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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

Nyckelord

Versioner (1)
  1. 2018-04-24 2018-04-24 - Halim Ugurlu
Rättsinnehavare

GSK

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24 april 2018

DOI

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Creative Commons BY-NC 3.0
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    GSK Study ID 104864-201

    Engelsk

    Screening

    1 Formulär  
    1. StudyEvent: ODM
      1. Screening
    Identification Numbers
    Beskrivning

    Identification Numbers

    Alias
    UMLS CUI-1
    C1300638
    Center Number
    Beskrivning

    Center Number

    Datatyp

    text

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

    Patient Number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Beskrivning

    Patient Initials

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2986440
    Visit Date
    Beskrivning

    Visit Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Demography
    Beskrivning

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of Birth
    Beskrivning

    Date of Birth

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Beskrivning

    Gender

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Beskrivning

    Race

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0034510
    Vital Signs
    Beskrivning

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Height (cm)
    Beskrivning

    Height (cm)

    Datatyp

    float

    Måttenheter
    • cm
    Alias
    UMLS CUI [1]
    C0489786
    cm
    Height (inch)
    Beskrivning

    Height (inch)

    Datatyp

    float

    Måttenheter
    • inch
    Alias
    UMLS CUI [1]
    C0489786
    inch
    Temperature localization
    Beskrivning

    Temperature

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0039476
    UMLS CUI [1,2]
    C0475264
    Temperature Grad
    Beskrivning

    Temperature

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0039476
    Temperature C/F
    Beskrivning

    Temperature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0039476
    Sitting Blood Pressure, Systolic-mmHg, After 5 Minutes Sitting
    Beskrivning

    Sitting Blood Pressure

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0580946
    Sitting Blood Pressure, Diastolic-mmHg, After 5 Minutes Sitting
    Beskrivning

    Sitting Blood Pressure, Diastolic-mmHg, After 5 Minutes Sitting

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0580946
    Pulse (beats/min), After 5 Minutes Sitting
    Beskrivning

    Pulse

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0232117
    12-Lead Electrocardiogram
    Beskrivning

    12-Lead Electrocardiogram

    Alias
    UMLS CUI-1
    C0430456
    Date Performed
    Beskrivning

    Date Performed

    Datatyp

    date

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

    Result

    Datatyp

    text

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

    Echocardiogram or Multiple Gated Acquisition Scanning (MUGA)

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

    Ejection Fraction

    Datatyp

    boolean

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

    If Yes for the obtained Ejection Fraction

    Alias
    UMLS CUI-1
    C2700378
    Date Performed
    Beskrivning

    Date Performed

    Datatyp

    date

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

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

    Datatyp

    float

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

    Which procedure was performed?

    Datatyp

    text

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

    Result of Echocardiography/MUGA

    Datatyp

    text

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

    Chest X-Ray

    Alias
    UMLS CUI-1
    C0039985
    Date Performed
    Beskrivning

    Date Performed

    Datatyp

    date

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

    Result of Chest X-Ray

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0039985
    History of Myelodysplastic Syndrome / Acute Myelogenous Leukemia
    Beskrivning

    History of Myelodysplastic Syndrome / Acute Myelogenous Leukemia

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0085669
    UMLS CUI-3
    C3463824
    Date of firts diagnosis of MDS
    Beskrivning

    Date of firts diagnosis of MDS

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C3463824
    UMLS CUI [1,2]
    C2316983
    Date of diagnosis of AML (if applicable)
    Beskrivning

    Date of diagnosis of AML

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C0023467
    Variant (choose only one)
    Beskrivning

    Variant

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0205419
    Previous Chemotherapy for MDS or AML
    Beskrivning

    Previous Chemotherapy for MDS or AML

    Alias
    UMLS CUI-1
    C1514463
    UMLS CUI-2
    C0023467
    UMLS CUI-3
    C3463824
    Has the patient had any chemotherapy for MDS or AML?
    Beskrivning

    Previous Chemotherapy for MDS or AML

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0023467
    UMLS CUI [1,3]
    C3463824
    If Yes to Previous Chemotherapy for MDS or AML
    Beskrivning

