ID
36125
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 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.
Trefwoorden
Versies (2)
- 15-04-19 15-04-19 -
- 16-04-19 16-04-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 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
Pregnancy Notification Form
- StudyEvent: ODM
Beschrijving
Reporter Information
Alias
- UMLS CUI-1
- C3840395
Beschrijving
Reporter name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigators Title
Datatype
text
Alias
- UMLS CUI [1,1]
- C3888414
- UMLS CUI [1,2]
- C0008961
Beschrijving
Investigators Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0008961
Beschrijving
Telephone No.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1515258
- UMLS CUI [1,2]
- C0008961
Beschrijving
Fax No.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1549619
- UMLS CUI [1,2]
- C0008961
Beschrijving
City, State/Province
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008848
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [2,1]
- C1547742
- UMLS CUI [2,2]
- C0008961
Beschrijving
Postal Code
Datatype
text
Alias
- UMLS CUI [1,1]
- C1514254
- UMLS CUI [1,2]
- C0008961
Beschrijving
Country
Datatype
text
Alias
- UMLS CUI [1,1]
- C0454664
- UMLS CUI [1,2]
- C0008961
Beschrijving
Mother's relevant medical/family history
Alias
- UMLS CUI-1
- C0026591
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0241889
Beschrijving
(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.)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0026591
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0026591
- UMLS CUI [2,2]
- C0241889
Beschrijving
Number of previous Pregnancies
Datatype
integer
Alias
- UMLS CUI [1]
- C3814420
Beschrijving
Number of previous Pregnancies
Datatype
integer
Alias
- UMLS CUI [1]
- C0151526
Beschrijving
Birth Termination
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1283212
- UMLS CUI [1,2]
- C0005615
Beschrijving
Father's relevant medical/family history
Alias
- UMLS CUI-1
- C0015671
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0241889
Beschrijving
Information provided
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1533716
- UMLS CUI [1,2]
- C1709908
Beschrijving
Information reported, other
Datatype
text
Alias
- UMLS CUI [1,1]
- C1533716
- UMLS CUI [1,2]
- C1709908
- UMLS CUI [1,3]
- C0205394
Beschrijving
(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)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0015671
- UMLS CUI [2,2]
- C0241889
Beschrijving
Father Unknown
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0439673
Beschrijving
Number of children
Datatype
integer
Alias
- UMLS CUI [1]
- C2229974
Beschrijving
Fathers Age
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0001779
Beschrijving
Fathers Race
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015671
- UMLS CUI [1,2]
- C0034510
Beschrijving
GlaxoSmithKline Drug/Vaccine Information and Concomitant Medications
Alias
- UMLS CUI-1
- C1546482
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C1533716
- UMLS CUI-4
- C2347852
Beschrijving
Drug/Vaccine/OTC Name
Datatype
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
Beschrijving
Dosing Regimen and Frequency of Dosing
Datatype
text
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0678766
- UMLS CUI [2]
- C2982514
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Check Box if Continuing
Datatype
boolean
Alias
- UMLS CUI [1]
- C1553904
Beschrijving
Indication
Datatype
text
Alias
- UMLS CUI [1]
- C3146298
Beschrijving
Current pregnancy information/status
Alias
- UMLS CUI-1
- C0552579
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0425932
Beschrijving
Last Period Unknown
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2825543
Beschrijving
Pregnancy status
Datatype
integer
Alias
- UMLS CUI [1]
- C0552579
Beschrijving
Delivery Method
Datatype
text
Alias
- UMLS CUI [1]
- C0565867
Beschrijving
If one of these boxes is checked, please note details in ,,Additional details" below
Datatype
integer
Alias
- UMLS CUI [1]
- C0156543
Beschrijving
Other early termination
Datatype
text
Alias
- UMLS CUI [1,1]
- C0156543
- UMLS CUI [1,2]
- C0205394
Beschrijving
If "Birth defect" or "Other disorder" is checked please note deatils in "Additional details" below
Datatype
integer
Alias
- UMLS CUI [1]
- C3503749
- UMLS CUI [2]
- C4042838
Beschrijving
Multiple births
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2015861
- UMLS CUI [1,2]
- C2229974
Beschrijving
(send separate form for each child) Please submit additional information on a separate sheet.
Datatype
integer
Alias
- UMLS CUI [1]
- C0005607
Beschrijving
Discharge summary notes
Datatype
text
Alias
- UMLS CUI [1]
- C0242482
Beschrijving
Additional details
Datatype
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
Beschrijving
Infant information
Alias
- UMLS CUI-1
- C0511470
Beschrijving
Gestational weeks at birth/miscarriage/termination
Datatype
integer
Maateenheden
- 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
Beschrijving
day month year
Datatype
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
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2361123
Beschrijving
Length of infant
Datatype
float
Alias
- UMLS CUI [1,1]
- C1444754
- UMLS CUI [1,2]
- C0021270
Beschrijving
Unit Length
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439148
- UMLS CUI [1,2]
- C1444754
Beschrijving
Weight of infant
Datatype
float
Alias
- UMLS CUI [1]
- C0745274
Beschrijving
Unit Weight
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439148
- UMLS CUI [1,2]
- C0043100
Beschrijving
0-10
Datatype
integer
Alias
- UMLS CUI [1]
- C0003533
Beschrijving
Apgar Score unknown
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0003533
- UMLS CUI [1,2]
- C0439673
Beschrijving
Relevant Laboratory Test and Procedures
Alias
- UMLS CUI-1
- C0022885
Beschrijving
(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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C0085415
Beschrijving
Drug/Vaccine related problems
Datatype
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
Beschrijving
Reporter's signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
(If not the same as reporter)
Datatype
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])