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ID

29865

Description

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

Link

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

Keywords

Versions (1)
  1. 4/24/18 4/24/18 - Halim Ugurlu
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GSK

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April 24, 2018

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Creative Commons BY-NC 3.0
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    GSK Study ID 104864-201-Medication (next Course)

    English

    Medication

    1 forms  
    1. StudyEvent: ODM
      1. Medication
    Identification Numbers
    Description

    Identification Numbers

    Alias
    UMLS CUI-1
    C1300638
    Center Number
    Description

    Center Number

    Data type

    text

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

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Topotecan and Ara-C Study Medication Record
    Description

    Topotecan and Ara-C Study Medication Record

    Alias
    UMLS CUI-1
    C2734539
    UMLS CUI-2
    C0008972
    UMLS CUI-3
    C0146224
    UMLS CUI-4
    C0733521
    Weight
    Description

    Record the patient's weight below, on Day 1 of infusion

    Data type

    text

    Alias
    UMLS CUI [1]
    C0005910
    Body Surface Area
    Description

    Record the patient's body surface area below, on Day 1 of infusion

    Data type

    float

    Measurement units
    • m^2
    Alias
    UMLS CUI [1]
    C0005902
    m^2
    Ideal Weight
    Description

    Ideal Weight

    Data type

    text

    Alias
    UMLS CUI [1]
    C0421272
    Ideal Weight Was Used
    Description

    Please mark the box below if the ideal weight was used to calculate body surface area.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0421272
    Topotecan Administration
    Description

    Topotecan Administration

    Alias
    UMLS CUI-1
    C3469597
    UMLS CUI-2
    C0146224
    Day
    Description

    Day

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439228
    Totally Daily Dose for this Infusion
    Description

    Totally Daily Dose for this Infusion

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1]
    C2348070
    mg
    Infusion start date
    Description

    Infusion start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [1,3]
    C0439659
    Infusion Start time
    Description

    Infusion Start time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0439659
    UMLS CUI [1,3]
    C0040223
    Infusion Stop date
    Description

    Infusion Stop date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0574032
    Infusion Stop time
    Description

    Infusion Stop time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [1,3]
    C0040223
    Ara-C Administration
    Description

    Ara-C Administration

    Alias
    UMLS CUI-1
    C0733521
    UMLS CUI-2
    C3469597
    Day
    Description

    Day

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439228
    Totally Daily Dose for this Infusion
    Description

    Totally Daily Dose for this Infusion

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1]
    C2348070
    mg
    Infusion start date
    Description

    Infusion start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [1,3]
    C0439659
    Infusion Start time
    Description

    Infusion Start time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0439659
    UMLS CUI [1,3]
    C0040223
    Infusion Stop date
    Description

    Infusion Stop date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0574032
    Infusion Stop time
    Description

    Infusion Stop time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [1,3]
    C0040223
    Idarubicin and Ara-C Study Medication Record
    Description

    Idarubicin and Ara-C Study Medication Record

    Alias
    UMLS CUI-1
    C2734539
    UMLS CUI-2
    C0008972
    UMLS CUI-3
    C0020789
    UMLS CUI-4
    C0020789
    Weight
    Description

    Record the patient's weight below, on Day 1 of infusion

    Data type

    text

    Alias
    UMLS CUI [1]
    C0005910
    Body Surface Area
    Description

    Record the patient's body surface area below, on Day 1 of infusion

    Data type

    float

    Measurement units
    • m^2
    Alias
    UMLS CUI [1]
    C0005902
    m^2
    Ideal Weight
    Description

    Ideal Weight

    Data type

    text

    Alias
    UMLS CUI [1]
    C0421272
    Ideal Weight Was Used
    Description

    Please mark the box below if the ideal weight was used to calculate body surface area.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0421272
    Idarubicin Administration
    Description

    Idarubicin Administration

    Alias
    UMLS CUI-1
    C0013153
    UMLS CUI-2
    C0020789
    Day
    Description

    Day

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439228
    Totally Daily Dose for this Infusion
    Description

    Totally Daily Dose for this Infusion

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1]
    C2348070
    mg
    Infusion start date
    Description

    Infusion start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [1,3]
    C0439659
    Infusion Start time
    Description