    If Yes to Previous Chemotherapy for MDS or AML

    Alias
    UMLS CUI-1
    C1514463
    UMLS CUI-2
    C0023467
    UMLS CUI-3
    C3463824
    First Line Regimen
    Beskrivning

    First Line Regimen

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0040808
    UMLS CUI [1,2]
    C0750480
    Please specify the Regimen Number for each component of the regimen.
    Beskrivning

    Regimen Number

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0040808
    UMLS CUI [1,2]
    C0237753
    Cumulative Dose (units)
    Beskrivning

    Cumulative Dose

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2986497
    Start Date
    Beskrivning

    Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0040808
    End Date
    Beskrivning

    End Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0040808
    Best Response Code
    Beskrivning

    Best Response Code

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2986560
    If not PD, provide duration of response (weeks)
    Beskrivning

    If not PD, provide duration of response (weeks)

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0237585
    Previous Biologic Therapy and/or Immunotherapy for MDS or AML
    Beskrivning

    Previous Biologic Therapy and/or Immunotherapy for MDS or AML

    Alias
    UMLS CUI-1
    C1514463
    UMLS CUI-2
    C0005527
    UMLS CUI-3
    C0278947
    UMLS CUI-4
    C0023467
    Has the patient had any biologic therapy and/or immunotherapy for MDS or AML?
    Beskrivning

    Previous Biologic Therapy and/or Immunotherapy for MDS or AML

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0005527
    UMLS CUI [1,3]
    C0278947
    UMLS CUI [1,4]
    C0023467
    If Yes to Previous Biologic Therapy and/or Immunotherapy for MDS or AML
    Beskrivning

    If Yes to Previous Biologic Therapy and/or Immunotherapy for MDS or AML

    Alias
    UMLS CUI-1
    C1514463
    UMLS CUI-2
    C0005527
    UMLS CUI-3
    C0278947
    UMLS CUI-4
    C0023467
    Regimen
    Beskrivning

    Regimen

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0237125
    Therapy No
    Beskrivning

    Therapy No

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0750480
    Cumulative Dose (units)
    Beskrivning

    Cumulative Dose

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2986497
    Start Date
    Beskrivning

    Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0040808
    End Date
    Beskrivning

    End Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0040808
    Best Response Code
    Beskrivning

    Best Response Code

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2986560
    UMLS CUI [1,2]
    C0805701
    If not PD, provide duration of response (weeks)
    Beskrivning

    If not PD, provide duration of response (weeks)

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0237585
    Toxicities Related to Previous Therapy for MDS or AML
    Beskrivning

    Toxicities Related to Previous Therapy for MDS or AML

    Alias
    UMLS CUI-1
    C0023467
    UMLS CUI-2
    C3463824
    UMLS CUI-3
    C2114510
    UMLS CUI-4
    C0439849
    UMLS CUI-5
    C0600688
    Does the patient have any other residual toxicities related to previous therapy for MDS or AML?
    Beskrivning

    Toxicities Related to Previous Therapy for MDS or AML

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C3463824
    UMLS CUI [1,3]
    C2114510
    UMLS CUI [1,4]
    C0439849
    UMLS CUI [1,5]
    C0600688
    If Yes to Toxicities Related to Previous Therapy for MDS or AML
    Beskrivning

    If Yes to Toxicities Related to Previous Therapy for MDS or AML

    Alias
    UMLS CUI-1
    C0023467
    UMLS CUI-2
    C3463824
    UMLS CUI-3
    C2114510
    UMLS CUI-4
    C0439849
    UMLS CUI-5
    C0600688
    Toxicity
    Beskrivning

    Toxicity

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0600688
    UMLS CUI [1,2]
    C2114510
    UMLS CUI [1,3]
    C0439849
    NCI Toxicity Grade
    Beskrivning

    NCI Common Toxicity Grade

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826262
    Previous Therapy
    Beskrivning

    Previous Therapy

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2114510
    Prior Transfusion Therapy (Including Erythropoietin)
    Beskrivning

