0 Ratings
ID

30929

Description

This ODM file contains pregnancy notification form for the female partner of a male subject as well as a female subject. This form should be completed according to the protocol reporting requirements. Complete this form for each subject(’s partner) 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. All of the header information must be completed before sending back to GSK. 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. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Link

https://clinicaltrials.gov/ct2/show/NCT01039454

Keywords

Versions (2)
  1. 03/07/18 03/07/18 - Sarah Riepenhausen
  2. 03/07/18 03/07/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

3 luglio 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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    Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

    English

    Pregnancy Notification Form

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Protocol Identifier
    Description

    Protocol Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C4331034
    Centre number
    Description

    Centre number

    Data type

    text

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

    Randomisation Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Who is pregnant? Subject or Subject's Partner?
    Description

    Pregnant Person

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C1997894
    UMLS CUI [2,1]
    C0032961
    UMLS CUI [2,2]
    C0682323
    Mother's relevant medical/family history
    Description

    Mother's relevant medical/family history

    Alias
    UMLS CUI-1
    C0026591
    UMLS CUI-2
    C0262926
    UMLS CUI-3
    C0241889
    Mother's Date of Birth
    Description

    Mother's Date of Birth

    Data type

    date

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

    Date of last menstrual period

    Data type

    date

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

    Estimated date of delivery

    Data type

    date

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

    Contraception

    Data type

    text

    Alias
    UMLS CUI [1]
    C0420837
    If Yes, specify
    Description

    Method of Contraception

    Data type

    text

    Alias
    UMLS CUI [1]
    C0700589
    Type of Conception
    Description

    Type of Conception

    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

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0032961
    UMLS CUI [2,1]
    C0430022
    UMLS CUI [2,2]
    C0032961
    Number of Previous Pre-term pregnancies
    Description

    Number of Previous Pre-term pregnancies

    Data type

    integer

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

    Number of Previous Full-term pregnancies

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0422807
    UMLS CUI [1,2]
    C3814420
    Number of normal births
    Description

    Number of normal births

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3665337
    UMLS CUI [1,2]
    C0449788
    Number of Stillbirths
    Description

    Number of Stillbirths

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0595939
    UMLS CUI [1,2]
    C0449788
    Number of children born with defects
    Description

    Number of children born with defects

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C0449788
    Record details of children born with defects
    Description

    Details of birth defects in children

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1522508
    UMLS CUI [1,2]
    C0000768
    Number of Spontaneous abortions
    Description

    Number of Spontaneous abortions

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0000786
    UMLS CUI [1,2]
    C0449788
    Number of Elective Abortions
    Description

    Number of Elective Abortions

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0269439
    UMLS CUI [1,2]
    C0449788
    Number of other pregnancies/births
    Description

    Number of other pregnancies/births

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0422807
    UMLS CUI [1,2]
    C0205394
    Are there any additional factors that may have an impact on the outcome of this pregnancy?
    Description

    additional risk factors for this pregnancy

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0035648
    UMLS CUI [1,2]
    C0747843
    If yes, specify
    Description

    additional risk factors for this pregnancy, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0035648
    UMLS CUI [1,2]
    C0747843
    UMLS CUI [1,3]
    C1521902
    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
    UMLS CUI-2
    C0032961
    Drug Name
    Description

    Trade Name preferred. List all medications (including study medications) the subject received during the study period (e.g. prescription, OTC, vaccines, recreational, alcohol, etc.) and fill out the other items of this itemgroup for each drug. Enter the investigational product details on the first line (if the investigational product is blinded, enter ’Investigational Product’ on this line). If there are extensive concomitant medications, attach a copy of the Concomitant Medications CRF page.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C0013227
    Route of Admin. or Formulation
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Total Daily Dose
    Description

    Total Daily Dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0013227
    Units
    Description

    Units

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519795
    UMLS CUI [1,2]
    C0013227
    Started Pre-Study
    Description

    Started Pre-Study

    Data type

    boolean

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

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Ongoing Medication
    Description

    Ongoing Medication

    Data type

    boolean

    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
    Subject withdrawal
    Description

    Subject withdrawal

    Alias
    UMLS CUI-1
    C0422727
    UMLS CUI-2
    C0032961
    Was the subject withdrawn from the study as a result of this pregnancy?
    Description

    Subject withdrawal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0032961
    REPORTING INVESTIGATOR INFORMATION
    Description

    REPORTING INVESTIGATOR INFORMATION

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

    Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Title
    Description

    Title

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3888414
    UMLS CUI [1,2]
    C0008961
    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 [1,1]
    C1442065
    UMLS CUI [1,2]
    C0008961
    City or State/Province
    Description

    City

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008848
    UMLS CUI [1,2]
    C0008961
    Country
    Description

    Country

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0454664
    UMLS CUI [1,2]
    C0008961
    Post or Zip Code
    Description

    Zip Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0421454
    UMLS CUI [1,2]
    C0008961
    Telephone No
    Description