    Infusion Start time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0439659
    UMLS CUI [1,3]
    C0040223
    Infusion Stop date
    Description

    Infusion Stop date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0574032
    Infusion Stop time
    Description

    Infusion Stop time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [1,3]
    C0040223
    Ara-C Administration
    Description

    Ara-C Administration

    Alias
    UMLS CUI-1
    C0733521
    UMLS CUI-2
    C3469597
    Day
    Description

    Day

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439228
    Totally Daily Dose for this Infusion
    Description

    Totally Daily Dose for this Infusion

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1]
    C2348070
    mg
    Infusion start date
    Description

    Infusion start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [1,3]
    C0439659
    Infusion Start time
    Description

    Infusion Start time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0439659
    UMLS CUI [1,3]
    C0040223
    Infusion Stop date
    Description

    Infusion Stop date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0574032
    Infusion Stop time
    Description

    Infusion Stop time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [1,3]
    C0040223
    Dose Reduction
    Description

    Dose Reduction

    Alias
    UMLS CUI-1
    C0178602
    UMLS CUI-2
    C0547047
    Was the dose reduced compared to previous course?
    Description

    For any patient who does not have CR at course 1 and who has grade 3 or 4 non-hematologic toxicity (excluding toxicities of nausea, vomiting or alopecia) may receive a 25% dose reduction at course 2 only. Refer to protocol Section 6.2.3

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0547047
    If Yes to Dose Reduction, reason, (if applicable, mark more than one box below)
    Description

    If Yes to Dose Reduction

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0547047
    Retreatment Interval
    Description

    Retreatment Interval

    Alias
    UMLS CUI-1
    C0376495
    UMLS CUI-2
    C1272706
    Was the patient treated at 4 week (28 day) interval?
    Description

    Retreatment Interval

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0376495
    UMLS CUI [1,2]
    C1272706
    If 'No' please indicate the retreatment interval below
    Description

    If No to

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0376495
    UMLS CUI [1,2]
    C1272706
    UMLS CUI [1,3]
    C1518422
    Approved by
    Description

    Approved by

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C1708968
    Date of Approve
    Description

    Date of Approve

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    G-CSF Study Medication Record
    Description

    G-CSF Study Medication Record

    Alias
    UMLS CUI-1
    C2734539
    UMLS CUI-2
    C0008972
    UMLS CUI-3
    C0079459
    Day
    Description

    Day 14 to 28

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439228
    Dose
    Description

    Dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0079459
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0079459
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Vital Signs-TAG Regiment only
    Description

    Vital Signs-TAG Regiment only

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0146224
    UMLS CUI-3
    C0733521
    UMLS CUI-4
    C0079459
    UMLS CUI-5
    C0013227
    Day
    Description

    Day

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439228
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Scheduled Time
    Description

    Prior to infusion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C1301732
    Actual Time
    Description

    Actual Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0237400
    Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
    Description

    Sitting Blood Pressure (Systolic) After 5 Minutes Sitting

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    mmHg
    Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
    Description

    Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    mmHg
    Pulse After 5 Minutes Sitting
    Description

    Pulse After 5 Minutes Sitting

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0232117
    UMLS CUI [1,2]
    C0277814
    beats/min
    Vital Signs-IDAG Regiment only-Vital signs are to be performed on Days 1, 2, and 3 prior to idarubicin infusion and post ara-C infusion. On Days 4 and 5, vital signs are to be performed prior and post ara-C infusion
    Description

    Vital Signs-IDAG Regiment only-Vital signs are to be performed on Days 1, 2, and 3 prior to idarubicin infusion and post ara-C infusion. On Days 4 and 5, vital signs are to be performed prior and post ara-C infusion

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0020789
    UMLS CUI-3
    C0733521
    UMLS CUI-4
    C0079459
    UMLS CUI-5
    C0013227
    Day
    Description

    Day

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439228
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Scheduled Time
    Description

    Prior to infusion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C1301732
    Actual Time
    Description

    Actual Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0237400
    Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
    Description

    Sitting Blood Pressure (Systolic) After 5 Minutes Sitting

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    mmHg
    Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
    Description

    Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    mmHg
    Pulse After 5 Minutes Sitting
    Description