    Prior Transfusion Therapy (Including Erythropoietin)

    Alias
    UMLS CUI-1
    C1879316
    UMLS CUI-2
    C1514463
    UMLS CUI-3
    C0014822
    Has the patient received any transfusion during the 4 weeks prior to this study?
    Beskrivning

    Record the medical condition in the Ongoing Medical Conditions Associated with MDS or AML section

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1879316
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [1,3]
    C0014822
    If Yes to Prior Transfusion Therapy (Including Erythropoietin)
    Beskrivning

    If Yes to Prior Transfusion Therapy (Including Erythropoietin)

    Alias
    UMLS CUI-1
    C1879316
    UMLS CUI-2
    C1514463
    UMLS CUI-3
    C0014822
    Specify the type of transfusions
    Beskrivning

    Type of transfusions

    Datatyp

    text

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

    Transfusions (Number of Units)

    Datatyp

    text

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

    Erythropoietin Dose

    Datatyp

    float

    Måttenheter
    • units/kg
    Alias
    UMLS CUI [1,1]
    C0014822
    UMLS CUI [1,2]
    C3174092
    units/kg
    Date of transfusion
    Beskrivning

    Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1879316
    Prior Anti-Infective Therapy
    Beskrivning

    Prior Anti-Infective Therapy

    Alias
    UMLS CUI-1
    C1141958
    UMLS CUI-2
    C1514463
    Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) during the 4 weeks prior to entering this study?
    Beskrivning

    Prior Anti-Infective Therapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1141958
    UMLS CUI [1,2]
    C1514463
    If Yes to Prior Anti-Infective Therapy
    Beskrivning

    If Yes to Prior Anti-Infective Therapy

    Alias
    UMLS CUI-1
    C1141958
    UMLS CUI-2
    C1514463
    Drug name (Trade Name Preferred)
    Beskrivning

    Drug name

    Datatyp

    text

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

    Total Daily Dose

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348070
    Route
    Beskrivning

    For Route, see general instructions for acceptable abbreviations.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0013153
    Medical Condition
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3843040
    Other
    Beskrivning

    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.

    Datatyp

    text

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

    Start Date

    Datatyp

    date

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

    End Date

    Datatyp

    date

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

    If Continuing to Medication

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    Prior and Concominant Medication
    Beskrivning

    Prior and Concominant Medication

    Alias
    UMLS CUI-1
    C2826257
    UMLS CUI-2
    C2347852
    Has the patient taken any medication in the past 30 days?
    Beskrivning

    Prior and Concominant Medication

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2826257
    UMLS CUI [1,2]
    C2347852
    If Yes to Prior and Concominant Medication
    Beskrivning

    If Yes to Prior and Concominant Medication

    Alias
    UMLS CUI-1
    C2826257
    UMLS CUI-2
    C2347852
    Drug name (Trade name Preferred)
    Beskrivning

    Drug name

    Datatyp

    text

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

    Total Daily Dose

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348070
    Route
    Beskrivning

    Route

    Datatyp

    text

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

    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.

    Datatyp

    text

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

    Start Date

    Datatyp

    date

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

    End Date

    Datatyp

    date

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

    If Continung to Medication

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    Ongoing Medical Conditions Associated with MDS or AML
    Beskrivning

    Ongoing Medical Conditions Associated with MDS or AML

    Alias
    UMLS CUI-1
    C0205476
    UMLS CUI-2
    C0348080
    UMLS CUI-3
    C0549178
    UMLS CUI-4
    C0023467
    UMLS CUI-5
    C3463824
    Does the Patient have any ongoing medical condition(s) that is associated with their MDS or AML?
    Beskrivning

    Ongoing Medical Conditions Associated with MDS or AML

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205476
    UMLS CUI [1,2]
    C0348080
    UMLS CUI [1,3]
    C0549178
    UMLS CUI [1,4]
    C0023467
    UMLS CUI [1,5]
    C3463824
    If Yes to Ongoing Medical Conditions Associated with MDS or AML
    Beskrivning

