0 Evaluaciones
ID

34512

Descripción

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.

Palabras clave

Versiones (2)
  1. 14/1/19 14/1/19 -
  2. 18/1/19 18/1/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

18 de enero de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

    Inglés

    Pregnancy Notification Form

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descripción

    Subject Identifier

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Descripción

    Centre Number

    Tipo de datos

    integer

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

    Randomisation Number

    Tipo de datos

    integer

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

    Subject Identification

    Tipo de datos

    text

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

    Mother's relevant medical/family history

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

    Mother's date of birth

    Tipo de datos

    date

    Unidades de medida
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0026591
    UMLS CUI [1,2]
    C0421451
    Day Month Year
    Date of last menstrual period
    Descripción

    Date of last menstrual period

    Tipo de datos

    date

    Unidades de medida
    • Day Month Year
    Alias
    UMLS CUI [1]
    C0425932
    Day Month Year
    Estimated date of delivery
    Descripción

    Estimated date of delivery

    Tipo de datos

    date

    Unidades de medida
    • Day Month Year
    Alias
    UMLS CUI [1]
    C1287845
    Day Month Year
    Was the mother using a method of contraception?
    Descripción

    Was the mother using a method of contraception?

    Tipo de datos

    boolean

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

    If Yes, specify:

    Tipo de datos

    text

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

    Type of conception, tick one:

    Tipo de datos

    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).
    Descripción

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

    Tipo de datos

    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
    Descripción

    If applicable, record the number in the appropriate categories below

    Tipo de datos

    integer

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

    If applicable, record the number in the appropriate categories below

    Tipo de datos

    integer

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

    Normal births

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3665337
    Stillbirths
    Descripción

    Stillbirths

    Tipo de datos

    integer

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

    Children born with defects

    Tipo de datos

    integer

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

    Record details of children born with defects

    Tipo de datos

    text

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

    Spontaneous abortion

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0000786
    Elective abortion
    Descripción

    Elective abortion

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0269439
    Other
    Descripción

    Other

    Tipo de datos

    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?
    Descripción

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

    Tipo de datos

    boolean

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

    If Yes, specify

    Tipo de datos

    text

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

    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
    Descripción

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

    Tipo de datos

    text

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

    Drug Exposures

    Alias
    UMLS CUI-1
    C0743284
    Drug Name
    Descripción

    Trade Name preferred

    Tipo de datos

    text

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

    Route of Admin. or Formulation

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013153
    Total Daily Dose
    Descripción

    Total Daily Dose

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348070
    Units
    Descripción

    Units

    Tipo de datos

    text

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

    Started Pre-Study

    Tipo de datos

    text

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

    Start Date

    Tipo de datos

    date

    Unidades de medida
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    Day Month Year
    Stop Date
    Descripción

    Stop Date

    Tipo de datos

    date

    Unidades de medida
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Day Month Year
    Ongoing Medication
    Descripción

    Ongoing Medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826666
    Reason for Medication
    Descripción

    Reason for Medication

    Tipo de datos

    text

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

    Study Withdrawal

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

    Study Withdrawal

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Reporting Investigator Information
    Descripción

    Reporting Investigator Information

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

    Name

    Tipo de datos

    text

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

    Title

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3888414
    Speciality
    Descripción

    Speciality

    Tipo de datos

    text

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

    Address

    Tipo de datos

    text

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

    City

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0008848
    Country
    Descripción

    Country

    Tipo de datos

    text

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

    Zip Code

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0421454
    Telephone No
    Descripción

    Telephone No

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1515258
    Fax No
    Descripción

    Fax No

    Tipo de datos

    integer

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

    confirming that the data on these pages are accurate and complete

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Descripción

    Date

    Tipo de datos

    date

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

    print

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826892
    Volver a la parte superior de la página

    Similar models

    Pregnancy Notification Form

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

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