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.

Keywords

Versions (2)
  1. 4/15/19 4/15/19 -
  2. 4/16/19 4/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 16, 2019

DOI

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License

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

English

Pregnancy Notification Form

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
GSK Receipt Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Reporter Information
Description

Reporter Information

Alias
UMLS CUI-1
C3840395
Reporter name
Description

Reporter name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigators Title
Description

Investigators Title

Data type

text

Alias
UMLS CUI [1,1]
C3888414
UMLS CUI [1,2]
C0008961
Investigators Address
Description

Investigators Address

Data type

text

Alias
UMLS CUI [1,1]
C1442065
UMLS CUI [1,2]
C0008961
Telephone No.
Description

Telephone No.

Data type

integer

Alias
UMLS CUI [1,1]
C1515258
UMLS CUI [1,2]
C0008961
Fax No.
Description

Fax No.

Data type

integer

Alias
UMLS CUI [1,1]
C1549619
UMLS CUI [1,2]
C0008961
City, State/Province
Description

City, State/Province

Data type

text

Alias
UMLS CUI [1,1]
C0008848
UMLS CUI [1,2]
C0008961
UMLS CUI [2,1]
C1547742
UMLS CUI [2,2]
C0008961
Postal Code
Description

Postal Code

Data type

text

Alias
UMLS CUI [1,1]
C1514254
UMLS CUI [1,2]
C0008961
Country
Description

Country

Data type

text

Alias
UMLS CUI [1,1]
C0454664
UMLS CUI [1,2]
C0008961
Mother's relevant medical/family history
Description

Mother's relevant medical/family history

Alias
UMLS CUI-1
C0026591
UMLS CUI-2
C0262926
UMLS CUI-3
C0241889
Mother's relevant medical/family history
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.)

Data type

text

Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0026591
UMLS CUI [2,2]
C0241889
Full term pregnancies
Description

Number of previous Pregnancies

Data type

integer

Alias
UMLS CUI [1]
C3814420
Pre term pregnancies
Description

Number of previous Pregnancies

Data type

integer

Alias
UMLS CUI [1]
C0151526
Birth Termination
Description

Birth Termination

Data type

integer

Alias
UMLS CUI [1,1]
C1283212
UMLS CUI [1,2]
C0005615
Father's relevant medical/family history
Description

Father's relevant medical/family history

Alias
UMLS CUI-1
C0015671
UMLS CUI-2
C0262926
UMLS CUI-3
C0241889
Information provided
Description

Information provided

Data type

integer

Alias
UMLS CUI [1,1]
C1533716
UMLS CUI [1,2]
C1709908
If other, please specify
Description

Information reported, other

Data type

text

Alias
UMLS CUI [1,1]
C1533716
UMLS CUI [1,2]
C1709908
UMLS CUI [1,3]
C0205394
Father's relevant medical/family history
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)

Data type

text

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0015671
UMLS CUI [2,2]
C0241889
Tick if Father Unknown
Description

Father Unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0439673
Number of children
Description

Number of children

Data type

integer

Alias
UMLS CUI [1]
C2229974
Fathers Age
Description

Fathers Age

Data type

integer

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0001779
Fathers Race
Description

Fathers Race

Data type

text

Alias
UMLS CUI [1,1]
C0015671
UMLS CUI [1,2]
C0034510
GlaxoSmithKline Drug/Vaccine Information and Concomitant Medications
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
Reported Drug / Vaccine / OTC Name (generic or trade name)
Description

Drug/Vaccine/OTC Name

Data type

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
Dosing Regimen and Frequency of Dosing
Description

Dosing Regimen and Frequency of Dosing

Data type

text

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C0678766
UMLS CUI [2]
C2982514
Start Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0808070
End Date or Check Box if Continuing
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0806020
Check Box if Continuing
Description

Check Box if Continuing

Data type

boolean

Alias
UMLS CUI [1]
C1553904
Indication
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Current pregnancy information/status
Description

Current pregnancy information/status

Alias
UMLS CUI-1
C0552579
Date of last menstrual period or check box if last period unknown
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0425932
Last Period Unknown
Description

Last Period Unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0425932
UMLS CUI [1,2]
C0439673
Estimated date of delivery
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2825543
Pregnancy status
Description

Pregnancy status

Data type

integer

Alias
UMLS CUI [1]
C0552579
If Delivery Method, please specify
Description

Delivery Method

Data type

text

Alias
UMLS CUI [1]
C0565867
If Early Termination, please specify
Description

If one of these boxes is checked, please note details in ,,Additional details" below

Data type

integer

Alias
UMLS CUI [1]
C0156543
If other early termination, please specify
Description

Other early termination

Data type

text

Alias
UMLS CUI [1,1]
C0156543
UMLS CUI [1,2]
C0205394
Fetal/Neonatal Status
Description

If "Birth defect" or "Other disorder" is checked please note deatils in "Additional details" below

Data type

integer

Alias
UMLS CUI [1]
C3503749
UMLS CUI [2]
C4042838
If multiple births (e.g., twins), indicate number
Description

Multiple births

Data type

integer

Alias
UMLS CUI [1,1]
C2015861
UMLS CUI [1,2]
C2229974
Birth Order
Description

(send separate form for each child) Please submit additional information on a separate sheet.

