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29867

Descrizione

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

collegamento

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

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versioni (1)
  1. 24/04/18 24/04/18 - Halim Ugurlu
Titolare del copyright

GSK

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24 aprile 2018

DOI

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Licenza

Creative Commons BY-NC 3.0
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    GSK Study ID 104864-201-Pre-Next Course (Course 02)

    Inglese

    Pre-Next Course

    1 moduli  
    1. StudyEvent: ODM
      1. Pre-Next Course
    Identification Numbers
    Descrizione

    Identification Numbers

    Alias
    UMLS CUI-1
    C1300638
    Center Number
    Descrizione

    Center Number

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Patient Number
    Descrizione

    Patient Number

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Descrizione

    Patient Initials

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2986440
    Visit Date
    Descrizione

    Visit Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303
    Serious Adverse Experiences
    Descrizione

    Serious Adverse Experiences

    Alias
    UMLS CUI-1
    C1519255
    Has the patient had any serious adverse experiences during this course?
    Descrizione

    If there have been any serious adverse experiences since the last visit, please record details in the Serious Adverse Experience section.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    12-Lead Electrocardiogram
    Descrizione

    12-Lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456
    Date Performed
    Descrizione

    Perform only if clinically indicated, or if this is the patient's last course

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0011008
    Result of 12-Lead ECG
    Descrizione

    Result

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0430456
    Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)
    Descrizione

    Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)

    Alias
    UMLS CUI-1
    C0013516
    UMLS CUI-3
    C0521317
    Was an Ejection Fraction obtained?
    Descrizione

    Ejection Fraction

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0232174
    If Yes for the obtained Ejection Fraction
    Descrizione

    If Yes for the obtained Ejection Fraction

    Alias
    UMLS CUI-1
    C2700378
    Date Performed
    Descrizione

    Date Performed

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013516
    UMLS CUI [2]
    C0521317
    LV Ejection Fraction (2-dimensional mode) (%)
    Descrizione

    LV Ejection Fraction (2-dimensional mode) (%)

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C0428772
    Which procedure was performed?
    Descrizione

    Which procedure was performed?

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0013516
    UMLS CUI [2]
    C0521317
    Result of Echocardiography/MUGA
    Descrizione

    Result of Echocardiography/MUGA

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0013516
    UMLS CUI [2]
    C0521317
    Chest X-Ray
    Descrizione

    Chest X-Ray

    Alias
    UMLS CUI-1
    C0039985
    Date Performed
    Descrizione

    Date Performed

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0039985
    Result of Chest X-Ray
    Descrizione

    Result of Chest X-Ray

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0039985
    Supportive Therapy (Including Erythropoietin)
    Descrizione

    Supportive Therapy (Including Erythropoietin)

    Alias
    UMLS CUI-1
    C1879316
    UMLS CUI-2
    C0014822
    UMLS CUI-3
    C0344211
    UMLS CUI-4
    C1707479
    Has the patient received any transfusions during this course?
    Descrizione

    Supportive Therapy (Including Erythropoietin)

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0344211
    UMLS CUI [1,2]
    C1707479
    If Yes to Supportive Therapy (Including Erythropoietin)
    Descrizione

    If Yes to Supportive Therapy (Including Erythropoietin)

    Alias
    UMLS CUI-1
    C1879316
    UMLS CUI-2
    C0014822
    UMLS CUI-3
    C0344211
    UMLS CUI-4
    C1707479
    Specify the type of transfusions
    Descrizione

    Type of transfusions

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1879316
    UMLS CUI [1,2]
    C0332307
    Transfusions (Number of Units)
    Descrizione

    Transfusions (Number of Units)

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1879316
    UMLS CUI [1,2]
    C0237753
    Erythropoietin Dose
    Descrizione

    Erythropoietin Dose

    Tipo di dati

    float

    Unità di misura
    • units/kg
    Alias
    UMLS CUI [1,1]
    C0014822
    UMLS CUI [1,2]
    C3174092
    units/kg
    Date of transfusion
    Descrizione

    Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1879316
    Supportive Anti-Infective Therapy
    Descrizione

    Supportive Anti-Infective Therapy

    Alias
    UMLS CUI-1
    C1141958
    UMLS CUI-2
    C0344211
    UMLS CUI-3
    C1707479
    Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) during this course?
    Descrizione

    Supportive Anti-Infective Therapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1141958
    UMLS CUI [1,2]
    C0344211
    UMLS CUI [1,3]
    C1707479
    If Yes to Supportive Anti-Infective Therapy
    Descrizione