    If Yes to Ongoing Medical Conditions Associated with MDS or AML

    Alias
    UMLS CUI-1
    C0205476
    UMLS CUI-2
    C0348080
    UMLS CUI-3
    C0549178
    UMLS CUI-4
    C0023467
    UMLS CUI-5
    C3463824
    Condition
    Beskrivning

    Condition

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0205476
    UMLS CUI [1,2]
    C0348080
    UMLS CUI [1,3]
    C0549178
    UMLS CUI [1,4]
    C0023467
    UMLS CUI [1,5]
    C3463824
    NCI Toxicity Grade
    Beskrivning

    NCI Common Toxicity Grade

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826262
    Date of first diagnosis
    Beskrivning

    Date of first diagnosis

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2316983
    Prior Malignancies
    Beskrivning

    Prior Malignancies

    Alias
    UMLS CUI-1
    C0006826
    UMLS CUI-2
    C0332132
    Has the patient had any prior malignancies for which he/she has received prior treatment?
    Beskrivning

    Prior Malignancies

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0332132
    If Yes to Prior Malignancies
    Beskrivning

    If Yes to Prior Malignancies

    Alias
    UMLS CUI-1
    C0006826
    UMLS CUI-2
    C0332132
    Prior Malignancy
    Beskrivning

    Prior Malignancy

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0332132
    Prior Therapy
    Beskrivning

    Prior Therapy

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1514463
    Date of Diagnosis
    Beskrivning

    Date of Diagnosis

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2316983
    Date of Complete Remission
    Beskrivning

    Date of Complete Remission

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0677874
    Significant Medical/Surgery History and Physical Examination
    Beskrivning

    Significant Medical/Surgery History and Physical Examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition (do not include ongoing conditions associated with MDS or AML or toxicities due to prior therapy for MDS or AML; exclude prior malignancies)?
    Beskrivning

    Significant Medical/Surgery History and Physical Examination

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0031809
    If Yes to Significant Medical/Surgery History and Physical Examination
    Beskrivning

    If Yes to Significant Medical/Surgery History and Physical Examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    Diagnosis
    Beskrivning

    If 'Yes' please provide diagnosis below, listing no more than one diagnosis per line. All signs and symptoms referring to a single diagnosis must be recorded on the same line with the diagnosis. Signs and symptoms with out an associated diagnosis must be recorded on separate lines.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0031809
    NCI Grade
    Beskrivning

    NCI Grade

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3887242
    Year of Firts Diagnosis
    Beskrivning

    Year of Firts Diagnosis

    Datatyp

    partialDate

    Alias
    UMLS CUI [1,1]
    C0439234
    UMLS CUI [1,2]
    C0011900
    Past
    Beskrivning

    Past

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1444637
    UMLS CUI [1,2]
    C0262926
    Current/Active
    Beskrivning

    Current/Active

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2707252
    Tillbaka till toppen

