ID

34512

Beschrijving

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form should be completed according to the protocol reporting requirements. Complete this 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 or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject’s Case Report Form. Note: This form does not routinely need to be completed for subject’s partner pregnancy unless there is specific instruction to do so stated in the protocol.

Trefwoorden

Versies (2)
  1. 14-01-19 14-01-19 -
  2. 18-01-19 18-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

18 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

Engels

Pregnancy Notification Form

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschrijving

Centre Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Randomisation Number
Beschrijving

Randomisation Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Subject Identification
Beschrijving

Subject Identification

Datatype

text

Alias
UMLS CUI [1]
C1269815
Mother's relevant medical/family history
Beschrijving

Mother's relevant medical/family history

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0241889
UMLS CUI-3
C0026591
Mother's date of birth
Beschrijving

Mother's date of birth

Datatype

date

Maateenheden
  • Day Month Year
Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0421451
Day Month Year
Date of last menstrual period
Beschrijving

Date of last menstrual period

Datatype

date

Maateenheden
  • Day Month Year
Alias
UMLS CUI [1]
C0425932
Day Month Year
Estimated date of delivery
Beschrijving

Estimated date of delivery

Datatype

date

Maateenheden
  • Day Month Year
Alias
UMLS CUI [1]
C1287845
Day Month Year
Was the mother using a method of contraception?
Beschrijving

Was the mother using a method of contraception?

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
If Yes, specify:
Beschrijving

If Yes, specify:

Datatype

text

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C2348235
Type of conception, tick one:
Beschrijving

Type of conception, tick one:

Datatype

text

Alias
UMLS CUI [1]
C2598844
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Beschrijving

Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0430022
UMLS CUI [2]
C1456803
UMLS CUI [3]
C0002627
UMLS CUI [4]
C0002627
UMLS CUI [5]
C0008509
UMLS CUI [6,1]
C0332257
UMLS CUI [6,2]
C2985720
Number of previous pregnancies: Pre-term
Beschrijving

If applicable, record the number in the appropriate categories below

Datatype

integer

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1547235
UMLS CUI [1,3]
C0449788
Number of previous pragnancies: Full-term
Beschrijving

If applicable, record the number in the appropriate categories below

Datatype

integer

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C3814420
UMLS CUI [1,3]
C0449788
Normal births
Beschrijving

Normal births

Datatype

integer

Alias
UMLS CUI [1]
C3665337
Stillbirths
Beschrijving

Stillbirths

Datatype

integer

Alias
UMLS CUI [1]
C0595939
Children born with defects
Beschrijving

Children born with defects

Datatype

integer

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C2229974
Record details of children born with defects
Beschrijving

Record details of children born with defects

Datatype

text

Alias
UMLS CUI [1,1]
C1522508
UMLS CUI [1,2]
C0000768
UMLS CUI [1,3]
C2229974
Spontaneous abortion
Beschrijving

Spontaneous abortion

Datatype

integer

Alias
UMLS CUI [1]
C0000786
Elective abortion
Beschrijving

Elective abortion

Datatype

integer

Alias
UMLS CUI [1]
C0269439
Other
Beschrijving

Other

Datatype

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0156543
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Beschrijving

Are there any additional factors that may have an impact on the outcome of this pregnancy?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032972
UMLS CUI [1,2]
C1521761
If Yes, specify
Beschrijving

If Yes, specify

Datatype

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0032972
UMLS CUI [1,3]
C1521761
Father's Relevant Medical/Family History
Beschrijving

Father's Relevant Medical/Family History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0241889
UMLS CUI-3
C0015671
Father's Relevant Medical/Family History
Beschrijving

Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/ chromosomal disorders and medication use

Datatype

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0241889
UMLS CUI [1,3]
C0015671
Drug Exposures
Beschrijving

Drug Exposures

Alias
UMLS CUI-1
C0743284
Drug Name
Beschrijving

Trade Name preferred

Datatype

text

Alias
UMLS CUI [1]
C0013227
Route of Admin. or Formulation
Beschrijving

Route of Admin. or Formulation

Datatype

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dose
Beschrijving

Total Daily Dose

Datatype

text

Alias
UMLS CUI [1]
C2348070
Units
Beschrijving

Units

Datatype

text

Alias
UMLS CUI [1]
C1519795
Started Pre-Study
Beschrijving

Started Pre-Study

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0451613
Start Date
Beschrijving

Start Date

Datatype

date

Maateenheden
  • Day Month Year
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Day Month Year
Stop Date
Beschrijving

Stop Date

Datatype

date

Maateenheden
  • Day Month Year
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Day Month Year
Ongoing Medication
Beschrijving

Ongoing Medication

Datatype

text

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschrijving

Reason for Medication

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Study Withdrawal
Beschrijving

Study Withdrawal

Alias
UMLS CUI-1
C0422727
Was the subject withdrawn from the study as a result of this pregnancy?
Beschrijving

Study Withdrawal

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
Reporting Investigator Information
Beschrijving