    If Yes to Supportive Anti-Infective Therapy

    Alias
    UMLS CUI-1
    C1141958
    UMLS CUI-2
    C0344211
    UMLS CUI-3
    C1707479
    Drug name (Trade Name Preferred)
    Descrizione

    Drug name

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2360065
    Total Daily Dose (e.g. 500mg)
    Descrizione

    Total Daily Dose

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348070
    Route
    Descrizione

    For Route, see general instructions for acceptable abbreviations.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0013153
    Medical Condition
    Descrizione

    Where appropriate, medical conditions should be recorded in the Ongoing Medical Conditions Associated with MDS or AML section, utilizing the same terminology.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C3843040
    Other
    Descrizione

    Record PM for anti-infectives administered prophylactically, EM for anti-infectives used for symptomatic treatment, and TX for anti-infectives administered for a confirmed infection in the column provided.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1141958
    Start Date (be as precise as possible)
    Descrizione

    Start Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C3174092
    End Date
    Descrizione

    End Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C3174092
    If Continuing to Medication
    Descrizione

    If Continuing to Medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    Concominant Medication
    Descrizione

    Concominant Medication

    Alias
    UMLS CUI-1
    C2347852
    Concominant Medication
    Descrizione

    Record all concomitant medication taken during this course. Record PM for prophylactic treatment with Medical Condition for prophylactically administered medications. If a medication was marked 'Continuing' at the initial visit, it must be recorded below. Where appropriate, medical conditions should be recorded on the Adverse Experience Form, utilizing the same terminology.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    If Yes to Concominant Medication
    Descrizione

    If Yes to Concominant Medication

    Alias
    UMLS CUI-1
    C2347852
    Drug name (Trade name Preferred)
    Descrizione

    Drug name

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2360065
    UMLS CUI [1,2]
    C2826257
    UMLS CUI [1,3]
    C2347852
    Total Daily Dose (e.g. 500mg)
    Descrizione

    Total Daily Dose

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348070
    Route
    Descrizione

    Route

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C2826257
    UMLS CUI [1,3]
    C2347852
    Medical Condition
    Descrizione

    Where appropriate, medical conditions should be recorded in the Significant Medical/Surgical History and Physical Examination section, utilizing the same terminology. Prior chemotherapy, biological, and immunotherapy should be recorded on pages 4 and 5. Record PM for prophylactic treatment with the Medical Condition for prophylactically administered medications.

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C3843040
    Start Date (be as precise as possible)
    Descrizione

    Start Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C2826257
    UMLS CUI [1,3]
    C2347852
    End Date
    Descrizione

    End Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C2826257
    UMLS CUI [1,3]
    C2347852
    If Continung to Medication
    Descrizione

    If Continung to Medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
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    Similar models

