ID

34512

Description

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.

Keywords

Versions (2)
  1. 1/14/19 1/14/19 -
  2. 1/18/19 1/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 18, 2019

DOI

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License

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

English

Pregnancy Notification Form

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

integer

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

Randomisation Number

Data type

integer

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

Subject Identification

Data type

text

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

Mother's relevant medical/family history

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

Mother's date of birth

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0421451
Day Month Year
Date of last menstrual period
Description

Date of last menstrual period

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1]
C0425932
Day Month Year
Estimated date of delivery
Description

Estimated date of delivery

Data type

date

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

Was the mother using a method of contraception?

Data type

boolean

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

If Yes, specify:

Data type

text

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

Type of conception, tick one:

Data type

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).
Description

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

Data type

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
Description

If applicable, record the number in the appropriate categories below

Data type

integer

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

If applicable, record the number in the appropriate categories below

Data type

integer

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

Normal births

Data type

integer

Alias
UMLS CUI [1]
C3665337
Stillbirths
Description

Stillbirths

Data type

integer

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

Children born with defects

Data type

integer

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

Record details of children born with defects

Data type

text

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

Spontaneous abortion

Data type

integer

Alias
UMLS CUI [1]
C0000786
Elective abortion
Description

Elective abortion

Data type

integer

Alias
UMLS CUI [1]
C0269439
Other
Description

Other

Data type

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?
Description

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

Data type

boolean

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

If Yes, specify

Data type

text

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

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
Description

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

Data type

text

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

Drug Exposures

Alias
UMLS CUI-1
C0743284
Drug Name
Description

Trade Name preferred

Data type

text

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

Route of Admin. or Formulation

Data type

text

Alias
UMLS CUI [1]
C0013153
Total Daily Dose
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Units
Description

Units

Data type

text

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

Started Pre-Study

Data type

text

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

Start Date

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Day Month Year
Stop Date
Description

Stop Date

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Day Month Year
Ongoing Medication
Description

Ongoing Medication

Data type

text

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Description

Reason for Medication

Data type

text

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

Study Withdrawal

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

Study Withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Reporting Investigator Information
Description

Reporting Investigator Information

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

Name

Data type

text

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

Title

Data type

text

Alias
UMLS CUI [1]
C3888414
Speciality
Description

Speciality

Data type

text

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

Address

Data type

text

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

City

Data type

text

Alias
UMLS CUI [1]
C0008848
Country
Description

Country

Data type

text

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

Zip Code

Data type

integer

Alias
UMLS CUI [1]
C0421454
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
Investigator’s signature
Description

confirming that the data on these pages are accurate and complete

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

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

print

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 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])
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