    Pulse After 5 Minutes Sitting

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0232117
    UMLS CUI [1,2]
    C0277814
    beats/min
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    Similar models

    Medication

    1 forms
    1. StudyEvent: ODM
      1. Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Topotecan and Ara-C Study Medication Record
    C2734539 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    C0146224 (UMLS CUI-3)
    C0733521 (UMLS CUI-4)
    Weight
    Item
    Weight
    text
    C0005910 (UMLS CUI [1])
    Body Surface Area
    Item
    Body Surface Area
    float
    C0005902 (UMLS CUI [1])
    Ideal Weight
    Item
    Ideal Weight
    text
    C0421272 (UMLS CUI [1])
    Ideal Weight Was Used
    Item
    Ideal Weight Was Used
    boolean
    C0421272 (UMLS CUI [1])
    Item Group
    Topotecan Administration
    C3469597 (UMLS CUI-1)
    C0146224 (UMLS CUI-2)
    Day
    Item
    Day
    text
    C0439228 (UMLS CUI [1])
    Totally Daily Dose for this Infusion
    Item
    Totally Daily Dose for this Infusion
    float
    C2348070 (UMLS CUI [1])
    Infusion start date
    Item
    Infusion start date
    date
    C0011008 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0439659 (UMLS CUI [1,3])
    Infusion Start time
    Item
    Infusion Start time
    time
    C0574032 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Infusion Stop date
    Item
    Infusion Stop date
    date
    C0806020 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    Infusion Stop time
    Item
    Infusion Stop time
    time
    C1522314 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item Group
    Ara-C Administration
    C0733521 (UMLS CUI-1)
    C3469597 (UMLS CUI-2)
    Day
    Item
    Day
    text
    C0439228 (UMLS CUI [1])
    Totally Daily Dose for this Infusion
    Item
    Totally Daily Dose for this Infusion
    float
    C2348070 (UMLS CUI [1])
    Infusion start date
    Item
    Infusion start date
    date
    C0011008 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0439659 (UMLS CUI [1,3])
    Infusion Start time
    Item
    Infusion Start time
    time
    C0574032 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Infusion Stop date
    Item
    Infusion Stop date
    date
    C0806020 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    Infusion Stop time
    Item
    Infusion Stop time
    time
    C1522314 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item Group
    Idarubicin and Ara-C Study Medication Record
    C2734539 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    C0020789 (UMLS CUI-3)
    C0020789 (UMLS CUI-4)
    Weight
    Item
    Weight
    text
    C0005910 (UMLS CUI [1])
    Body Surface Area
    Item
    Body Surface Area
    float
    C0005902 (UMLS CUI [1])
    Ideal Weight
    Item
    Ideal Weight
    text
    C0421272 (UMLS CUI [1])
    Ideal Weight Was Used
    Item
    Ideal Weight Was Used
    boolean
    C0421272 (UMLS CUI [1])
    Item Group
    Idarubicin Administration
    C0013153 (UMLS CUI-1)
    C0020789 (UMLS CUI-2)
    Day
    Item
    Day
    text
    C0439228 (UMLS CUI [1])
    Totally Daily Dose for this Infusion
    Item
    Totally Daily Dose for this Infusion
    float
    C2348070 (UMLS CUI [1])
    Infusion start date
    Item
    Infusion start date
    date
    C0011008 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0439659 (UMLS CUI [1,3])
    Infusion Start time
    Item
    Infusion Start time
    time
    C0574032 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Infusion Stop date
    Item
    Infusion Stop date
    date
    C0806020 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    Infusion Stop time
    Item
    Infusion Stop time
    time
    C1522314 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item Group
    Ara-C Administration
    C0733521 (UMLS CUI-1)
    C3469597 (UMLS CUI-2)
    Day
    Item
    Day
    text
    C0439228 (UMLS CUI [1])
    Totally Daily Dose for this Infusion
    Item
    Totally Daily Dose for this Infusion
    float
    C2348070 (UMLS CUI [1])
    Infusion start date
    Item
    Infusion start date
    date
    C0011008 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0439659 (UMLS CUI [1,3])
    Infusion Start time
    Item
    Infusion Start time
    time