    Similar models

    Screening

    1 Formulär
    1. StudyEvent: ODM
      1. Screening
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    Demography
    C0011298 (UMLS CUI-1)
    Date of Birth
    Item
    Date of Birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item
    Race
    text
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    White (C)
    CL Item
    Black (B)
    CL Item
    Oriental (E)
    CL Item
    Other, specify:............ (O)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Height (cm)
    Item
    Height (cm)
    float
    C0489786 (UMLS CUI [1])
    Height (inch)
    Item
    Height (inch)
    float
    C0489786 (UMLS CUI [1])
    Item
    Temperature localization
    text
    C0039476 (UMLS CUI [1,1])
    C0475264 (UMLS CUI [1,2])
    Temperature
    Code List
    Temperature localization
    CL Item
    Oral (O)
    CL Item
    Axillary (A)
    CL Item
    Rectal (R)
    CL Item
    Tympanic (T)
    Temperature
    Item
    Temperature Grad
    float
    C0039476 (UMLS CUI [1])
    Item
    Temperature C/F
    text
    C0039476 (UMLS CUI [1])
    Temperature
    Code List
    Temperature C/F
    CL Item
    Celcius (C)
    CL Item
    Fahrenheit (F)
    Sitting Blood Pressure
    Item
    Sitting Blood Pressure, Systolic-mmHg, After 5 Minutes Sitting
    integer
    C0580946 (UMLS CUI [1])
    Sitting Blood Pressure, Diastolic-mmHg, After 5 Minutes Sitting
    Item
    Sitting Blood Pressure, Diastolic-mmHg, After 5 Minutes Sitting
    integer
    C0580946 (UMLS CUI [1])
    Pulse
    Item
    Pulse (beats/min), After 5 Minutes Sitting
    integer
    C0232117 (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
    Normal/no clinically significant abnormality (1)
    CL Item
    Clinically significant abnormality (If 'Yes' please record details on the Significant Medical/ Surgical History and Physical Examination page.) (2)
    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) (procent)
    Item
    LV Ejection Fraction (2-dimensional mode) (procent)
    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
    Normal/no clinically significant abnormality (1)
    CL Item
    Clinically significant abnormality (If 'Yes' please record details on the Significant Medical/ Surgical History and Physical Examination page.)  (2)
    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
    Normal/no clinically significant abnormality (1)
    CL Item
    Clinically significant abnormality (If 'Yes' please record details on the Significant Medical/ Surgical History and Physical Examination page.)  (2)
    Item Group
    History of Myelodysplastic Syndrome / Acute Myelogenous Leukemia
    C0262926 (UMLS CUI-1)
    C0085669 (UMLS CUI-2)
    C3463824 (UMLS CUI-3)
    Date of firts diagnosis of MDS
    Item
    Date of firts diagnosis of MDS
    date
    C3463824 (UMLS CUI [1,1])
    C2316983 (UMLS CUI [1,2])
    Date of diagnosis of AML
    Item
    Date of diagnosis of AML (if applicable)
    date
    C2316983 (UMLS CUI [1,1])
    C0023467 (UMLS CUI [1,2])
    Item
    Variant (choose only one)
    text
    C0205419 (UMLS CUI [1])
    Variant
    Code List
    Variant (choose only one)
    CL Item
    INT-2 RAEB (1)
    CL Item
    High Risk RAEB (2)
    CL Item
    RAEB-t (3)
    CL Item
    AML (4)
    Item Group
    Previous Chemotherapy for MDS or AML
    C1514463 (UMLS CUI-1)
    C0023467 (UMLS CUI-2)
    C3463824 (UMLS CUI-3)
    Previous Chemotherapy for MDS or AML
    Item
    Has the patient had any chemotherapy for MDS or AML?
    boolean
    C1514463 (UMLS CUI [1,1])
    C0023467 (UMLS CUI [1,2])
    C3463824 (UMLS CUI [1,3])
    Item Group
    If Yes to Previous Chemotherapy for MDS or AML
    C1514463 (UMLS CUI-1)
    C0023467 (UMLS CUI-2)
    C3463824 (UMLS CUI-3)
    First Line Regimen
    Item
    First Line Regimen
    text
    C0040808 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Regimen Number
    Item
    Please specify the Regimen Number for each component of the regimen.
    text
    C0040808 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Cumulative Dose
    Item
