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ID

33375

Descrizione

Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the Pregnancy notification form (subject's partner). Complete this form for each subject's partner who becomes pregnant during the study period. 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. 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.

collegamento

https://clinicaltrials.gov/ct2/show/NCT00599612

Keywords

versioni (2)
  1. 07/12/18 07/12/18 -
  2. 07/12/18 07/12/18 - Sarah Riepenhausen
Titolare del copyright

GlaxoSmithKline

Caricato su

7 dicembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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    Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612

    Inglese

    Pregnancy notification form (subject's partner)

    1 moduli  
    Administrative data
    Descrizione

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject identifier
    Descrizione

    Subject identifier

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585
    Mothers relevant medical/family history
    Descrizione

    Mothers relevant medical/family history

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

    day month year

    Tipo di dati

    date

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

    day month year

    Tipo di dati

    date

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

    day month year

    Tipo di dati

    boolean

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

    Use of a method of contraception

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1524063
    UMLS CUI [1,2]
    C0700589
    If "useof a method of contraception", please specify
    Descrizione

    Method of contraception

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0700589
    Type of conception
    Descrizione

    Tick one

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2598844
    Relevant laboratory tests and procedures
    Descrizione

    (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures). Please note for each date of test and procedure.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0032961
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C0011008
    UMLS CUI [3]
    C0041618
    UMLS CUI [4,1]
    C0002627
    UMLS CUI [4,2]
    C0870078
    UMLS CUI [5]
    C0008509
    Number of previous pregnancies
    Descrizione

    Number of previous pregnancies

    Alias
    UMLS CUI-1
    C0422807
    Number of Pre-term
    Descrizione

    Number of Pre-term

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0151526
    UMLS CUI [1,2]
    C0449788
    Number of Full-term
    Descrizione

    Number of Full-term

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C3814420
    UMLS CUI [1,2]
    C0449788
    Number of Normal births
    Descrizione

    If applicable, record the number in the appropriate categories

    Tipo di dati

    integer

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

    If applicable, record the number in the appropriate categories

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0595939
    UMLS CUI [1,2]
    C0449788
    Number of Children born with defects
    Descrizione

    If applicable, record the number in the appropriate categories

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0000768
    UMLS CUI [1,2]
    C0449788
    Number of Spontaneous abortion
    Descrizione

    If applicable, record the number in the appropriate categories

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0000786
    UMLS CUI [1,2]
    C0449788
    Number of Elective abortion
    Descrizione

    If applicable, record the number in the appropriate categories

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0269439
    UMLS CUI [1,2]
    C0449788
    Number of Other birth types
    Descrizione

    Number of Other birth types

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C0449788
    If children born with defects, please record details
    Descrizione

    Children born with defects

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0008059
    UMLS CUI [1,2]
    C0000768
    Are there any additional factors that may have an impact on the outcome of this pregnancy?
    Descrizione

    Additional factors impacting outcome of pregnancy

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0035648
    UMLS CUI [1,2]
    C0032972
    If you tick yes for "additional factors", please specify
    Descrizione

    Specification of factors

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2348235
    UMLS CUI [1,2]
    C0035648
    Fathers relevant medical/family history
    Descrizione

    Fathers relevant medical/family history

    Alias
    UMLS CUI-1
    C0015671
    UMLS CUI-2
    C0262926
    UMLS CUI-3
    C0241889
    Medical/family history
    Descrizione

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

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0241889
    DRUG EXPOSURES
    Descrizione

    DRUG EXPOSURES

    Alias
    UMLS CUI-1
    C0743284
    Drug Name
    Descrizione

    (Trade Name preferred)

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2360065
    Route of Administration or Formulation
    Descrizione

    Route of Administration or Formulation

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0013153
    Total Daily Dose
    Descrizione

    Total Daily Dose

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348070
    Units of Total Daily Dose
    Descrizione

    Units of Total Daily Dose

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C1519795
    Started Pre-study
    Descrizione

    Started Pre-study

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C2347804
    Start date
    Descrizione

    day month year

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C0808070
    Stop date
    Descrizione

    day month year

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C0806020
    Ongoing Medication
    Descrizione

    Ongoing Medication

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826666
    Reason for Medication
    Descrizione

    Reason for Medication

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Withdraw from study
    Descrizione

    Withdraw from study

    Alias
    UMLS CUI-1
    C2349954
    Was the subject withdrawn from the study as a result of this pregnancy?
    Descrizione

    Withdraw

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2349954
    REPORTING INVESTIGATOR INFORMATION
    Descrizione

    REPORTING INVESTIGATOR INFORMATION

    Alias
    UMLS CUI-1
    C1955348
    UMLS CUI-2
    C0008961
    Name of investigator
    Descrizione

    Name of investigator

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826892
    Title of investigator
    Descrizione

    Title of investigator

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3888414
    UMLS CUI [1,2]
    C0008961
    Speciality of investigator
    Descrizione

    Speciality of investigator

    Tipo di dati

    text

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

    Address

    Tipo di dati

    text

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

    City or State/Province

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0008848
    UMLS CUI [1,2]
    C1547742
    Country
    Descrizione

