ID

25643

Description

Study part: Pregnancy Notification Form. A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. 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. Study ID: 101468/201. Clinical Study ID: 101468/201

Keywords

Versions (2)
  1. 9/8/17 9/8/17 -
  2. 5/10/19 5/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 8, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Pregnancy Notification Form Ropinirole Restless Legs Syndrome 101468/201

English

Pregnancy Notification Form

1 forms  
REPORTER INFORMATION
Description

REPORTER INFORMATION

Alias
UMLS CUI-1
C3840395
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Reporter name:
Description

Reporter

Data type

text

Alias
UMLS CUI [1]
C1709908
Title:
Description

Title

Data type

text

Alias
UMLS CUI [1]
C3888414
Address:
Description

Address

Data type

text

Alias
UMLS CUI [1]
C1442065
Telephone No:
Description

Telephone No

Data type

integer

Alias
UMLS CUI [1]
C1515258
Fax No:
Description

Fax No

Data type

integer

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

City

Data type

text

Alias
UMLS CUI [1]
C2316883
Postal Code:
Description

Postal Code

Data type

integer

Alias
UMLS CUI [1]
C1514254
Country
Description

Country

Data type

text

Alias
UMLS CUI [1]
C1562954
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
Description

MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0026591
Family or Medical History
Description

(i.e. Include alcohol/tobacco and substance abuse, complications of past pregnancy, labor/delivery, fetus/baby, illness during this pregnancy, assisted conception: specify, other disorders including familial birth defects/genetic/chromosomal disorders, methods of diagnosis consanguinity etc)

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0026591
Number of spontaneous abortion:
Description

Number of spontaneous abortion

Data type

integer

Alias
UMLS CUI [1,1]
C0000786
UMLS CUI [1,2]
C0449788
Number of therapeutic abortion:
Description

Number of therapeutic abortion

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C0032961
Number of previous Pregnancies Terminations- Other:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Full term:
Description

Full term birth

Data type

integer

Alias
UMLS CUI [1]
C3814420
Pre term:
Description

Pre term delivery

Data type

integer

Alias
UMLS CUI [1]
C4314862
Stillbirths:
Description

Stillbirths

Data type

integer

Alias
UMLS CUI [1]
C0595939
Deliveries:
Description

Deliveries

Data type

integer

Alias
UMLS CUI [1]
C0011209
Children born with defects:
Description

Children born with defects

Data type

integer

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2229974
Normal Births:
Description

Normal Births

Data type

integer

Alias
UMLS CUI [1,1]
C3665337
UMLS CUI [1,2]
C0449788
Outcome Unknown:
Description

Outcome Unknown

Data type

integer

Alias
UMLS CUI [1]
C0810347
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
Description

FATHER’S RELEVANT MEDICAL/FAMILY HISTORY

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0015671
Information provided by:
Description

Information provided by

Data type

text

Alias
UMLS CUI [1]
C0518629
Other, please specify:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Medical Or 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]
C0262926
UMLS CUI [1,2]
C0015671
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
Age:
Description

Age

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1]
C0001779
years
Race:
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
Description

GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
Reported Drug/ Vaccine/OTC name (generic or trade name)
Description

Concomitant Medication

Data type

text

Alias
UMLS CUI [1]
C2347852
Dosing Regimen & Frequency of Dosing
Description

Regimen Dosing

Data type

text

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C0178602
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Continuing
Description

continuing therapy Concomitant Medication

Data type

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2347852
Indication
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
CURRENT PREGNANCY INFORMATION
Description

CURRENT PREGNANCY INFORMATION

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Date of last menstrual period
Description

Date of last menstrual period

Data type

date

Alias
UMLS CUI [1]
C0425932
Unknown
Description

Unknown

Data type

boolean

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

Estimated date of delivery

Data type

date

Alias
UMLS CUI [1]
C1287845
PREGNANCY STATUS
Description

PREGNANCY STATUS

Alias
UMLS CUI-1
C0552579
Pregnancy Ongoing
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0549206
Delivery Method:
Description

Delivery Method

Data type

text

Alias
UMLS CUI [1]
C0565867
Stillbirth
Description

Stillbirth

Data type

boolean

Alias
UMLS CUI [1]
C0595939
Fetal death
Description

Fetal death

Data type

boolean

Alias
UMLS CUI [1]
C0015927
Early Termination
Description

Early Termination

Data type

text

Alias
UMLS CUI [1]
C0156543
FETAL/ NEONATAL STATUS
Description

FETAL/ NEONATAL STATUS

Alias
UMLS CUI-1
C3533197
Fetal/Neonatal Status
Description

Neonatal status

Data type

integer

Alias
UMLS CUI [1]
C3533197
INFANT INFORMATION
Description

INFANT INFORMATION

Alias
UMLS CUI-1
C3840300
Gestational weeks at birth/miscarriage/ termination:
Description