    Cumulative Dose (units)
    text
    C2986497 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0040808 (UMLS CUI [1,2])
    End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C0040808 (UMLS CUI [1,2])
    Item
    Best Response Code
    text
    C2986560 (UMLS CUI [1])
    Best Response Code
    Code List
    Best Response Code
    CL Item
    Complete response (CR) (1)
    CL Item
    Partial response (PR) (2)
    CL Item
    Stable Disease (SD) (3)
    CL Item
    Progression (PD) (4)
    CL Item
    Hematologic Improvement (HI) (15)
    If not PD, provide duration of response (weeks)
    Item
    If not PD, provide duration of response (weeks)
    text
    C0237585 (UMLS CUI [1])
    Item Group
    Previous Biologic Therapy and/or Immunotherapy for MDS or AML
    C1514463 (UMLS CUI-1)
    C0005527 (UMLS CUI-2)
    C0278947 (UMLS CUI-3)
    C0023467 (UMLS CUI-4)
    Previous Biologic Therapy and/or Immunotherapy for MDS or AML
    Item
    Has the patient had any biologic therapy and/or immunotherapy for MDS or AML?
    boolean
    C1514463 (UMLS CUI [1,1])
    C0005527 (UMLS CUI [1,2])
    C0278947 (UMLS CUI [1,3])
    C0023467 (UMLS CUI [1,4])
    Item Group
    If Yes to Previous Biologic Therapy and/or Immunotherapy for MDS or AML
    C1514463 (UMLS CUI-1)
    C0005527 (UMLS CUI-2)
    C0278947 (UMLS CUI-3)
    C0023467 (UMLS CUI-4)
    Regimen
    Item
    Regimen
    text
    C0237125 (UMLS CUI [1])
    Item
    Therapy No
    text
    C0087111 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Therapy No
    Code List
    Therapy No
    CL Item
    Biologic (1)
    CL Item
    Immunotherapy (3)
    Cumulative Dose
    Item
    Cumulative Dose (units)
    text
    C2986497 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0040808 (UMLS CUI [1,2])
    End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C0040808 (UMLS CUI [1,2])
    Item
    Best Response Code
    text
    C2986560 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Best Response Code
    Code List
    Best Response Code
    CL Item
    Complete response (CR)  (1)
    CL Item
    Partial response (PR)  (2)
    CL Item
    Stable Disease (SD)  (3)
    CL Item
    Progression (PD)  (4)
    CL Item
    Hematologic Improvement (HI) (15)
    If not PD, provide duration of response (weeks)
    Item
    If not PD, provide duration of response (weeks)
    text
    C0237585 (UMLS CUI [1])
    Item Group
    Toxicities Related to Previous Therapy for MDS or AML
    C0023467 (UMLS CUI-1)
    C3463824 (UMLS CUI-2)
    C2114510 (UMLS CUI-3)
    C0439849 (UMLS CUI-4)
    C0600688 (UMLS CUI-5)
    Toxicities Related to Previous Therapy for MDS or AML
    Item
    Does the patient have any other residual toxicities related to previous therapy for MDS or AML?
    boolean
    C0023467 (UMLS CUI [1,1])
    C3463824 (UMLS CUI [1,2])
    C2114510 (UMLS CUI [1,3])
    C0439849 (UMLS CUI [1,4])
    C0600688 (UMLS CUI [1,5])
    Item Group
    If Yes to Toxicities Related to Previous Therapy for MDS or AML
    C0023467 (UMLS CUI-1)
    C3463824 (UMLS CUI-2)
    C2114510 (UMLS CUI-3)
    C0439849 (UMLS CUI-4)
    C0600688 (UMLS CUI-5)
    Toxicity
    Item
    Toxicity
    text
    C0600688 (UMLS CUI [1,1])
    C2114510 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    NCI Toxicity Grade
    Item
    NCI Toxicity Grade
    text
    C2826262 (UMLS CUI [1])
    Previous Therapy
    Item
    Previous Therapy
    text
    C2114510 (UMLS CUI [1])
    Item Group
    Prior Transfusion Therapy (Including Erythropoietin)
    C1879316 (UMLS CUI-1)
    C1514463 (UMLS CUI-2)
    C0014822 (UMLS CUI-3)
    Prior Transfusion Therapy (Including Erythropoietin)
    Item
    Has the patient received any transfusion during the 4 weeks prior to this study?
    boolean
    C1879316 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C0014822 (UMLS CUI [1,3])
    Item Group
    If Yes to Prior Transfusion Therapy (Including Erythropoietin)
    C1879316 (UMLS CUI-1)
    C1514463 (UMLS CUI-2)
    C0014822 (UMLS CUI-3)
    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
    Prior Anti-Infective Therapy