    Country

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0454664
    Post or Zip code
    Descrizione

    Post or Zip code

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1514254
    UMLS CUI [1,2]
    C0600091
    Telephone No
    Descrizione

    Telephone No

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1515258
    Fax No
    Descrizione

    Fax No

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1549619
    Date of signature
    Descrizione

    day month year

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C0807937
    Investigator's signature
    Descrizione

    Confirming that the data on these page are accurate and complete.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's name (print)
    Descrizione

    Investigator's name (print)

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2826892
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    Similar models

    Pregnancy notification form (subject's partner)

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Mothers 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
    boolean
    C1287845 (UMLS CUI [1])
    Item
    Was the mother using a method of contraception?
    text
    C1524063 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Use of a method of contraception
    Code List
    Was the mother using a method of contraception?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Method of contraception
    Item
    If "useof a method of contraception", please specify
    text
    C0700589 (UMLS CUI [1])
    Item
    Type of conception
    integer
    C2598844 (UMLS CUI [1])
    Type of conception
    Code List
    Type of conception
    CL Item
    Normal (includes use of fertility drugs) (1)
    CL Item
    IVF (in vitro fertilisation) (2)
    Relevant laboratory tests and procedures
    Item
    Relevant laboratory tests and procedures
    text
    C0022885 (UMLS CUI [1,1])
    C0032961 (UMLS CUI [1,2])
    C0022885 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    C0041618 (UMLS CUI [3])
    C0002627 (UMLS CUI [4,1])
    C0870078 (UMLS CUI [4,2])
    C0008509 (UMLS CUI [5])
    Item Group
    Number of previous pregnancies
    C0422807 (UMLS CUI-1)
    Number of Pre-term
    Item
    Number of Pre-term
    integer
    C0151526 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Number of Full-term
    Item
    Number of Full-term
    integer
    C3814420 (UMLS CUI [1,1])
    C0449788 (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])
    Number of Spontaneous abortion
    Item
    Number of Spontaneous abortion
    integer
    C0000786 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Number of Elective abortion
    Item
    Number of Elective abortion
    integer
    C0269439 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Number of Other birth types
    Item
    Number of Other birth types
    integer
    C0205394 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    Children born with defects
    Item
    If children born with defects, please record details
    text
    C0008059 (UMLS CUI [1,1])
    C0000768 (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])
    C0032972 (UMLS CUI [1,2])
    Additional factors impacting outcome of pregnancy
    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)
    Specification of factors
    Item
    If you tick yes for "additional factors", please specify
    text
    C2348235 (UMLS CUI [1,1])
    C0035648 (UMLS CUI [1,2])
    Item Group
    Fathers relevant medical/family history
    C0015671 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    C0241889 (UMLS CUI-3)
    Medical/family history
    Item
    Medical/family history
    text
    C0262926 (UMLS CUI [1,1])
    C0241889 (UMLS CUI [1,2])
    Item Group
    DRUG EXPOSURES
    C0743284 (UMLS CUI-1)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    Route of Administration or Formulation
    Item
    Route of Administration or Formulation
    text
    C0013153 (UMLS CUI [1])
    Total Daily Dose
    Item
    Total Daily Dose
    integer
    C2348070 (UMLS CUI [1])
    Units of Total Daily Dose
    Item
    Units of Total Daily Dose
    text
    C2348070 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Item
    Started Pre-study
    text
    C0808070 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Started Pre-study
    Code List
    Started Pre-study
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1])
    Stop date
    Item
    Stop date
    date
    C0806020 (UMLS CUI [1])
    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
    Withdraw from study
    C2349954 (UMLS CUI-1)
    Item
    Was the subject withdrawn from the study as a result of this pregnancy?
    text
    C2349954 (UMLS CUI [1])
    Withdraw
    Code List
    Was the subject withdrawn from the study as a result of this pregnancy?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    REPORTING INVESTIGATOR INFORMATION
    C1955348 (UMLS CUI-1)
    C0008961 (UMLS CUI-2)
    Name of investigator
    Item
    Name of investigator
    text
    C2826892 (UMLS CUI [1])
    Title of investigator
    Item
    Title of investigator
    text
    C3888414 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Speciality of investigator
    Item
    Speciality of investigator
    text
    C0008961 (UMLS CUI [1,1])
    C0037778 (UMLS CUI [1,2])
    Address
    Item
    Address
    text
    C1442065 (UMLS CUI [1])
    City or State/Province
    Item
    City or State/Province
    text
    C0008848 (UMLS CUI [1,1])
    C1547742 (UMLS CUI [1,2])
    Country
    Item
    Country
    text
    C0454664 (UMLS CUI [1])
    Post or Zip code
    Item
    Post or Zip code
    text
    C1514254 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Telephone No
    Item
    Telephone No
    integer
    C1515258 (UMLS CUI [1])
    Fax No
    Item
    Fax No
    integer
    C1549619 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C0807937 (UMLS CUI [1])
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Investigator's name (print)
    Item
    Investigator's name (print)
    text
    C2826892 (UMLS CUI [1])
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