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ID

23863

Beschrijving

Study part: Pregnancy Notification Form (Subject) Week 36/ Early Withdrawal Visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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  1. 15-07-17 15-07-17 -
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GlaxoSmithKline

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15 juli 2017

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Creative Commons BY-NC 3.0
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    Pregnancy Notification Form (Subject) Week 36 Mepolizumab HES NCT00086658

    Engels

    Pregnancy Notification Form (Subject) Week 36

    1 Formulieren  
    MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
    Beschrijving

    MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY

    Alias
    UMLS CUI-1
    C0241889
    UMLS CUI-2
    C0026591
    Subject ID
    Beschrijving

    Subject ID

    Datatype

    text

    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]
    C0449788
    UMLS CUI [1,2]
    C0034656
    Mother’s date of birth
    Beschrijving

    date of birth mother

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0421451
    UMLS CUI [1,2]
    C0026591
    Date of last menstrual period
    Beschrijving

    Date of last menstrual period

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0425932
    Estimated date of delivery
    Beschrijving

    Estimated date of delivery

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1287845
    Was the mother using a method of contraception?
    Beschrijving

    method of contraception

    Datatype

    boolean

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

    method of contraception

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0700589
    Type of conception
    Beschrijving

    Type of conception

    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

    laboratory tests

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0022885
    Number of previous pregnancies-Pre-term
    Beschrijving

    Number of previous pregnancies Pre-term

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0422807
    UMLS CUI [1,2]
    C1547235
    Number of previous pregnancies-Full-term
    Beschrijving

    Number of previous pregnancies Full-term

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0422807
    UMLS CUI [1,2]
    C3814420
    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
    Spontaneous abortion
    Beschrijving

    Spontaneous abortion

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0000786
    Elective abortion
    Beschrijving

    Elective abortion

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0269439
    If other, please specify
    Beschrijving

    Other

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0205394
    Record details of children born with defects
    Beschrijving

    Children born with defects

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C2229974
    Are there any additional factors that may have an impact on the outcome of this pregnancy?
    Beschrijving

    pregnancy outcome

    Datatype

    text

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

    pregnancy outcome

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0032972
    FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
    Beschrijving

    FATHER’S RELEVANT MEDICAL/FAMILY HISTORY

    Alias
    UMLS CUI-1
    C0241889
    UMLS CUI-2
    C0015671
    FATHER’S RELEVANT MEDICAL/FAMILY HISTORY (Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/chromosomal disorders and medication use)
    Beschrijving

    Family history father substance use disorder

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0241889
    UMLS CUI [1,2]
    C0015671
    UMLS CUI [1,3]
    C0038586
    Drug Name
    Beschrijving

    Drug Name

    Datatype

    text

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

    Route

    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

    boolean

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

    Start Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0808070
    Stop Date
    Beschrijving

    Stop Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0806020
    Ongoing Medication
    Beschrijving

    Ongoing Medication

    Datatype

    boolean

    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
    Was the subject withdrawn from the study as a result of this pregnancy?
    Beschrijving

    withdrawn from the study

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    REPORTING INVESTIGATOR INFORMATION
    Beschrijving

    REPORTING INVESTIGATOR INFORMATION

    Alias
    UMLS CUI-1
    C1955348
    UMLS CUI-2
    C0008961
    Name
    Beschrijving

    Name

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0008961
    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

    Investigator signature

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator’s name
    Beschrijving

    Investigator name

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008
    Terug naar het begin van de pagina

    Similar models

    Pregnancy Notification Form (Subject) Week 36

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    MOTHER’S RELEVANT MEDICAL/FAMILY HISTORY
    C0241889 (UMLS CUI-1)
    C0026591 (UMLS CUI-2)
    Subject ID
    Item
    Subject ID
    text
    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
    C0449788 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    date of birth mother
    Item
    Mother’s date of birth
    date
    C0421451 (UMLS CUI [1,1])
    C0026591 (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])
    method of contraception
    Item
    Was the mother using a method of contraception?
    boolean
    C0700589 (UMLS CUI [1])
    method of contraception
    Item
    If Yes, specify
    text
    C0700589 (UMLS CUI [1])
    Item
    Type of conception
    text
    C2598844 (UMLS CUI [1])
    Type of conception
    Code List
    Type of conception
    CL Item
    Normal (includes use of fertility drugs) (Normal (includes use of fertility drugs))
    CL Item
    IVF (in vitro fertilisation) (IVF (in vitro fertilisation))
    C0015915 (UMLS CUI-1)
    laboratory tests
    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])
    Number of previous pregnancies Pre-term
    Item
    Number of previous pregnancies-Pre-term
    integer
    C0422807 (UMLS CUI [1,1])
    C1547235 (UMLS CUI [1,2])
    Number of previous pregnancies Full-term
    Item
    Number of previous pregnancies-Full-term
    integer
    C0422807 (UMLS CUI [1,1])
    C3814420 (UMLS CUI [1,2])
    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])
    Spontaneous abortion
    Item
    Spontaneous abortion
    integer
    C0000786 (UMLS CUI [1])
    Elective abortion
    Item
    Elective abortion
    integer
    C0269439 (UMLS CUI [1])
    Other
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1])
    Children born with defects
    Item
    Record details of children born with defects
    text
    C0000768 (UMLS CUI [1,1])
    C2229974 (UMLS CUI [1,2])
    pregnancy outcome
    Item
    Are there any additional factors that may have an impact on the outcome of this pregnancy?
    text
    C0032972 (UMLS CUI [1])
    pregnancy outcome
    Item
    If Yes, specify
    text
    C0032972 (UMLS CUI [1])
    Item Group
    FATHER’S RELEVANT MEDICAL/FAMILY HISTORY
    C0241889 (UMLS CUI-1)
    C0015671 (UMLS CUI-2)
    Family history father substance use disorder
    Item
    FATHER’S RELEVANT MEDICAL/FAMILY HISTORY (Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/chromosomal disorders and medication use)
    text
    C0241889 (UMLS CUI [1,1])
    C0015671 (UMLS CUI [1,2])
    C0038586 (UMLS CUI [1,3])
    Drug Name
    Item
    Drug Name
    text
    C0013227 (UMLS CUI [1])
    Route
    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])
    Started Pre-Study
    Item
    Started Pre-Study
    boolean
    C0013227 (UMLS CUI [1,1])
    C0451613 (UMLS CUI [1,2])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Ongoing Medication
    Item
    Ongoing Medication
    boolean
    C2826666 (UMLS CUI [1])
    Reason for Medication
    Item
    Reason for Medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    withdrawn from the study
    Item
    Was the subject withdrawn from the study as a result of this pregnancy?
    boolean
    C0422727 (UMLS CUI [1])
    Item Group
    REPORTING INVESTIGATOR INFORMATION
    C1955348 (UMLS CUI-1)
    C0008961 (UMLS CUI-2)
    Name
    Item
    Name
    text
    C0008961 (UMLS CUI [1])
    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])
    Investigator name
    Item
    Investigator’s name
    text
    C2826892 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
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