ID
36125
Description
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 Notification Form form. Complete as may sections ofthis form for each subject who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail of fax (fax preferred) within two weeks ofleaming ofthepregnancy.After delivery complete the remaining sections and fax the form to GSK. Original pages should remain with the subject's Case Report From.
Mots-clés
Versions (2)
- 15/04/2019 15/04/2019 -
- 16/04/2019 16/04/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
16 avril 2019
DOI
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Licence
Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198
Pregnancy Notification Form
- StudyEvent: ODM
Description
Reporter Information
Alias
- UMLS CUI-1
- C3840395
Description
Reporter name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigators Title
Type de données
text
Alias
- UMLS CUI [1,1]
- C3888414
- UMLS CUI [1,2]
- C0008961
Description
Investigators Address
Type de données
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Description
Telephone No.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0008961
Description
Fax No.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1549619
- UMLS CUI [1,2]
- C0008961
Description
City, State/Province
Type de données
text
Alias
- UMLS CUI [1,1]
- C0008848
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [2,1]
- C1547742
- UMLS CUI [2,2]
- C0008961
Description
Postal Code
Type de données
text
Alias
- UMLS CUI [1,1]
- C1514254
- UMLS CUI [1,2]
- C0008961
Description
Country
Type de données
text
Alias
- UMLS CUI [1,1]
- C0454664
- UMLS CUI [1,2]
- C0008961
Description
Mother's relevant medical/family history
Alias
- UMLS CUI-1
- C0026591
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0241889
Description
(i.e. Include alcohol, tobacco and substance abuse, complications of past pregnancy, labor/delivery, fetus/baby, illnesses during this pregnancy, assisted conception specify, other disorders including familial birth defects/genetic/chromosomal disorders, method of diagnosis consanguinity etc.)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0026591
- UMLS CUI [2,2]
- C0241889
Description
Number of previous Pregnancies
Type de données
integer
Alias
- UMLS CUI [1]
- C3814420
Description
Number of previous Pregnancies
Type de données
integer
Alias
- UMLS CUI [1]
- C0151526
Description
Birth Termination
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1283212
- UMLS CUI [1,2]
- C0005615
Description
Father's relevant medical/family history
Alias
- UMLS CUI-1
- C0015671
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0241889
Description
Information provided
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1533716
- UMLS CUI [1,2]
- C1709908
Description
Information reported, other
Type de données
text
Alias
- UMLS CUI [1,1]
- C1533716
- UMLS CUI [1,2]
- C1709908
- UMLS CUI [1,3]
- C0205394
Description
(i.e, Include chronic illnesses: specify, familial birth defects/genetic/chromosomal disorders,habitual exposure: specify, alcohol/tobacco, drug exposure: specify, substance abuse and medication use)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0015671
- UMLS CUI [2,2]
- C0241889
Description
Father Unknown
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Description
Number of children
Type de données
integer
Alias
- UMLS CUI [1]
- C2229974
Description
Fathers Age
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0001779
Description
Fathers Race
Type de données
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0034510
Description
GlaxoSmithKline Drug/Vaccine Information and Concomitant Medications
Alias
- UMLS CUI-1
- C1546482
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C1533716
- UMLS CUI-4
- C2347852
Description
Drug/Vaccine/OTC Name
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0027365
- UMLS CUI [2,1]
- C0042210
- UMLS CUI [2,2]
- C0027365
- UMLS CUI [3,1]
- C0013231
- UMLS CUI [3,2]
- C0027365
Description
Dosing Regimen and Frequency of Dosing
Type de données
text
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0678766
- UMLS CUI [2]
- C2982514
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0808070
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0806020
Description
Check Box if Continuing
Type de données
boolean
Alias
- UMLS CUI [1]
- C1553904
Description
Indication
Type de données
text
Alias
- UMLS CUI [1]
- C3146298
Description
Current pregnancy information/status
Alias
- UMLS CUI-1
- C0552579
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0425932
Description
Last Period Unknown
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C2825543
Description
Pregnancy status
Type de données
integer
Alias
- UMLS CUI [1]
- C0552579
Description
Delivery Method
Type de données
text
Alias
- UMLS CUI [1]
- C0565867
Description
If one of these boxes is checked, please note details in ,,Additional details" below
Type de données
integer
Alias
- UMLS CUI [1]
- C0156543
Description
Other early termination
Type de données
text
Alias
- UMLS CUI [1,1]
- C0156543
- UMLS CUI [1,2]
- C0205394
Description
If "Birth defect" or "Other disorder" is checked please note deatils in "Additional details" below
Type de données
integer
Alias
- UMLS CUI [1]
- C3503749
- UMLS CUI [2]
- C4042838
Description
Multiple births
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2015861
- UMLS CUI [1,2]
- C2229974
Description
(send separate form for each child) Please submit additional information on a separate sheet.
