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ID

37740

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. 8/21/19 8/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 21, 2019

DOI

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License

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

    English

    Patient Log

    1 forms  
    1. StudyEvent: ODM
      1. Patient Log
    Administrative Data
    Description

    Administrative Data

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

    Study Coordinating Center, Identification number

    Data type

    integer

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

    Patient Log

    Alias
    UMLS CUI-1
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI-2
    C2828389 (Exclusion)
    Investigator
    Description

    Patients, Exclusion, Investigator Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C2828389 (Exclusion)
    UMLS CUI [1,3]
    C2826892 (Investigator Name)
    Patient Initials
    Description

    Patients, Exclusion, Person Initials

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C2828389 (Exclusion)
    UMLS CUI [1,3]
    C2986440 (Person Initials)
    Interview Date
    Description

    Patients, Exclusion, patient interview, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C2828389 (Exclusion)
    UMLS CUI [1,3]
    C0683518 (patient interview)
    UMLS CUI [1,4]
    C0011008 (Date in time)
    SNOMED
    410671006
    Reason for Exclusion
    Description

    Patients, Exclusion, Reason and justification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C2828389 (Exclusion)
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
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    Similar models

    Patient Log

    1 forms
    1. StudyEvent: ODM
      1. Patient Log
    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])
    Item Group
    Patient Log
    C0030705 (UMLS CUI-1)
    C2828389 (UMLS CUI-2)
    Patients, Exclusion, Investigator Name
    Item
    Investigator
    text
    C0030705 (UMLS CUI [1,1])
    C2828389 (UMLS CUI [1,2])
    C2826892 (UMLS CUI [1,3])
    Patients, Exclusion, Person Initials
    Item
    Patient Initials
    text
    C0030705 (UMLS CUI [1,1])
    C2828389 (UMLS CUI [1,2])
    C2986440 (UMLS CUI [1,3])
    Patients, Exclusion, patient interview, Date in time
    Item
    Interview Date
    date
    C0030705 (UMLS CUI [1,1])
    C2828389 (UMLS CUI [1,2])
    C0683518 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Patients, Exclusion, Reason and justification
    Item
    Reason for Exclusion
    text
    C0030705 (UMLS CUI [1,1])
    C2828389 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
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