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ID

37123

Beschreibung

Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

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Versionen (2)
  1. 03.07.19 03.07.19 -
  2. 03.07.19 03.07.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

3. Juli 2019

DOI

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Creative Commons BY-NC 3.0
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    Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502

    Englisch

    Concomitant Medication

    1 Formulare  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Center Number
    Beschreibung

    Institution name, Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Patient Number
    Beschreibung

    Patient number

    Datentyp

    integer

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

    Person Initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Concomitant Medication
    Beschreibung

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Drug Name (Trade Name Preferred)
    Beschreibung

    Concomitant Agent, Medication name

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Unit Dose
    Beschreibung

    Concomitant Agent, Dosage, Unit

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C0439148 (Unit)
    SNOMED
    767525000
    Frequency
    Beschreibung

    Concomitant Agent, Frequencies

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0439603 (Frequencies (time pattern))
    SNOMED
    272123002
    LOINC
    LP130485-8
    Route
    Beschreibung

    Concomitant Agent, Drug Administration Routes

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
    Beschreibung

    Concomitant Agent, Disease

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Start Date
    Beschreibung

    Concomitant Medication Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    End Date
    Beschreibung

    Concomitant Medication End Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826744 (Concomitant Medication End Date)
    If Continuing mark box
    Beschreibung

    Concomitant Agent, Continuous

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Concomitant Medication

    1 Formulare
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Institution name, Identifier
    Item
    Center Number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (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
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant Agent, Medication name
    Item
    Drug Name (Trade Name Preferred)
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Agent, Dosage, Unit
    Item
    Unit Dose
    text
    C2347852 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0439148 (UMLS CUI [1,3])
    Concomitant Agent, Frequencies
    Item
    Frequency
    text
    C2347852 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Concomitant Agent, Drug Administration Routes
    Item
    Route
    text
    C2347852 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Concomitant Agent, Disease
    Item
    Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
    text
    C2347852 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Concomitant Medication Start Date
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    End Date
    date
    C2826744 (UMLS CUI [1])
    Concomitant Agent, Continuous
    Item
    If Continuing mark box
    boolean
    C2347852 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

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