0 Bedömningar
ID

41229

Beskrivning

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the end of study document within the Study conclusion, death and pregnancy information. It has to be filled in for the Follow-up visit.

Länk

https://clinicaltrials.gov/ct2/show/NCT00821054

Nyckelord

Versioner (1)
  1. 2020-07-20 2020-07-20 - Christian Arras
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

20 juli 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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    Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

    Engelsk

    End of Study

    1 Formulär  
    1. StudyEvent: ODM
      1. End of Study
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Visit Date
    Beskrivning

    Date of Visit

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject number
    Beskrivning

    Subject number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Study Conclusion
    Beskrivning

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Date of subject completion or withdrawal
    Beskrivning

    Study End Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2983670
    Was the subject withdrawn from the study?
    Beskrivning

    Patient withdrawn from trial

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0422727
    If withdrawn from the study, please complete the primary reason:
    Beskrivning

    If Adverse Event, please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Select Investigator discretion as reason if none of the other primary reasons are appropriate.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    If investigator discretion, please specify:
    Beskrivning

    Clinical Investigators Judgment, specify

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2348235
    UMLS CUI [1,2]
    C0008961
    UMLS CUI [1,3]
    C0022423
    Will the subject enter the extension study?
    Beskrivning

    Study subject participation status, extension study

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0231448
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C2348568
    Case book ready for signature
    Beskrivning

    hidden/not required. Data owner should check the box when data cleaning is complete.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1706256
    UMLS CUI [1,2]
    C1519316
    Office use 1
    Beskrivning

    hidden

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0442603
    Office use 2
    Beskrivning

    hidden

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0442603
    Death
    Beskrivning

    Death

    Alias
    UMLS CUI-1
    C0011065
    Is the subject alive?
    Beskrivning

    Alive

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2584946
    If the subject is dead, enter date of death:
    Beskrivning

    date of death

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1148348
    If the subject is dead, indicate the primary cause of death:
    Beskrivning

    cause of death

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0007465
    If other cause of death, please specify
    Beskrivning

    other cause of death, to specify

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0007465
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Pregnancy information (Preg)
    Beskrivning

    Pregnancy information (Preg)

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant during the study?
    Beskrivning

    If Yes, complete the paper Pregnancy Notification form.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3828490
    Pregnancy Information (Preg M)
    Beskrivning

    Pregnancy Information (Preg M)

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    UMLS CUI-3
    C0086582
    Did a female partner of the male subject become pregnant during the study?
    Beskrivning

    If Yes, complete the paper Pregnancy Notification form. Check Not Applicable if female partner not of childbearing potential or no female partner.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0919624
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008972
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    Similar models

    End of Study

    1 Formulär
    1. StudyEvent: ODM
      1. End of Study
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Date of Visit
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Study End Date
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    Item
    Was the subject withdrawn from the study?
    text
    C0422727 (UMLS CUI [1])
    Patient withdrawn from trial
    Code List
    Was the subject withdrawn from the study?
    CL Item
    No (N)
    CL Item
    Yes, complete primary reason for withdrawal (Y)
    Item
    If withdrawn from the study, please complete the primary reason:
    integer
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    reason, withdrawn from study
    Code List
    If withdrawn from the study, please complete the primary reason:
    CL Item
    Adverse Event (1)
    CL Item
    Protocol deviation (3)
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to Follow-up (6)
    CL Item
    Investigator discretion, specify (7)
    CL Item
    Withdrew consent (8)
    Clinical Investigators Judgment, specify
    Item
    If investigator discretion, please specify:
    text
    C2348235 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    C0022423 (UMLS CUI [1,3])
    Item
    Will the subject enter the extension study?
    text
    C0231448 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    Will the subject enter the extension study?
    Code List
    Will the subject enter the extension study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Case book ready for signature
    text
    C1706256 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Clinical study case, signature
    Code List
    Case book ready for signature
    CL Item
    Yes (Y)
    Item
    Office use 1
    text
    C0442603 (UMLS CUI [1])
    Office use
    Code List
    Office use 1
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item
    Office use 2
    integer
    C0442603 (UMLS CUI [1])
    Office use
    Code List
    Office use 2
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    Item Group
    Death
    C0011065 (UMLS CUI-1)
    Item
    Is the subject alive?
    text
    C2584946 (UMLS CUI [1])
    Alive
    Code List
    Is the subject alive?
    CL Item
    Yes (Y)
    CL Item
    No, enter date of death and indicate the primary cause of death: (N)
    date of death
    Item
    If the subject is dead, enter date of death:
    date
    C1148348 (UMLS CUI [1])
    Item
    If the subject is dead, indicate the primary cause of death:
    text
    C0007465 (UMLS CUI [1])
    cause of death
    Code List
    If the subject is dead, indicate the primary cause of death:
    CL Item
    Disease under study (1)
    CL Item
    Haematologic toxicity (2)
    CL Item
    Non-haematologic toxicity (3)
    CL Item
    Other, specify (OT)
    other cause of death, to specify
    Item
    If other cause of death, please specify
    text
    C0007465 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item Group
    Pregnancy information (Preg)
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Did the subject become pregnant during the study?
    text
    C3828490 (UMLS CUI [1])
    Pregnant during the study
    Code List
    Did the subject become pregnant during the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Item Group
    Pregnancy Information (Preg M)
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    C0086582 (UMLS CUI-3)
    Item
    Did a female partner of the male subject become pregnant during the study?
    text
    C0919624 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008972 (UMLS CUI [1,3])
    Pregnancy of partner, during clinical research
    Code List
    Did a female partner of the male subject become pregnant during the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    CL Item
    Not Applicable (X)
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