Gestational weeks

Data type

integer

Measurement units
  • Weeks
Alias
UMLS CUI [1]
C1954788
Weeks
Date of birth/miscarriage/termination:
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C2348576
Sex:
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Date of discharge:
Description

Date of discharge

Data type

date

Alias
UMLS CUI [1]
C2361123
Length in cm
Description

Length

Data type

float

Alias
UMLS CUI [1]
C0221097
Length in inches
Description

Length

Data type

float

Alias
UMLS CUI [1]
C0221097
Weight in kg
Description

Weight

Data type

float

Alias
UMLS CUI [1]
C0005910
Weight in lb
Description

Weight

Data type

float

Alias
UMLS CUI [1]
C0005910
Apgar score (0-10):
Description

Apgar score

Data type

integer

Alias
UMLS CUI [1]
C0003533
If multiple births (e.g., twins), indicate number:
Description

multiple births

Data type

integer

Alias
UMLS CUI [1]
C2015861
Birth order (1,2,3,etc)
Description

Birth order

Data type

integer

Alias
UMLS CUI [1]
C0005607
Discharge summary notes:
Description

Discharge summary notes

Data type

text

Alias
UMLS CUI [1]
C1317307
Additional details on current pregnancy, labor/delivery, fetus and/or infant:
Description

Additional details

Data type

text

Alias
UMLS CUI [1]
C1546922
RELEVANT LABORATORY TESTS & PROCEDURES
Description

RELEVANT LABORATORY TESTS & PROCEDURES

Alias
UMLS CUI-1
C0022885
RELEVANT LABORATORY TESTS & PROCEDURES (e.g., ultrasound, amniocentesis, chorionic villi sampling, autopsy on products of gestation)
Description

LABORATORY TESTS

Data type

text

Alias
UMLS CUI [1]
C0022885
If any problems occurred, do you believe they may be drug ( or vaccine) related?
Description

