ID

36093

Beschrijving

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the pregnancy test form. It has to be filled in for all sessions each for day 1 and for follow-up.

Trefwoorden

Versies (1)
  1. 15-04-19 15-04-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 april 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Engels

Pregnancy Test

1 Formulieren  
  1. StudyEvent: ODM
    1. Pregnancy Test
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschrijving

Subject No.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschrijving

Panel ID

Datatype

text

Alias
UMLS CUI [1]
C3846158
Visit type
Beschrijving

Visit type

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Pregnancy Test
Beschrijving

Pregnancy Test

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

Pregnancy test

Datatype

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1272682
If no pregnancy test, please specify reason
Beschrijving

No pregnancy test, reason

Datatype

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3841220
UMLS CUI [1,3]
C0032976
If pregnancy test, please note Date of test
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
If pregnancy test, please note Time of test
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0040223
Pregnancy test Result
Beschrijving

If 'Positive', DO NOT include the subject in the study.

Datatype

text

Alias
UMLS CUI [1]
C0427777
Test type
Beschrijving

Please mark box for test type

Datatype

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0332307
If Other test type, please specify
Beschrijving

Other pregnancy test

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0032976
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Similar models

Pregnancy Test

1 Formulieren
  1. StudyEvent: ODM
    1. Pregnancy Test
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Session 1 day 1 (1)
CL Item
Session 2 day 1  (2)
CL Item
Session 3 day 1 (3)
CL Item
Session 4 day 1 (4)
CL Item
Session 5 day 1 (5)
CL Item
Follow-up (6)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test carried out?
text
C0032976 (UMLS CUI [1,1])
C1272682 (UMLS CUI [1,2])
Pregnancy test
Code List
Was a pregnancy test carried out?
CL Item
Yes (Y)
CL Item
No (N)
No pregnancy test, reason
Item
If no pregnancy test, 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 pregnancy test, please note Date of test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of pregnancy test
Item
If pregnancy test, please note Time of test
time
C0032976 (UMLS CUI [1,1])
C0040223 (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
Test type
integer
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Test type
Code List
Test type
CL Item
Dipstick urine HCG (1)
CL Item
Serum HCG (2)
CL Item
Other (3)
Other pregnancy test
Item
If Other test type, please specify
text
C0205394 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

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