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ID

41229

Description

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.

Lien

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

Mots-clés

Versions (1)
  1. 20/07/2020 20/07/2020 - Christian Arras
Détendeur de droits

GlaxoSmithKline

Téléchargé le

20 juillet 2020

DOI

Pour une demande vous connecter.

Licence

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

    Anglais

    End of Study

    1 Formulaires  
    1. StudyEvent: ODM
      1. End of Study
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Visit Date
    Description

    Date of Visit

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Subject number
    Description

    Subject number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0008972 (Clinical Research)
    Date of subject completion or withdrawal
    Description

    Study End Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    Was the subject withdrawn from the study?
    Description

    Patient withdrawn from trial

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    If withdrawn from the study, please complete the primary reason:
    Description

    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.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    If investigator discretion, please specify:
    Description

    Clinical Investigators Judgment, specify

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2348235 (Specification)
    UMLS CUI [1,2]
    C0008961 (Clinical Investigators)
    UMLS CUI [1,3]
    C0022423 (Judgment)
    SNOMED
    61254005
    Will the subject enter the extension study?
    Description

    Study subject participation status, extension study

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0231448 (Extension)
    SNOMED
    255536004
    LOINC
    LP34039-5
    UMLS CUI [1,2]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,3]
    C2348568 (Study Subject Participation Status)
    Case book ready for signature
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1706256 (Clinical Study Case)
    UMLS CUI [1,2]
    C1519316 (Signature)
    LOINC
    LP248948-4
    Office use 1
    Description

    hidden

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0442603 (Office)
    SNOMED
    257649000
    Office use 2
    Description

    hidden

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0442603 (Office)
    SNOMED
    257649000
    Death
    Description

    Death

    Alias
    UMLS CUI-1
    C0011065 (Cessation of life)
    SNOMED
    419620001
    Is the subject alive?
    Description

    Alive

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2584946 (Alive (finding))
    SNOMED
    438949009
    LOINC
    LA4247-8
    If the subject is dead, enter date of death:
    Description

    date of death

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1148348 (Date of death)
    SNOMED
    399753006
    LOINC
    MTHU014693
    If the subject is dead, indicate the primary cause of death:
    Description

    cause of death

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0007465 (Cause of Death)
    SNOMED
    16100001
    LOINC
    LA10595-9
    If other cause of death, please specify
    Description

    other cause of death, to specify

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0007465 (Cause of Death)
    SNOMED
    16100001
    LOINC
    LA10595-9
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,3]
    C1521902 (To specify)
    Pregnancy information (Preg)
    Description

    Pregnancy information (Preg)

    Alias
    UMLS CUI-1
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI-2
    C1533716 (Information)
    Did the subject become pregnant during the study?
    Description

    If Yes, complete the paper Pregnancy Notification form.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3828490 (Pregnant During the Study)
    Pregnancy Information (Preg M)
    Description

    Pregnancy Information (Preg M)

    Alias
    UMLS CUI-1
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI-2
    C1533716 (Information)
    UMLS CUI-3
    C0086582 (Males)
    SNOMED
    10052007
    Did a female partner of the male subject become pregnant during the study?
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0919624 (Pregnancy of partner)
    UMLS CUI [1,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [1,3]
    C0008972 (Clinical Research)
    Retour au début de la page

    Similar models

    End of Study

    1 Formulaires
    1. StudyEvent: ODM
      1. End of Study
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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)
    Retour au début de la page 

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