ID

6748

Description

E2906 Treatment Form - CONSOLIDATION - Arm D - Step 2 Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74CEC72C-CDF5-2C0E-E040-BB89AD4367D1

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=74CEC72C-CDF5-2C0E-E040-BB89AD4367D1

Mots-clés

  1. 19/09/2012 19/09/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
Téléchargé le

8 janvier 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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    Leukemia NCT01041703 Treatment - E2906 Treatment Form - CONSOLIDATION - Arm D - Step 2 - 2949249v1.0

    INSTRUCTIONS: Complete this form at the end of each cycle of Arm B Consolidation protocol treatment. Submit original to the ECOG Coordinating Center. Keep a copy for your files. Refer to forms packet for submission schedule

    Header
    Description

    Header

    DCI Name
    Description

    Generic drug form

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C3242750
    NCI Thesaurus Property
    C19464
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus ObjectClass-2
    C25452
    Registration Step (Place ID Label Here)
    Description

    Registration Number

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    Patient Initials (Last, First)
    Description

    Patient Initials

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    ECOG Protocol Number
    Description

    Protocol Number ECOG

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Protocol Number
    Description

    Protocol Number ECOG

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Patient ID
    Description

    Patient ID ECOG

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Patient ID
    Description

    Patient ID ECOG

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    Participating Group Protocol Number
    Description

    Study Number Participating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Participating Group Patient ID
    Description

    Trial subject ID Participating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Institution/Affiliate
    Description

    Institution Name

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    On Treatment
    Description

    On Treatment

    Reporting Period
    Description

    Clinical Trial Period

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2347804
    NCI Thesaurus ObjectClass
    C25214
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass-2
    C25651
    Unnamed2
    Description

    Unnamed2

    Please mark an 'X' if data have been amended. (Please circle amended items in red)
    Description

    Data amended

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Date data amended (s M D Y)
    Description

    Data amended date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property
    C25416
    NCI Thesaurus ValueDomain-2
    C25367
    Section Ii - Reporting Period
    Description

    Section Ii - Reporting Period

    Reporting Period Start Date (M D Y)
    Description

    Reporting Period Start Date

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25616
    UMLS CUI-1
    C2361257
    NCI Thesaurus Property-2
    C25651
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Reporting Period End Date (M D Y)
    Description

    Reporting Period End Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2361259
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25651
    Vital Status
    Description

    Vital Status

    Patient's Vital Status
    Description

    Patient Status

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C3846084
    NCI Thesaurus ValueDomain
    C18003
    NCI Thesaurus ValueDomain-2
    C25688
    NCI Thesaurus Property
    C25717
    Date of Last Contact or Death (M D Y)
    Description

    Date last contact

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C0805839
    NCI Thesaurus Property
    C25461
    NCI Thesaurus Property-2
    C25551
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Primary Cause of Death (if applicable)
    Description

    Primary Cause of Death

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C28554
    NCI Thesaurus ValueDomain-2
    C25251
    Describe cause of death
    Description

    Cause of Death, specify

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1521902
    NCI Thesaurus Property
    C28554
    Patient Characteristics
    Description

    Patient Characteristics

    Weight (kg Day 1 of this treatment [Note: code weight loss/gain >= grade 1 per CTCAE on E2906 Adverse Event Form])
    Description

    Patient Weight

    Type de données

    float

    Unités de mesure
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    Body Surface Area (m^2 Patient Measurement BSA Day 1 of this treatment)
    Description

    Body Surface Area

    Type de données

    float

    Unités de mesure
    • m2
    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C0005902
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property
    C25157
    m2
    Age group
    Description

    PatientFirstProtocolRegistrationAgeYearCount

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25320
    UMLS 2011AA Property
    C1507394
    NCI Thesaurus Property-2
    C25646
    UMLS 2011AA Property-2
    C1514821
    NCI Thesaurus Property-3
    C25509
    UMLS 2011AA Property-3
    C1279901
    NCI Thesaurus ValueDomain
    C29848
    UMLS 2011AA ValueDomain
    C0439234
    NCI Thesaurus ValueDomain-2
    C25463
    UMLS 2011AA ValueDomain-2
    C0750480
    Therapy Administered
    Description

    Therapy Administered

    Agent Name
    Description

    Agent

    Type de données

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Was the agent administered during this reporting period? (cycle)
    Description

    Agent administered during reporting period

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0450442
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    Date of First dose for this reporting period (M D Y)
    Description

