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ID

37721

Description

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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Versions (1)
  1. 8/20/19 8/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 20, 2019

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

    English

    Study Conclusion

    1 forms  
    1. StudyEvent: ODM
      1. Study Conclusion
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Center number
    Description

    Study Coordinating Center, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2825181
    UMLS CUI [1,2]
    C1300638
    Patient Number
    Description

    Patient number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Description

    Person Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Study Conclusion
    Description

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C1707478
    Did the patient complete the study as planned?
    Description

    Clinical Trials, Complete

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C0205197
    If 'No', mark the Primary cause of withdrawal.
    Description

    Clinical Trials, Withdraw, Reason and justification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    Other - specify
    Description

    Clinical Trials, Withdraw, Reason and justification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    Comment on the reason for withdrawal
    Description

    Clinical Trials, Withdraw, Reason and justification, Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    UMLS CUI [1,4]
    C0947611
    Date of Final Study Evaluation
    Description

    Clinical Trials, Evaluation, Final, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C3853528
    UMLS CUI [1,4]
    C0011008
    Investigator's Signature
    Description

    Investigator's Signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's Signature
    Description

    Investigator Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Description

    Investigator Signature, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Study Conclusion

    1 forms
    1. StudyEvent: ODM
      1. Study Conclusion
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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