ID
36116
Beskrivning
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.
Nyckelord
Versioner (2)
- 2019-04-15 2019-04-15 -
- 2019-04-16 2019-04-16 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 april 2019
DOI
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Licens
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
Beskrivning
GlaxoSmithKline Drug/Vaccine Information and Concomitant Medications
Alias
- UMLS CUI-1
- C1546482
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C1533716
- UMLS CUI-4
- C2347852
Beskrivning
Drug/Vaccine/OTC Name
Datatyp
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
Beskrivning
Dosing Regimen and Frequency of Dosing
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0678766
- UMLS CUI [2]
- C2982514
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Check Box if Continuing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1553904
Beskrivning
Indication
Datatyp
text
Alias
- UMLS CUI [1]
- C3146298
Beskrivning
Relevant Laboratory Test and Procedures
Alias
- UMLS CUI-1
- C0022885
Beskrivning
(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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1707478
Beskrivning
Abnormal evolution/outcome
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0033213
- UMLS CUI [1,2]
- C1709683
Beskrivning
Reporter's signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
(If not the same as reporter)
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Current pregnancy information/status
Alias
- UMLS CUI-1
- C0552579
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C0425932
Beskrivning
Last Period Unknown
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2825543
Beskrivning
Pregnancy status
Datatyp
integer
Alias
- UMLS CUI [1]
- C0552579
Beskrivning
Delivery Method
Datatyp
text
Alias
- UMLS CUI [1]
- C0565867
Beskrivning
If one of these boxes is checked, please note details in ,,Additional details" below
Datatyp
integer
Alias
- UMLS CUI [1]
- C0156543
Beskrivning
Other early termination
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0156543
- UMLS CUI [1,2]
- C0205394
Beskrivning
If "Birth defect" or "Other disorder" is checked please note deatils in "Additional details" below
Datatyp
integer
Alias
- UMLS CUI [1]
- C3503749
- UMLS CUI [2]
- C4042838
Beskrivning
Multiple births
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2015861
- UMLS CUI [1,2]
- C2229974
Beskrivning
(send separate form for each child) Please submit additional information on a separate sheet.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005607
Beskrivning
Discharge summary notes
Datatyp
text
Alias
- UMLS CUI [1]
- C0242482
Beskrivning
Additional details
Datatyp
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
Beskrivning
Infant information
Alias
- UMLS CUI-1
- C0511470
Beskrivning
Gestational weeks at birth/miscarriage/termination
Datatyp
integer
Måttenheter
- 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
Beskrivning
day month year
Datatyp
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
Beskrivning
Sex
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2361123
Beskrivning
Length of infant
Datatyp
float
Alias
- UMLS CUI [1,1]
- C1444754
- UMLS CUI [1,2]
- C0021270
Beskrivning
Unit Length
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439148
- UMLS CUI [1,2]
- C1444754
Beskrivning
Weight of infant
Datatyp
float
Alias
- UMLS CUI [1]
- C0745274
Beskrivning
Unit Weight
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439148
- UMLS CUI [1,2]
- C0043100
Beskrivning
0-10
Datatyp
integer
Alias
- UMLS CUI [1]
- C0003533
Beskrivning
Apgar Score unknown
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0003533
- UMLS CUI [1,2]
- C0439673
Beskrivning
Reporter Information
Alias
- UMLS CUI-1
- C3840395
Beskrivning
Reporter name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Investigators Title
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3888414
- UMLS CUI [1,2]
- C0008961
Beskrivning
Investigators Address
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beskrivning
Telephone No.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0008961
Beskrivning
Fax No.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1549619
- UMLS CUI [1,2]
- C0008961
Beskrivning
City, State/Province
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008848
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [2,1]
- C1547742
- UMLS CUI [2,2]
- C0008961
Beskrivning
Postal Code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1514254
- UMLS CUI [1,2]
- C0008961
Beskrivning
Country
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0454664
- UMLS CUI [1,2]
- C0008961
Beskrivning
Mother's relevant medical/family history
Alias
- UMLS CUI-1
- C0026591
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0241889
Beskrivning
(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.)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0026591
- UMLS CUI [2,2]
- C0241889
Beskrivning
Number of previous Pregnancies
Datatyp
integer
Alias
- UMLS CUI [1]
- C3814420
Beskrivning
Number of previous Pregnancies
Datatyp
integer
Alias
- UMLS CUI [1]
- C0151526
Beskrivning
Birth Termination
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1283212
- UMLS CUI [1,2]
- C0005615
Beskrivning
Father's relevant medical/family history
Alias
- UMLS CUI-1
- C0015671
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0241889
Beskrivning
Information provided
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1533716
- UMLS CUI [1,2]
- C1709908
Beskrivning
Information reported, other
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1533716
- UMLS CUI [1,2]
- C1709908
- UMLS CUI [1,3]
- C0205394
Beskrivning
(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)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0015671
- UMLS CUI [2,2]
- C0241889
Beskrivning
Father Unknown
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Beskrivning
Number of children
Datatyp
integer
Alias
- UMLS CUI [1]
- C2229974
Beskrivning
Fathers Age
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0001779
Beskrivning
Fathers Race
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0034510
Similar models
Pregnancy Notification Form
- StudyEvent: ODM
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])
C1707478 (UMLS CUI [1,2])
C1709683 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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])
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])