    Pre-Next Course

    1 moduli
    1. StudyEvent: ODM
      1. Pre-Next Course
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Identification Numbers
    C1300638 (UMLS CUI-1)
    Center Number
    Item
    Center Number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Serious Adverse Experiences
    C1519255 (UMLS CUI-1)
    Serious Adverse Experience
    Item
    Has the patient had any serious adverse experiences during this course?
    boolean
    C1519255 (UMLS CUI [1])
    Item Group
    12-Lead Electrocardiogram
    C0430456 (UMLS CUI-1)
    Date Performed
    Item
    Date Performed
    date
    C0013798 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Result of 12-Lead ECG
    text
    C1274040 (UMLS CUI [1,1])
    C0430456 (UMLS CUI [1,2])
    Result
    Code List
    Result of 12-Lead ECG
    CL Item
    No significant worsening since screening (2)
    CL Item
    Worsening since screening -> Please record in the Adverse Experience section (3)
    Item Group
    Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)
    C0013516 (UMLS CUI-1)
    C0521317 (UMLS CUI-3)
    Ejection Fraction
    Item
    Was an Ejection Fraction obtained?
    boolean
    C0232174 (UMLS CUI [1])
    Item Group
    If Yes for the obtained Ejection Fraction
    C2700378 (UMLS CUI-1)
    Date Performed
    Item
    Date Performed
    date
    C0011008 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    C0521317 (UMLS CUI [2])
    LV Ejection Fraction (2-dimensional mode) (%)
    Item
    LV Ejection Fraction (2-dimensional mode) (%)
    float
    C0428772 (UMLS CUI [1])
    Item
    Which procedure was performed?
    text
    C0013516 (UMLS CUI [1])
    C0521317 (UMLS CUI [2])
    Which procedure was performed?
    Code List
    Which procedure was performed?
    CL Item
    Echocardiogram (1)
    CL Item
    MUGA (2)
    Item
    Result of Echocardiography/MUGA
    text
    C1274040 (UMLS CUI [1,1])
    C0013516 (UMLS CUI [1,2])
    C0521317 (UMLS CUI [2])
    Result of Echocardiography/MUGA
    Code List
    Result of Echocardiography/MUGA
    CL Item
    No significant worsening since screening (2)
    CL Item
    Worsening since screening -> Please record in the Adverse Experience section (3)
    Item Group
    Chest X-Ray
    C0039985 (UMLS CUI-1)
    Date Performed
    Item
    Date Performed
    date
    C0011008 (UMLS CUI [1,1])
    C0039985 (UMLS CUI [1,2])
    Item
    Result of Chest X-Ray
    text
    C1274040 (UMLS CUI [1,1])
    C0039985 (UMLS CUI [1,2])
    Result of Chest X-Ray
    Code List
    Result of Chest X-Ray
    CL Item
    No significant worsening since screening (2)
    CL Item
    Worsening since screening -> Please record in the Adverse Experience section (3)
    Item Group
    Supportive Therapy (Including Erythropoietin)
    C1879316 (UMLS CUI-1)
    C0014822 (UMLS CUI-2)
    C0344211 (UMLS CUI-3)
    C1707479 (UMLS CUI-4)
    Supportive Therapy (Including Erythropoietin)
    Item
    Has the patient received any transfusions during this course?
    boolean
    C0344211 (UMLS CUI [1,1])
    C1707479 (UMLS CUI [1,2])
    Item Group
    If Yes to Supportive Therapy (Including Erythropoietin)
    C1879316 (UMLS CUI-1)
    C0014822 (UMLS CUI-2)
    C0344211 (UMLS CUI-3)
    C1707479 (UMLS CUI-4)
    Type of transfusions
    Item
    Specify the type of transfusions
    text
    C1879316 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Transfusions (Number of Units)
    Item
    Transfusions (Number of Units)
    text
    C1879316 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Erythropoietin Dose
    Item
    Erythropoietin Dose
    float
    C0014822 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    Date
    Item
    Date of transfusion
    date
    C0011008 (UMLS CUI [1,1])
    C1879316 (UMLS CUI [1,2])
    Item Group
    Supportive Anti-Infective Therapy
    C1141958 (UMLS CUI-1)
    C0344211 (UMLS CUI-2)
    C1707479 (UMLS CUI-3)
    Supportive Anti-Infective Therapy
    Item
    Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) during this course?
    boolean
    C1141958 (UMLS CUI [1,1])
    C0344211 (UMLS CUI [1,2])
    C1707479 (UMLS CUI [1,3])
    Item Group
    If Yes to Supportive Anti-Infective Therapy
    C1141958 (UMLS CUI-1)
    C0344211 (UMLS CUI-2)
    C1707479 (UMLS CUI-3)
    Drug name
    Item
    Drug name (Trade Name Preferred)
    text
    C2360065 (UMLS CUI [1])
    Total Daily Dose
    Item
    Total Daily Dose (e.g. 500mg)
    text
    C2348070 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Medical Condition
    Item
    Medical Condition
    text
    C3843040 (UMLS CUI [1])
    Item
    Other
    text
    C1141958 (UMLS CUI [1])
    Other
    Code List
    Other
    CL Item
    anti-infectives administered prophylactically (PM)
    CL Item
    anti-infectives used for symptomatic treatment (EM)
    CL Item
    anti-infectives administered for a confirmed infection in the column provided (TX)
    Start Date
    Item
    Start Date (be as precise as possible)
    date
    C0808070 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    If Continuing to Medication
    Item
    If Continuing to Medication
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Item Group
    Concominant Medication
    C2347852 (UMLS CUI-1)
    Concominant Medication
    Item
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    If Yes to Concominant Medication
    C2347852 (UMLS CUI-1)
    Drug name
    Item
    Drug name (Trade name Preferred)
    text
    C2360065 (UMLS CUI [1,1])
    C2826257 (UMLS CUI [1,2])
    C2347852 (UMLS CUI [1,3])
    Total Daily Dose
    Item
    Total Daily Dose (e.g. 500mg)
    text
    C2348070 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C2826257 (UMLS CUI [1,2])
    C2347852 (UMLS CUI [1,3])
    Medical Condition
    Item
    Medical Condition
    text
    C3843040 (UMLS CUI [1])
    Start Date
    Item
    Start Date (be as precise as possible)
    date
    C0808070 (UMLS CUI [1,1])
    C2826257 (UMLS CUI [1,2])
    C2347852 (UMLS CUI [1,3])
    End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C2826257 (UMLS CUI [1,2])
    C2347852 (UMLS CUI [1,3])
    If Continung to Medication
    Item
    If Continung to Medication
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
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