Data type

integer

Alias
UMLS CUI [1]
C0005607
Discharge summary notes
Description

Discharge summary notes

Data type

text

Alias
UMLS CUI [1]
C0242482
Additional details on current pregnancy, labor/delivery, fetus and/or infant
Description

Additional details

Data type

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
Infant information
Description

Infant information

Alias
UMLS CUI-1
C0511470
Gestational weeks at birth/miscarriage/termination
Description

Gestational weeks at birth/miscarriage/termination

Data type

integer

Measurement units
  • 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
weeks
Date of birth/miscarriage/termination
Description

day month year

Data type

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
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Date of Discharge
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2361123
Length of infant
Description

Length of infant

Data type

float

Alias
UMLS CUI [1,1]
C1444754
UMLS CUI [1,2]
C0021270
Unit Length
Description

Unit Length

Data type

integer

Alias
UMLS CUI [1,1]
C0439148
UMLS CUI [1,2]
C1444754
Weight of infant
Description

Weight of infant

Data type

float

Alias
UMLS CUI [1]
C0745274
Unit Weight
Description

Unit Weight

Data type

integer

Alias
UMLS CUI [1,1]
C0439148
UMLS CUI [1,2]
C0043100
Apgar score or check box if unknown
Description

0-10

Data type

integer

Alias
UMLS CUI [1]
C0003533
Apgar Score unknown
Description

Apgar Score unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0003533
UMLS CUI [1,2]
C0439673
Relevant Laboratory Test and Procedures
Description

Relevant Laboratory Test and Procedures

Alias
UMLS CUI-1
C0022885
Abnormal evolution/outcome
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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C0085415
If any problems occurred, do you believe they may be drug (or vaccine) related?
Description

Drug/Vaccine related problems

Data type

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
Reporter's signature
Description

Reporter's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator Name
Description

(If not the same as reporter)