    C0574032 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Infusion Stop date
    Item
    Infusion Stop date
    date
    C0806020 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    Infusion Stop time
    Item
    Infusion Stop time
    time
    C1522314 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item Group
    Dose Reduction
    C0178602 (UMLS CUI-1)
    C0547047 (UMLS CUI-2)
    Dose Reduction
    Item
    Was the dose reduced compared to previous course?
    boolean
    C0178602 (UMLS CUI [1,1])
    C0547047 (UMLS CUI [1,2])
    Item
    If Yes to Dose Reduction, reason, (if applicable, mark more than one box below)
    text
    C0178602 (UMLS CUI [1,1])
    C0547047 (UMLS CUI [1,2])
    If Yes to Dose Reduction
    Code List
    If Yes to Dose Reduction, reason, (if applicable, mark more than one box below)
    CL Item
    Grade 3 or 4 non-hematologic toxicity ->Record in the Adverse Experience section (2)
    CL Item
    Consolidation (3)
    CL Item
    Other, specify:...................... (4)
    Item Group
    Retreatment Interval
    C0376495 (UMLS CUI-1)
    C1272706 (UMLS CUI-2)
    Retreatment Interval
    Item
    Was the patient treated at 4 week (28 day) interval?
    boolean
    C0376495 (UMLS CUI [1,1])
    C1272706 (UMLS CUI [1,2])
    Item
    If 'No' please indicate the retreatment interval below
    text
    C0376495 (UMLS CUI [1,1])
    C1272706 (UMLS CUI [1,2])
    C1518422 (UMLS CUI [1,3])
    If No to " treated at 4 week (28 day) interval"
    Code List
    If 'No' please indicate the retreatment interval below
    CL Item
    29-35 days (4-5 week interval) (1)
    CL Item
    36-42 days (5-6 week interval) (2)
    CL Item
    Other (> 42 Days or > 6 weeks), specify:............................... Specify reason=.............................. (3)
    Approved by
    Item
    Approved by
    text
    C0027365 (UMLS CUI [1,1])
    C1708968 (UMLS CUI [1,2])
    Date of Approve
    Item
    Date of Approve
    date
    C0011008 (UMLS CUI [1])
    Item Group
    G-CSF Study Medication Record
    C2734539 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    C0079459 (UMLS CUI-3)
    Day
    Item
    Day
    text
    C0439228 (UMLS CUI [1])
    Dose
    Item
    Dose
    text
    C3174092 (UMLS CUI [1,1])
    C0079459 (UMLS CUI [1,2])
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C0079459 (UMLS CUI [1,2])
    Route
    Code List
    Route
    CL Item
    SC (1)
    CL Item
    IV (2)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Time
    Item
    Time
    time
    C0040223 (UMLS CUI [1])
    Item Group
    Vital Signs-TAG Regiment only
    C0518766 (UMLS CUI-1)
    C0146224 (UMLS CUI-2)
    C0733521 (UMLS CUI-3)
    C0079459 (UMLS CUI-4)
    C0013227 (UMLS CUI-5)
    Day
    Item
    Day
    text
    C0439228 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Scheduled Time
    Item
    Scheduled Time
    text
    C0040223 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1,1])
    C0237400 (UMLS CUI [1,2])
    Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
    Item
    Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
    Item
    Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Pulse After 5 Minutes Sitting
    Item
    Pulse After 5 Minutes Sitting
    integer
    C0232117 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Item Group
    Vital Signs-IDAG Regiment only-Vital signs are to be performed on Days 1, 2, and 3 prior to idarubicin infusion and post ara-C infusion. On Days 4 and 5, vital signs are to be performed prior and post ara-C infusion
    C0518766 (UMLS CUI-1)
    C0020789 (UMLS CUI-2)
    C0733521 (UMLS CUI-3)
    C0079459 (UMLS CUI-4)
    C0013227 (UMLS CUI-5)
    Day
    Item
    Day
    text
    C0439228 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Scheduled Time
    Item
    Scheduled Time
    text
    C0040223 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1,1])
    C0237400 (UMLS CUI [1,2])
    Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
    Item
    Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
    Item
    Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Pulse After 5 Minutes Sitting
    Item
    Pulse After 5 Minutes Sitting
    integer
    C0232117 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
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