Causations

Data type

boolean

Alias
UMLS CUI [1]
C0085978
Investigator Name:
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Pregnancy Notification Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
REPORTER INFORMATION
C3840395 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Reporter
Item
Reporter name:
text
C1709908 (UMLS CUI [1])
Title
Item
Title:
text
C3888414 (UMLS CUI [1])
Address
Item
Address:
text
C1442065 (UMLS CUI [1])
Telephone No
Item
Telephone No:
integer
C1515258 (UMLS CUI [1])
Fax No
Item
Fax No:
integer
C1549619 (UMLS CUI [1])
City
Item
City, State/Province:
text
C2316883 (UMLS CUI [1])
Postal Code
Item
Postal Code:
integer
C1514254 (UMLS CUI [1])
Country
Item
Country
text
C1562954 (UMLS CUI [1])
Item Group
MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
C0262926 (UMLS CUI-1)
C0026591 (UMLS CUI-2)
medical history mother
Item
Family or Medical History
text
C0262926 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
Number of spontaneous abortion
Item
Number of spontaneous abortion:
integer
C0000786 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of therapeutic abortion
Item
Number of therapeutic abortion:
integer
C0030705 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Other
Item
Number of previous Pregnancies Terminations- Other:
text
C0205394 (UMLS CUI [1])
Full term birth
Item
Full term:
integer
C3814420 (UMLS CUI [1])
Pre term delivery
Item
Pre term:
integer
C4314862 (UMLS CUI [1])
Stillbirths
Item
Stillbirths:
integer
C0595939 (UMLS CUI [1])
Deliveries
Item
Deliveries:
integer
C0011209 (UMLS CUI [1])
Children born with defects
Item
Children born with defects:
integer
C0000768 (UMLS CUI [1,1])
C2229974 (UMLS CUI [1,2])
Normal Births
Item
Normal Births:
integer
C3665337 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Outcome Unknown
Item
Outcome Unknown:
integer
C0810347 (UMLS CUI [1])
Item Group
FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
C0262926 (UMLS CUI-1)
C0015671 (UMLS CUI-2)
Item
Information provided by:
text
C0518629 (UMLS CUI [1])
Information provided by
Code List
Information provided by:
CL Item
Father (Father)
CL Item
Other (Other)
Other
Item
Other, please specify:
text
C0205394 (UMLS CUI [1])
medical history father
Item
Medical Or Family History
text
C0262926 (UMLS CUI [1,1])
C0015671 (UMLS CUI [1,2])
Father Unknown
Item
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])
Age
Item
Age:
integer
C0001779 (UMLS CUI [1])
Race
Item
Race:
text
C0034510 (UMLS CUI [1])
Item Group
GLAXOSMITHKLINE DRUG/VACCINE INFORMATION AND CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Reported Drug/ Vaccine/OTC name (generic or trade name)
text
C2347852 (UMLS CUI [1])
Regimen Dosing
Item
Dosing Regimen & Frequency of Dosing
text
C1276413 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
continuing therapy Concomitant Medication
Item
Continuing
boolean
C1553904 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Item Group
CURRENT PREGNANCY INFORMATION
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Date of last menstrual period
Item
Date of last menstrual period
date
C0425932 (UMLS CUI [1])
Unknown
Item
Unknown
boolean
C0439673 (UMLS CUI [1])
Estimated date of delivery
Item
Estimated date of delivery
date
C1287845 (UMLS CUI [1])
Item Group
PREGNANCY STATUS
C0552579 (UMLS CUI-1)
Pregnancy
Item
Pregnancy Ongoing
boolean
C0549206 (UMLS CUI [1])
Delivery Method
Item
Delivery Method:
text
C0565867 (UMLS CUI [1])
Stillbirth
Item
Stillbirth
boolean
C0595939 (UMLS CUI [1])
Fetal death
Item
Fetal death
boolean
C0015927 (UMLS CUI [1])
Item
Early Termination
text
C0156543 (UMLS CUI [1])
Early Termination
Code List
Early Termination
CL Item
Spontaneous abortion (Spontaneous abortion)
C0000786 (UMLS CUI-1)
(Comment:en)
CL Item
Therapeutic abortion (Therapeutic abortion)
C3146284 (UMLS CUI-1)
(Comment:en)
CL Item
Other (Other)
C0205394 (UMLS CUI-1)
(Comment:en)
Item Group
FETAL/ NEONATAL STATUS
C3533197 (UMLS CUI-1)
Item
Fetal/Neonatal Status
integer
C3533197 (UMLS CUI [1])
Neonatal status
Code List
Fetal/Neonatal Status
CL Item
Normal  (1)
CL Item
Birth defect (structural/chromosomal disorder) (2)
CL Item
Other disorder (non-structural, premature birth,intrauterine death/stillbirth) (3)
Item Group
INFANT INFORMATION
C3840300 (UMLS CUI-1)
Gestational weeks
Item
Gestational weeks at birth/miscarriage/ termination:
integer
C1954788 (UMLS CUI [1])
Date of birth
Item
Date of birth/miscarriage/termination:
date
C2348576 (UMLS CUI [1])
Item
Sex:
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex:
CL Item
Male (Male)
CL Item
Female (Female)
CL Item
Unknown (Unknown)
Date of discharge
Item
Date of discharge:
date
C2361123 (UMLS CUI [1])
Length
Item
Length in cm
float
C0221097 (UMLS CUI [1])
Length
Item
Length in inches
float
C0221097 (UMLS CUI [1])
Weight
Item
Weight in kg
float
C0005910 (UMLS CUI [1])
Weight
Item
Weight in lb
float
C0005910 (UMLS CUI [1])
Apgar score
Item
Apgar score (0-10):
integer
C0003533 (UMLS CUI [1])
multiple births
Item
If multiple births (e.g., twins), indicate number:
integer
C2015861 (UMLS CUI [1])
Birth order
Item
Birth order (1,2,3,etc)
integer
C0005607 (UMLS CUI [1])
Discharge summary notes
Item
Discharge summary notes:
text
C1317307 (UMLS CUI [1])
Additional details
Item
Additional details on current pregnancy, labor/delivery, fetus and/or infant:
text
C1546922 (UMLS CUI [1])
Item Group
RELEVANT LABORATORY TESTS & PROCEDURES
C0022885 (UMLS CUI-1)
LABORATORY TESTS
Item
RELEVANT LABORATORY TESTS & PROCEDURES (e.g., ultrasound, amniocentesis, chorionic villi sampling, autopsy on products of gestation)
text
C0022885 (UMLS CUI [1])
Causations
Item
If any problems occurred, do you believe they may be drug ( or vaccine) related?
boolean
C0085978 (UMLS CUI [1])
Investigator Name
Item
Investigator Name:
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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