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ID

37721

Descrizione

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

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  1. 20/08/19 20/08/19 -
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GlaxoSmithKline

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20 agosto 2019

DOI

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Licenza

Creative Commons BY-NC 3.0
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    Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

    Inglese

    Study Conclusion

    1 moduli  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Descrizione

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Center number
    Descrizione

    Study Coordinating Center, Identification number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C2825181 (Study Coordinating Center)
    UMLS CUI [1,2]
    C1300638 (Identification number)
    SNOMED
    396278008
    Patient Number
    Descrizione

    Patient number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1830427 (undefined)
    Patient Initials
    Descrizione

    Person Initials

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Study Conclusion
    Descrizione

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-2
    C1707478 (Conclusion)
    Did the patient complete the study as planned?
    Descrizione

    Clinical Trials, Complete

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    If 'No', mark the Primary cause of withdrawal.
    Descrizione

    Clinical Trials, Withdraw, Reason and justification

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Other - specify
    Descrizione

    Clinical Trials, Withdraw, Reason and justification

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Comment on the reason for withdrawal
    Descrizione

    Clinical Trials, Withdraw, Reason and justification, Comment

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,4]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Date of Final Study Evaluation
    Descrizione

    Clinical Trials, Evaluation, Final, Date in time

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    UMLS CUI [1,3]
    C3853528 (Final)
    LOINC
    LA16388-3
    UMLS CUI [1,4]
    C0011008 (Date in time)
    SNOMED
    410671006
    Investigator's Signature
    Descrizione

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576 (Investigator Signature)
    Investigator's Signature
    Descrizione

    Investigator Signature

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date
    Descrizione

    Investigator Signature, Date in time

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
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    Similar models

    Study Conclusion

    1 moduli
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Study Coordinating Center, Identification number
    Item
    Center number
    integer
    C2825181 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Patient number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Person Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Study Conclusion
    C0008976 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Clinical Trials, Complete
    Item
    Did the patient complete the study as planned?
    boolean
    C0008976 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    Item
    If 'No', mark the Primary cause of withdrawal.
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Clinical Trials, Withdraw, Reason and justification
    Code List
    If 'No', mark the Primary cause of withdrawal.
    CL Item
    Adverse Experience (1)
    CL Item
    Insufficient therapeutic effect (2)
    CL Item
    Protocol deviation (including non-compliance) (3)
    CL Item
    Lost to follow-up (4)
    CL Item
    Other - specify (5)
    Clinical Trials, Withdraw, Reason and justification
    Item
    Other - specify
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Clinical Trials, Withdraw, Reason and justification, Comment
    Item
    Comment on the reason for withdrawal
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    Clinical Trials, Evaluation, Final, Date in time
    Item
    Date of Final Study Evaluation
    date
    C0008976 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C3853528 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item Group
    Investigator's Signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature, Date in time
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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