    Telephone No

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1515258
    UMLS CUI [1,2]
    C0008961
    Fax No
    Description

    Fax No

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1549619
    UMLS CUI [1,2]
    C0008961
    Investigator’s signature confirming that the data on these pages are accurate and complete
    Description

    Investigator signature

    Data type

    text

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

    Investigator name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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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
    text
    C2348585 (UMLS CUI [1])
    Protocol Identifier
    Item
    Protocol Identifier
    text
    C4331034 (UMLS CUI [1])
    Centre number
    Item
    Centre number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Randomisation Number
    Item
    Randomisation Number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item
    Who is pregnant? Subject or Subject's Partner?
    text
    C0032961 (UMLS CUI [1,1])
    C1997894 (UMLS CUI [1,2])
    C0032961 (UMLS CUI [2,1])
    C0682323 (UMLS CUI [2,2])
    Pregnant Person
    Code List
    Who is pregnant? Subject or Subject's Partner?
    CL Item
    Subject (Subject)
    CL Item
    Subject's Partner (Subject's Partner)
    Item Group
    Mother's relevant medical/family history
    C0026591 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    C0241889 (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])
    Item
    Was the mother using a method of contraception?
    text
    C0420837 (UMLS CUI [1])
    Contraception
    Code List
    Was the mother using a method of contraception?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    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))
    Relevant laboratory 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])
    C0032961 (UMLS CUI [1,2])
    C0430022 (UMLS CUI [2,1])
    C0032961 (UMLS CUI [2,2])
    Number of Previous Pre-term pregnancies
    Item
    Number of Previous Pre-term pregnancies
    integer
    C0422807 (UMLS CUI [1,1])
    C1547235 (UMLS CUI [1,2])
    Number of Previous Full-term pregnancies
    Item
    Number of Previous Full-term pregnancies
    integer
    C0422807 (UMLS CUI [1,1])
    C3814420 (UMLS CUI [1,2])
    Number of normal births
    Item
    Number of normal births
    integer
    C3665337 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Number of Stillbirths
    Item
    Number of Stillbirths
    integer
    C0595939 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Number of children born with defects
    Item
    Number of children born with defects
    integer
    C0000768 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Details of birth defects in children
    Item
    Record details of children born with defects
    text
    C1522508 (UMLS CUI [1,1])
    C0000768 (UMLS CUI [1,2])
    Number of Spontaneous abortions
    Item
    Number of Spontaneous abortions
    integer
    C0000786 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Number of Elective Abortions
    Item
    Number of Elective Abortions
    integer
    C0269439 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Number of other pregnancies/births
    Item
    Number of other pregnancies/births
    integer
    C0422807 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item
    Are there any additional factors that may have an impact on the outcome of this pregnancy?
    text
    C0035648 (UMLS CUI [1,1])
    C0747843 (UMLS CUI [1,2])
    Contraception
    Code List
    Are there any additional factors that may have an impact on the outcome of this pregnancy?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    additional risk factors for this pregnancy, specify
    Item
    If yes, specify
    text
    C0035648 (UMLS CUI [1,1])
    C0747843 (UMLS CUI [1,2])
    C1521902 (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)
    C0032961 (UMLS CUI-2)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Route
    Item
    Route of Admin. or Formulation
    text
    C0013153 (UMLS CUI [1])
    Total Daily Dose
    Item
    Total Daily Dose
    text
    C2348070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Units
    Item
    Units
    text
    C1519795 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Started Pre-Study
    Item
    Started Pre-Study
    boolean
    C0013227 (UMLS CUI [1,1])
    C0451613 (UMLS CUI [1,2])
    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])
    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])
    Item Group
    Subject withdrawal
    C0422727 (UMLS CUI-1)
    C0032961 (UMLS CUI-2)
    Item
    Was the subject withdrawn from the study as a result of this pregnancy?
    text
    C0422727 (UMLS CUI [1,1])
    C0032961 (UMLS CUI [1,2])
    Subject withdrawal
    Code List
    Was the subject withdrawn from the study as a result of this pregnancy?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item Group
    REPORTING INVESTIGATOR INFORMATION
    C1955348 (UMLS CUI-1)
    C0008961 (UMLS CUI-2)
    Name
    Item
    Name
    text
    C2826892 (UMLS CUI [1])
    Title
    Item
    Title
    text
    C3888414 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Speciality
    Item
    Speciality
    text
    C0037778 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Address
    Item
    Address
    text
    C1442065 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    City
    Item
    City or State/Province
    text
    C0008848 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Country
    Item
    Country
    text
    C0454664 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Zip Code
    Item
    Post or Zip Code
    text
    C0421454 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Telephone No
    Item
    Telephone No
    integer
    C1515258 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Fax No
    Item
    Fax No
    integer
    C1549619 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Investigator signature
    Item
    Investigator’s signature confirming that the data on these pages are accurate and complete
    text
    C2346576 (UMLS CUI [1])
    Investigator name
    Item
    Investigator’s name
    text
    C2826892 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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