    C1141958 (UMLS CUI-1)
    C1514463 (UMLS CUI-2)
    Prior Anti-Infective Therapy
    Item
    Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) during the 4 weeks prior to entering this study?
    boolean
    C1141958 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    Item Group
    If Yes to Prior Anti-Infective Therapy
    C1141958 (UMLS CUI-1)
    C1514463 (UMLS CUI-2)
    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
    Prior and Concominant Medication
    C2826257 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Prior and Concominant Medication
    Item
    Has the patient taken any medication in the past 30 days?
    boolean
    C2826257 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Item Group
    If Yes to Prior and Concominant Medication
    C2826257 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    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])
    Item Group
    Ongoing Medical Conditions Associated with MDS or AML
    C0205476 (UMLS CUI-1)
    C0348080 (UMLS CUI-2)
    C0549178 (UMLS CUI-3)
    C0023467 (UMLS CUI-4)
    C3463824 (UMLS CUI-5)
    Ongoing Medical Conditions Associated with MDS or AML
    Item
    Does the Patient have any ongoing medical condition(s) that is associated with their MDS or AML?
    boolean
    C0205476 (UMLS CUI [1,1])
    C0348080 (UMLS CUI [1,2])
    C0549178 (UMLS CUI [1,3])
    C0023467 (UMLS CUI [1,4])
    C3463824 (UMLS CUI [1,5])
    Item Group
    If Yes to Ongoing Medical Conditions Associated with MDS or AML
    C0205476 (UMLS CUI-1)
    C0348080 (UMLS CUI-2)
    C0549178 (UMLS CUI-3)
    C0023467 (UMLS CUI-4)
    C3463824 (UMLS CUI-5)
    Condition
    Item
    Condition
    text
    C0205476 (UMLS CUI [1,1])
    C0348080 (UMLS CUI [1,2])
    C0549178 (UMLS CUI [1,3])
    C0023467 (UMLS CUI [1,4])
    C3463824 (UMLS CUI [1,5])
    NCI Common Toxicity Grade
    Item
    NCI Toxicity Grade
    text
    C2826262 (UMLS CUI [1])
    Date of first diagnosis
    Item
    Date of first diagnosis
    date
    C2316983 (UMLS CUI [1])
    Item Group
    Prior Malignancies
    C0006826 (UMLS CUI-1)
    C0332132 (UMLS CUI-2)
    Prior Malignancies
    Item
    Has the patient had any prior malignancies for which he/she has received prior treatment?
    boolean
    C0006826 (UMLS CUI [1,1])
    C0332132 (UMLS CUI [1,2])
    Item Group
    If Yes to Prior Malignancies
    C0006826 (UMLS CUI-1)
    C0332132 (UMLS CUI-2)
    Prior Malignancy
    Item
    Prior Malignancy
    text
    C0006826 (UMLS CUI [1,1])
    C0332132 (UMLS CUI [1,2])
    Prior Therapy
    Item
    Prior Therapy
    text
    C1514463 (UMLS CUI [1])
    Date of Diagnosis
    Item
    Date of Diagnosis
    date
    C2316983 (UMLS CUI [1])
    Date of Complete Remission
    Item
    Date of Complete Remission
    date
    C0011008 (UMLS CUI [1,1])
    C0677874 (UMLS CUI [1,2])
    Item Group
    Significant Medical/Surgery History and Physical Examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Significant Medical/Surgery History and Physical Examination
    Item
    Is the patient suffering from or has he/she ever suffered from any significant medical or surgical condition (do not include ongoing conditions associated with MDS or AML or toxicities due to prior therapy for MDS or AML; exclude prior malignancies)?
    boolean
    C0262926 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    Item Group
    If Yes to Significant Medical/Surgery History and Physical Examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Diagnosis
    Item
    Diagnosis
    text
    C0262926 (UMLS CUI [1,1])
    C0031809 (UMLS CUI [1,2])
    NCI Grade
    Item
    NCI Grade
    text
    C3887242 (UMLS CUI [1])
    Year of Firts Diagnosis
    Item
    Year of Firts Diagnosis
    partialDate
    C0439234 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Past
    Item
    Past
    boolean
    C1444637 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    Current/Active
    Item
    Current/Active
    boolean
    C2707252 (UMLS CUI [1])
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