reason
text
C0566251 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
Date of pregnancy test
Item
If test was performed, please specify date of test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of pregnancy test
Item
If test was performed, please specify time of test
time
C0040223 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item
Pregnancy test result
text
C0427777 (UMLS CUI [1])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (P)
CL Item
Negative (N)
Item
Pregnancy test type
integer
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Pregnancy test type
Code List
Pregnancy test type
CL Item
Dipstick urine HCG (1)
CL Item
Serum HCG (2)
CL Item
Other (3)
Other Pregnancy test type
Item
If other Pregnancy test type, please specify
text
C0205394 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Laboratory name
Item
Laboratory name, if applicable
text
C3258037 (UMLS CUI [1])
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