    Treatment Start Date

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25509
    UMLS CUI-1
    C3173309
    NCI Thesaurus Property-2
    C25256
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Date of Last dose for this reporting period (M D Y)
    Description

    Date Last Dose

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1762893
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25509
    NCI Thesaurus Property-2
    C25256
    Agent Total Dose (mg/m^2 this report period)
    Description

    Agent Total Dose

    Type de données

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Dose modification
    Description

    Dose Modification Status

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-1
    C1707811
    NCI Thesaurus ValueDomain
    C25688
    NCI Thesaurus Property
    C25572
    Dose Modification Reason
    Description

    Dose Modification Reason

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property
    C25572
    Other Therapy Administered
    Description

    Other Therapy Administered

    Agent Name
    Description

    Agent

    Type de données

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Did patient receive Dexamethasone this reporting period (as an anti-emetic cycle)
    Description

    DexamethasoneAgentAdministrationInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ObjectClass-2
    C422
    UMLS 2011AA ObjectClass-2
    C0011777
    NCI Thesaurus Property
    C25409
    UMLS 2011AA Property
    C1533734
    Non-protocol Therapy
    Description

    Non-protocol Therapy

    Was any non-protocol therapy given during protocol treatment? (not previously reported )
    Description

    Non-protocol therapy

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25590
    UMLS CUI-1
    C1518384
    NCI Thesaurus ObjectClass-2
    C16212
    UMLS CUI-2
    C0087111
    NCI Thesaurus Property
    C25320
    NCI Thesaurus Property-2
    C49236
    NCI Thesaurus Property-3
    C25456
    NCI Thesaurus Property-4
    C25382
    NCI Thesaurus ValueDomain
    C38148
    Comments
    Description

    Comments

    Investigator Signature
    Description

    Investigator Signature

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Investigator Signature Date (MM DD YYYY)
    Description

    Investigator Signature Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    UMLS CUI-2
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C17089

    Similar models

    INSTRUCTIONS: Complete this form at the end of each cycle of Arm B Consolidation protocol treatment. Submit original to the ECOG Coordinating Center. Keep a copy for your files. Refer to forms packet for submission schedule

