ID

36004

Beschreibung

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 Demographic Details and demography for females form. It has to be filled in for screening.

Stichworte

Versionen (1)
  1. 09.04.19 09.04.19 -
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GlaxoSmithKline

Hochgeladen am

9. April 2019

DOI

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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Englisch

Demographic Details, demography for females

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschreibung

Subject No.

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschreibung

Panel ID

Datentyp

text

Alias
UMLS CUI [1]
C3846158
Visit Date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Demographic Details
Beschreibung

Demographic Details

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Height
Beschreibung

Body Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Body Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschreibung

Body mass index

Datentyp

float

Maßeinheiten
  • kg/m^2
Alias
UMLS CUI [1]
C1305855
kg/m^2
Clinical Staff Signature
Beschreibung

Clinical Staff Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C0025106
UMLS CUI [1,2]
C1519316
Date of signature
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Racial group
Beschreibung

Racial group

Alias
UMLS CUI-1
C0034510
American Hispanic
Beschreibung

American Hispanic race

Datentyp

boolean

Alias
UMLS CUI [1]
C0019576
Arabic/North African
Beschreibung

Arabic/North African race

Datentyp

boolean

Alias
UMLS CUI [1]
C0238604
Black race
Beschreibung

Black race

Datentyp

boolean

Alias
UMLS CUI [1]
C0005680
East and South East Asia
Beschreibung

East and South East Asian race

Datentyp

boolean

Alias
UMLS CUI [1]
C0003983
Japanese
Beschreibung

Japanese race

Datentyp

boolean

Alias
UMLS CUI [1]
C1556094
South Asia
Beschreibung

South Asian race

Datentyp

boolean

Alias
UMLS CUI [1]
C1519427
White/Caucasian
Beschreibung

White/Caucasian race

Datentyp

boolean

Alias
UMLS CUI [1]
C0043157
Other
Beschreibung

Other race

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0034510
If other race, please specify
Beschreibung

Other race, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0034510
UMLS CUI [1,3]
C2348235
Childbearing potential
Beschreibung

Childbearing potential

Alias
UMLS CUI-1
C3831118
Childbearing potential
Beschreibung

Tick one. If you tick Potentially able to conceive children: is she practising a clinically accepted method of contraception such as surgical sterilisation, LU .D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic

Datentyp

integer

Alias
UMLS CUI [1]
C3831118
Pregnancy Test
Beschreibung

Pregnancy Test

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

Pregnancy test

Datentyp

text

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

No pregnancy test, reason

Datentyp

text

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

day month year

Datentyp

date

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

00:00-23:59

Datentyp

time

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

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

Datentyp

text

Alias
UMLS CUI [1]
C0427777
Pregnancy test type
Beschreibung

Please tick box for 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
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Ähnliche Modelle

Demographic Details, demography for females

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demographic Details
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Clinical Staff Signature
Item
Clinical Staff Signature
text
C0025106 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Racial group
C0034510 (UMLS CUI-1)
American Hispanic race
Item
American Hispanic
boolean
C0019576 (UMLS CUI [1])
Arabic/North African race
Item
Arabic/North African
boolean
C0238604 (UMLS CUI [1])
Black race
Item
Black race
boolean
C0005680 (UMLS CUI [1])
East and South East Asian race
Item
East and South East Asia
boolean
C0003983 (UMLS CUI [1])
Japanese race
Item
Japanese
boolean
C1556094 (UMLS CUI [1])
South Asian race
Item
South Asia
boolean
C1519427 (UMLS CUI [1])
White/Caucasian race
Item
White/Caucasian
boolean
C0043157 (UMLS CUI [1])
Other race
Item
Other
text
C0205394 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Other race, specification
Item
If other race, please specify
text
C0205394 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Childbearing potential
C3831118 (UMLS CUI-1)
Item
Childbearing potential
integer
C3831118 (UMLS CUI [1])
Childbearing potential
Code List
Childbearing potential
CL Item
Premenarcheal (1)
CL Item
Sterile ( of childbearing age) (2)
CL Item
Postmenopausal (3)
CL Item
Potentially able to conceive children (4)
CL Item
contraception (i.e., Norplant) (5)
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 was performed, please note date of test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of pregnancy test
Item
If pregnancy test was performed, 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
Pregnancy test type
integer
C0032976 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Pregnancy test, test type
Code List
Pregnancy test type
CL Item
Dipstick urine HCG (1)
CL Item
SerurnHCG (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])
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