Reporting Investigator Information

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1533716
Name
Beschrijving

Name

Datatype

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0027365
Title
Beschrijving

Title

Datatype

text

Alias
UMLS CUI [1]
C3888414
Speciality
Beschrijving

Speciality

Datatype

text

Alias
UMLS CUI [1,1]
C0037778
UMLS CUI [1,2]
C0008961
Address
Beschrijving

Address

Datatype

text

Alias
UMLS CUI [1]
C1442065
City or State/Province
Beschrijving

City

Datatype

text

Alias
UMLS CUI [1]
C0008848
Country
Beschrijving

Country

Datatype

text

Alias
UMLS CUI [1]
C0454664
Post or Zip Code
Beschrijving

Zip Code

Datatype

integer

Alias
UMLS CUI [1]
C0421454
Telephone No
Beschrijving

Telephone No

Datatype

integer

Alias
UMLS CUI [1]
C1515258
Fax No
Beschrijving

Fax No

Datatype

integer

Alias
UMLS CUI [1]
C1549619
Investigator’s signature
Beschrijving

confirming that the data on these pages are accurate and complete

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Investigator’s name
Beschrijving

print

Datatype

text

Alias
UMLS CUI [1]
C2826892
Terug naar het begin van de pagina

Similar models

Pregnancy Notification Form

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Subject Identification
text
C1269815 (UMLS CUI [1])
Subject Identification
Code List
Subject Identification
CL Item
Subject (Subject)
CL Item
Subject's partner (Subject's partner)
Item Group
Mother's relevant medical/family history
C0262926 (UMLS CUI-1)
C0241889 (UMLS CUI-2)
C0026591 (UMLS CUI-3)
Mother's date of birth
Item
Mother's date of birth
date
C0026591 (UMLS CUI [1,1])
C0421451 (UMLS CUI [1,2])
Date of last menstrual period
Item
Date of last menstrual period
date
C0425932 (UMLS CUI [1])
Estimated date of delivery
Item
Estimated date of delivery
date
C1287845 (UMLS CUI [1])
Was the mother using a method of contraception?
Item
Was the mother using a method of contraception?
boolean
C0700589 (UMLS CUI [1])
If Yes, specify:
Item
If Yes, specify:
text
C0700589 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Type of conception, tick one:
text
C2598844 (UMLS CUI [1])
Type of conception, tick one:
Code List
Type of conception, tick one:
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilisation) (2)
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Item
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
text
C0022885 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1456803 (UMLS CUI [2])
C0002627 (UMLS CUI [3])
C0002627 (UMLS CUI [4])
C0008509 (UMLS CUI [5])
C0332257 (UMLS CUI [6,1])
C2985720 (UMLS CUI [6,2])
Number of previous pregnancies: Pre-term
Item
Number of previous pregnancies: Pre-term
integer
C0032961 (UMLS CUI [1,1])
C1547235 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of previous pragnancies: Full-term
Item
Number of previous pragnancies: Full-term
integer
C0032961 (UMLS CUI [1,1])
C3814420 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Normal births
Item
Normal births
integer
C3665337 (UMLS CUI [1])
Stillbirths
Item
Stillbirths
integer
C0595939 (UMLS CUI [1])
Children born with defects
Item
Children born with defects
integer
C0000768 (UMLS CUI [1,1])
C2229974 (UMLS CUI [1,2])
Record details of children born with defects
Item
Record details of children born with defects
text
C1522508 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
C2229974 (UMLS CUI [1,3])
Spontaneous abortion
Item
Spontaneous abortion
integer
C0000786 (UMLS CUI [1])
Elective abortion
Item
Elective abortion
integer
C0269439 (UMLS CUI [1])
Other
Item
Other
integer
C0205394 (UMLS CUI [1,1])
C0156543 (UMLS CUI [1,2])
Are there any additional factors that may have an impact on the outcome of this pregnancy?
Item
Are there any additional factors that may have an impact on the outcome of this pregnancy?
boolean
C0032972 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
If Yes, specify
Item
If Yes, specify
text
C2348235 (UMLS CUI [1,1])
C0032972 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,3])
Item Group
Father's Relevant Medical/Family History
C0262926 (UMLS CUI-1)
C0241889 (UMLS CUI-2)
C0015671 (UMLS CUI-3)
Father's Relevant Medical/Family History
Item
Father's Relevant Medical/Family History
text
C0262926 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0015671 (UMLS CUI [1,3])
Item Group
Drug Exposures
C0743284 (UMLS CUI-1)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Route of Admin. or Formulation
Item
Route of Admin. or Formulation
text
C0013153 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Item
Started Pre-Study
text
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
Started Pre-Study
Code List
Started Pre-Study
CL Item
Yes (Y)
CL Item
No (N)
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Ongoing Medication
text
C2826666 (UMLS CUI [1])
Ongoing Medication
Code List
Ongoing Medication
CL Item
Yes (Y)
CL Item
No (N)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Study Withdrawal
C0422727 (UMLS CUI-1)
Study Withdrawal
Item
Was the subject withdrawn from the study as a result of this pregnancy?
boolean
C0422727 (UMLS CUI [1])
Item Group
Reporting Investigator Information
C0008961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Name
Item
Name
text
C0008961 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Title
Item
Title
text
C3888414 (UMLS CUI [1])
Speciality
Item
Speciality
text
C0037778 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Address
Item
Address
text
C1442065 (UMLS CUI [1])
City
Item
City or State/Province
text
C0008848 (UMLS CUI [1])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Zip Code
Item
Post or Zip Code
integer
C0421454 (UMLS CUI [1])
Telephone No
Item
Telephone No
integer
C1515258 (UMLS CUI [1])
Fax No
Item
Fax No
integer
C1549619 (UMLS CUI [1])
Investigator signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Terug naar het begin van de pagina 

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