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Pregnancy Notification Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Date
Item
GSK Receipt Date
date
C0011008 (UMLS CUI [1])
Item Group
Reporter Information
C3840395 (UMLS CUI-1)
Reporter name
Item
Reporter name
text
C2826892 (UMLS CUI [1])
Investigators Title
Item
Investigators Title
text
C3888414 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Investigators Address
Item
Investigators Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Telephone No.
Item
Telephone No.
integer
C1515258 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Fax No.
Item
Fax No.
integer
C1549619 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
City, State/Province
Item
City, State/Province
text
C0008848 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C1547742 (UMLS CUI [2,1])
C0008961 (UMLS CUI [2,2])
Postal Code
Item
Postal Code
text
C1514254 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Item Group
Mother's relevant medical/family history
C0026591 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
Mother's relevant medical/family history
Item
Mother's relevant medical/family history
text
C0026591 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0026591 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
Full term pregnancies
Item
Full term pregnancies
integer
C3814420 (UMLS CUI [1])
Pre term pregnancies
Item
Pre term pregnancies
integer
C0151526 (UMLS CUI [1])
Item
Birth Termination
integer
C1283212 (UMLS CUI [1,1])
C0005615 (UMLS CUI [1,2])
Birth Termination
Code List
Birth Termination
CL Item
Spontaneous abortion (1)
CL Item
Therapeutics abortion (2)
CL Item
Stillbirths (3)
CL Item
Deliveries (4)
CL Item
Children born with defects (5)
CL Item
Normal Births (6)
CL Item
Outcome unknown (7)
CL Item
Other (8)
Item Group
Father's relevant medical/family history
C0015671 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0241889 (UMLS CUI-3)
Item
Information provided
integer
C1533716 (UMLS CUI [1,1])
C1709908 (UMLS CUI [1,2])
Information provided
Code List
Information provided
CL Item
Father (1)
CL Item
Other (2)
Information reported, other
Item
If other, please specify
text
C1533716 (UMLS CUI [1,1])
C1709908 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Father's relevant medical/family history
Item
Father's relevant medical/family history
text
C0015671 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0015671 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
Father Unknown
Item
Tick if Father Unknown
boolean
C0015671 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Number of children
Item
Number of children
integer
C2229974 (UMLS CUI [1])
Fathers Age
Item
Fathers Age
integer
C0015671 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Fathers Race
Item
Fathers Race
text
C0015671 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
Item Group
GlaxoSmithKline Drug/Vaccine Information and Concomitant Medications
C1546482 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C2347852 (UMLS CUI-4)
Drug/Vaccine/OTC Name
Item
Reported Drug / Vaccine / OTC Name (generic or trade name)
text
C0013227 (UMLS CUI [1,1])
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])
Dosing Regimen and Frequency of Dosing
Item
Dosing Regimen and Frequency of Dosing
text
C0040808 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C2982514 (UMLS CUI [2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date or Check Box if Continuing
date
C0806020 (UMLS CUI [1])
Check Box if Continuing
Item
Check Box if Continuing
boolean
C1553904 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Item Group
Current pregnancy information/status
C0552579 (UMLS CUI-1)
Date of last menstrual period
Item
Date of last menstrual period or check box if last period unknown
date
C0425932 (UMLS CUI [1])
Last Period Unknown
Item
Last Period Unknown
boolean
C0425932 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Estimated date of delivery
Item
Estimated date of delivery
date
C2825543 (UMLS CUI [1])
Item
Pregnancy status
integer
C0552579 (UMLS CUI [1])
Pregnancy status
Code List
Pregnancy status
CL Item
Pregnancy Ongoing (1)
CL Item
Stillbirth (2)
CL Item
Delivery Method (3)
CL Item
Fetal Death (4)
CL Item
Early Termination (5)
Delivery Method
Item
If Delivery Method, please specify
text
C0565867 (UMLS CUI [1])
Item
If Early Termination, please specify
integer
C0156543 (UMLS CUI [1])
Early Termination, specification
Code List
If Early Termination, please specify
CL Item
Spontaneous abortion (1)
CL Item
Therapeutic abortion (2)
CL Item
Other (3)
Other early termination
Item
If other early termination, please specify
text
C0156543 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Fetal/Neonatal Status
integer
C3503749 (UMLS CUI [1])
C4042838 (UMLS CUI [2])
Fetal/Neonatal Status
Code List
Fetal/Neonatal Status
CL Item
Normal (1)
CL Item
Birth defect (structural/chromosomal disorder) (2)
CL Item
Other disorder (non-structmal, premature birth, intrauterine death/stillbirth) (3)
Multiple births
Item
If multiple births (e.g., twins), indicate number
integer
C2015861 (UMLS CUI [1,1])
C2229974 (UMLS CUI [1,2])
Birth Order
Item
Birth Order
integer
C0005607 (UMLS CUI [1])
Discharge summary notes
Item
Discharge summary notes
text
C0242482 (UMLS CUI [1])
Additional details
Item
Additional details on current pregnancy, labor/delivery, fetus and/or infant
text
C1546922 (UMLS CUI [1,1])
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])
Item Group
Infant information
C0511470 (UMLS CUI-1)
Gestational weeks at birth/miscarriage/termination
Item
Gestational weeks at birth/miscarriage/termination
integer
C0439671 (UMLS CUI [1,1])
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])
Date of birth/miscarriage/termination
Item
Date of birth/miscarriage/termination
date
C0011008 (UMLS CUI [1,1])
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])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
CL Item
Unknown (UK)
Date of Discharge
Item
Date of Discharge
date
C2361123 (UMLS CUI [1])
Length of infant
Item
Length of infant
float
C1444754 (UMLS CUI [1,1])
C0021270 (UMLS CUI [1,2])
Item
Unit Length
integer
C0439148 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
Unit Length
Code List
Unit Length
CL Item
cm (1)
CL Item
in (2)
Weight of infant
Item
Weight of infant
float
C0745274 (UMLS CUI [1])
Item
Unit Weight
integer
C0439148 (UMLS CUI [1,1])
C0043100 (UMLS CUI [1,2])
Unit Weight
Code List
Unit Weight
CL Item
g (1)
CL Item
lbs/oz (2)
Apgar score
Item
Apgar score or check box if unknown
integer
C0003533 (UMLS CUI [1])
Apgar Score unknown
Item
Apgar Score unknown
boolean
C0003533 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Item Group
Relevant Laboratory Test and Procedures
C0022885 (UMLS CUI-1)
Abnormal evolution/outcome
Item
Abnormal evolution/outcome
boolean
C0205161 (UMLS CUI [1,1])
C0085415 (UMLS CUI [1,2])
Item
If any problems occurred, do you believe they may be drug (or vaccine) related?
text
C0013227 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C0033213 (UMLS CUI [2,3])
Abnormal evolution/outcome
Code List
If any problems occurred, do you believe they may be drug (or vaccine) related?
CL Item
No (N)
CL Item
Yes (Y)
Reporter's signature
Item
Reporter's signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
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