Type de données
integer
Alias
- UMLS CUI [1]
- C0005607
Description
Discharge summary notes
Type de données
text
Alias
- UMLS CUI [1]
- C0242482
Description
Additional details
Type de données
text
Alias
- UMLS CUI [1,1]
- C1546922
- UMLS CUI [1,2]
- C0747843
- UMLS CUI [2,1]
- C1546922
- UMLS CUI [2,2]
- C0022864
- UMLS CUI [3,1]
- C1546922
- UMLS CUI [3,2]
- C0005615
- UMLS CUI [4,1]
- C1546922
- UMLS CUI [4,2]
- C0015965
- UMLS CUI [5,1]
- C1546922
- UMLS CUI [5,2]
- C0021270
Description
Infant information
Alias
- UMLS CUI-1
- C0511470
Description
Gestational weeks at birth/miscarriage/termination
Type de données
integer
Unités de mesure
- weeks
Alias
- UMLS CUI [1,1]
- C0439671
- UMLS CUI [1,2]
- C0439230
- UMLS CUI [1,3]
- C0005615
- UMLS CUI [2,1]
- C0439671
- UMLS CUI [2,2]
- C0439230
- UMLS CUI [2,3]
- C0000786
- UMLS CUI [3,1]
- C0439671
- UMLS CUI [3,2]
- C0439230
- UMLS CUI [3,3]
- C0156543
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005615
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0000786
- UMLS CUI [3,1]
- C0011008
- UMLS CUI [3,2]
- C0156543
Description
Sex
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C2361123
Description
Length of infant
Type de données
float
Alias
- UMLS CUI [1,1]
- C1444754
- UMLS CUI [1,2]
- C0021270
Description
Unit Length
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0439148
- UMLS CUI [1,2]
- C1444754
Description
Weight of infant
Type de données
float
Alias
- UMLS CUI [1]
- C0745274
Description
Unit Weight
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0439148
- UMLS CUI [1,2]
- C0043100
Description
0-10
Type de données
integer
Alias
- UMLS CUI [1]
- C0003533
Description
Apgar Score unknown
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0003533
- UMLS CUI [1,2]
- C0439673
Description
Relevant Laboratory Test and Procedures
Alias
- UMLS CUI-1
- C0022885
Description
(e.g., ultrasound, amniocentesis, chorionic villi sampling, autopsy on products of gestation) In case of an abnormal evolution or outcome, please send a copy of all relevant laboratory tests and procedures and complete the AE or SAE form as appropriate.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C0085415
Description
Drug/Vaccine related problems
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0033213
- UMLS CUI [2,1]
- C0042210
- UMLS CUI [2,2]
- C2347852
- UMLS CUI [2,3]
- C0033213
Description
Reporter's signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
(If not the same as reporter)
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Pregnancy Notification Form
- StudyEvent: ODM
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C1547742 (UMLS CUI [2,1])
C0008961 (UMLS CUI [2,2])
C0008961 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C0026591 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0005615 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
C1709908 (UMLS CUI [1,2])
C1709908 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C0015671 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
C0439673 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
C0034510 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C2347852 (UMLS CUI-4)
C0027365 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0027365 (UMLS CUI [2,2])
C0013231 (UMLS CUI [3,1])
C0027365 (UMLS CUI [3,2])
C0678766 (UMLS CUI [1,2])
C2982514 (UMLS CUI [2])
C0439673 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C4042838 (UMLS CUI [2])
C2229974 (UMLS CUI [1,2])
C0747843 (UMLS CUI [1,2])
C1546922 (UMLS CUI [2,1])
C0022864 (UMLS CUI [2,2])
C1546922 (UMLS CUI [3,1])
C0005615 (UMLS CUI [3,2])
C1546922 (UMLS CUI [4,1])
C0015965 (UMLS CUI [4,2])
C1546922 (UMLS CUI [5,1])
C0021270 (UMLS CUI [5,2])
C0439230 (UMLS CUI [1,2])
C0005615 (UMLS CUI [1,3])
C0439671 (UMLS CUI [2,1])
C0439230 (UMLS CUI [2,2])
C0000786 (UMLS CUI [2,3])
C0439671 (UMLS CUI [3,1])
C0439230 (UMLS CUI [3,2])
C0156543 (UMLS CUI [3,3])
C0005615 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0000786 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3,1])
C0156543 (UMLS CUI [3,2])
C0021270 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C0085415 (UMLS CUI [1,2])
C0033213 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C0033213 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])