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Header
    Generic drug form
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C3242750 (UMLS CUI-1)
    C19464 (NCI Thesaurus Property)
    C25474 (NCI Thesaurus ObjectClass)
    C25452 (NCI Thesaurus ObjectClass-2)
    Registration Number
    Item
    Registration Step (Place ID Label Here)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    Patient Initials
    Item
    Patient Initials (Last, First)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Study Number Participating Group
    Item
    Participating Group Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Item Group
    On Treatment
    Item
    Reporting Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2347804 (UMLS CUI-1)
    C25214 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C25651 (NCI Thesaurus ObjectClass-2)
    Code List
    Reporting Period
    CL Item
    Cycle 1 - Consolidation (Cycle 1 - Consolidation)
    CL Item
    Cycle 2 - Consolidation (Cycle 2 - Consolidation)
    Item Group
    Unnamed2
    Data amended
    Item
    Please mark an 'X' if data have been amended. (Please circle amended items in red)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Data amended date
    Item
    Date data amended (s M D Y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C0011008 (UMLS CUI-2)
    C25416 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item Group
    Section Ii - Reporting Period
    Reporting Period Start Date
    Item
    Reporting Period Start Date (M D Y)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C2361257 (UMLS CUI-1)
    C25651 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Reporting Period End Date
    Item
    Reporting Period End Date (M D Y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2361259 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25651 (NCI Thesaurus Property-2)
    Item Group
    Vital Status
    Item
    Patient's Vital Status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C3846084 (UMLS CUI-1)
    C18003 (NCI Thesaurus ValueDomain)
    C25688 (NCI Thesaurus ValueDomain-2)
    C25717 (NCI Thesaurus Property)
    Code List
    Patient's Vital Status
    CL Item
    Alive (Alive)
    CL Item
    Dead (Dead)
    Date last contact
    Item
    Date of Last Contact or Death (M D Y)
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0805839 (UMLS CUI-1)
    C25461 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item
    Primary Cause of Death (if applicable)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0007465 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C28554 (NCI Thesaurus Property)
    C25251 (NCI Thesaurus ValueDomain-2)
    Code List
    Primary Cause of Death (if applicable)
    CL Item
    Due To Protocol Treatment (Due to protocol treatment)
    CL Item
    Due To This Disease (Due to this disease)
    CL Item
    Due To Other Cause (Due to other cause)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Cause of Death, specify
    Item
    Describe cause of death
    text
    C25685 (NCI Thesaurus ValueDomain)
    C0007465 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1521902 (UMLS CUI-2)
    C28554 (NCI Thesaurus Property)
    Item Group
    Patient Characteristics
    Patient Weight
    Item
    Weight (kg Day 1 of this treatment [Note: code weight loss/gain >= grade 1 per CTCAE on E2906 Adverse Event Form])
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Body Surface Area
    Item
    Body Surface Area (m^2 Patient Measurement BSA Day 1 of this treatment)
    float
    C25190 (NCI Thesaurus ObjectClass)
    C0005902 (UMLS CUI-1)
    C25712 (NCI Thesaurus ValueDomain)
    C25157 (NCI Thesaurus Property)
    Item
    Age group
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25320 (NCI Thesaurus Property)
    C1507394 (UMLS 2011AA Property)
    C25646 (NCI Thesaurus Property-2)
    C1514821 (UMLS 2011AA Property-2)
    C25509 (NCI Thesaurus Property-3)
    C1279901 (UMLS 2011AA Property-3)
    C29848 (NCI Thesaurus ValueDomain)
    C0439234 (UMLS 2011AA ValueDomain)
    C25463 (NCI Thesaurus ValueDomain-2)
    C0750480 (UMLS 2011AA ValueDomain-2)
    Code List
    Age group
    CL Item
    Age 60-69 Years Of Age (Age 60-69 years of age)
    CL Item
    Age >=70 Years Of Age (Age >=70 years of age)
    Item Group
    Therapy Administered
    Agent
    Item
    Agent Name
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Agent administered during reporting period
    Item
    Was the agent administered during this reporting period? (cycle)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    Treatment Start Date
    Item
    Date of First dose for this reporting period (M D Y)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25509 (NCI Thesaurus Property)
    C3173309 (UMLS CUI-1)
    C25256 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Date Last Dose
    Item
    Date of Last dose for this reporting period (M D Y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1762893 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25509 (NCI Thesaurus Property)
    C25256 (NCI Thesaurus Property-2)
    Agent Total Dose
    Item
    Agent Total Dose (mg/m^2 this report period)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25379 (NCI Thesaurus Property)
    C25488 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    Item
    Dose modification
    text
    C25488 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C25688 (NCI Thesaurus ValueDomain)
    C25572 (NCI Thesaurus Property)
    Code List
    Dose modification
    CL Item
    No Dose Modification (No dose modification)
    CL Item
    Dose Held (Dose held)
    CL Item
    Dose Delayed (Dose delayed)
    CL Item
    Dose Reduced (Dose reduced)
    C49505 (NCI Thesaurus)
    C1707814 (UMLS 2011AA)
    C49505 (NCI Thesaurus-3)
    C1707814 (UMLS 2011AA-4)
    CL Item
    Dose Delayed And Reduced (Dose delayed and reduced)
    Item
    Dose Modification Reason
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Code List
    Dose Modification Reason
    CL Item
    Adverse Event (Adverse event)
    C41331 (NCI Thesaurus)
    C0877248 (UMLS 2011AA)
    CL Item
    Patient Refusal/noncompliance (Patient refusal/noncompliance)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Dosing Error (Dosing error)
    CL Item
    Change In Bsa (Change in BSA)
    Item Group
    Other Therapy Administered
    Agent
    Item
    Agent Name
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    DexamethasoneAgentAdministrationInd-2
    Item
    Did patient receive Dexamethasone this reporting period (as an anti-emetic cycle)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C422 (NCI Thesaurus ObjectClass-2)
    C0011777 (UMLS 2011AA ObjectClass-2)
    C25409 (NCI Thesaurus Property)
    C1533734 (UMLS 2011AA Property)
    Item Group
    Non-protocol Therapy
    Non-protocol therapy
    Item
    Was any non-protocol therapy given during protocol treatment? (not previously reported )
    boolean
    C25590 (NCI Thesaurus ObjectClass)
    C1518384 (UMLS CUI-1)
    C16212 (NCI Thesaurus ObjectClass-2)
    C0087111 (UMLS CUI-2)
    C25320 (NCI Thesaurus Property)
    C49236 (NCI Thesaurus Property-2)
    C25456 (NCI Thesaurus Property-3)
    C25382 (NCI Thesaurus Property-4)
    C38148 (NCI Thesaurus ValueDomain)
    Item Group
    Comments
    Investigator Signature
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    Investigator Signature Date
    Item
    Investigator Signature Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C25367 (NCI Thesaurus ValueDomain-2)
    C17089 (NCI Thesaurus ObjectClass)

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