ID

6479

Description

E1A06 Induction Treatment Form Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma NCT00602641 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=402A1AE1-FA70-56B0-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=402A1AE1-FA70-56B0-E044-0003BA3F9857

Keywords

  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/1/15 1/1/15 - Martin Dugas
Uploaded on

January 1, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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    Induction Treatment Form Multiple Myeloma (E1A06)

    No Instruction available.

    1. StudyEvent: E1A06 Induction Treatment Form
      1. No Instruction available.
    Header section
    Description

    Header section

    Alias
    UMLS CUI-1
    C1320722
    Patient Initials (Last, First)
    Description

    Patient Initials

    Data type

    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

    Data type

    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
    Participating Group Protocol Number
    Description

    Study Number Participating Group

    Data type

    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
    Institution/Affiliate
    Description

    Institution Name

    Data type

    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
    ECOG Patient ID
    Description

    Patient ID ECOG

    Data type

    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 Patient ID
    Description

    Trial subject ID Participating Group

    Data type

    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
    DCI Name
    Description

    Form name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C3242370
    NCI Thesaurus Property
    C19464
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus ObjectClass-2
    C25452
    Registration Step
    Description

    Registration Number

    Data type

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

    Data amended

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Date data amended (s - mm/dd/yyyy)
    Description

    Data amended date

    Data type

    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
    On Treatment Report Period (Induction Therapy: Cycles 1 - 12)
    Description

    Cycle number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25214
    NCI Thesaurus Property-2
    C25616
    NCI Thesaurus ObjectClass
    C15368
    Reporting Period Start Date (mm/dd/yyyy)
    Description

    Reporting Period Start Date

    Data type

    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 (mm/dd/yyyy)
    Description

    Reporting Period End Date

    Data type

    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

    Data type

    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 (mm/dd/yyyy)
    Description

    Date last contact

    Data type

    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
    Description

    Primary Cause of Death

    Data type

    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

    Data type

    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 (Day 1 of this reporting period cycle)
    Description

    Patient Weight

    Data type

    float

    Measurement units
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    Body Surface Area (BSA Day 1 of this reporting period cycle)
    Description

    Body Surface Area

    Data type

    float

    Measurement units
    • m2
    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C0005902
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property
    C25157
    m2
    Therapy Administered - Section I
    Description

    Therapy Administered - Section I

    Agent Name (Complete base on completed Patient Pill Diary)
    Description

    Agent

    Data type

    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? (Lenalidomide)
    Description

    Agent administered during reporting period

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0450442
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    Agent Start Date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2826734
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25275
    Total Dose of Agents/Drugs for this Cycle (mg - this report period)
    Description

    Agent Total Dose

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Were there any dose modifications or additions/omissions to Melphalan protocol treatment
    Description

    Dose modification Melphalan

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0025241
    NCI Thesaurus ObjectClass-2
    C633
    NCI Thesaurus Property
    C25572
    Was treatment modification to Melphalan planned (per protocol)? (If yes,)
    Description

    Dose modification Melphalan per protocol

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass-2
    C633
    UMLS CUI-2
    C0025241
    NCI Thesaurus Property
    C25320
    UMLS CUI-3
    C1698058
    NCI Thesaurus Property-2
    C25572
    NCI Thesaurus ValueDomain
    C38147
    Dose Modification Start Date
    Description

    Dose modification start date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0808070
    NCI Thesaurus Property
    C25572
    Dose Modification End Date
    Description

    Dose modification end date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0806020
    NCI Thesaurus Property
    C25572
    Total Modified Dose (mg)
    Description

    Total Modified Dose

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus ValueDomain-2
    C25488
    UMLS CUI-2
    C0392747
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25572
    Dose modification
    Description

    Dose Modification Status

    Data type

    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

    Data type

    text

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

    Dose Modification Reason, other

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Therapy Administered - Section I
    Description

    Therapy Administered - Section I

    Agent Name (Complete base on completed Patient Pill Diary)
    Description

    Agent

    Data type

    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? (Lenalidomide)
    Description

    Agent administered during reporting period

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0450442
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    Agent Start Date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2826734
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25275
    Total Dose of Agents/Drugs for this Cycle (mg - this report period)
    Description

    Agent Total Dose

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Were there any dose modifications or additions/omissions to Prednisone protocol treatment
    Description

    Dose modification Prednisone

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0032952
    NCI Thesaurus ObjectClass-2
    C770
    NCI Thesaurus Property
    C25572
    Was treatment modification to Prednisone planned (per protocol)?
    Description

    Dose modification Prednisone per protocol

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass-2
    C770
    UMLS CUI-2
    C0032952
    NCI Thesaurus Property
    C25320
    UMLS CUI-3
    C1698058
    NCI Thesaurus Property-2
    C25572
    NCI Thesaurus ValueDomain
    C38147
    Dose Modification Start Date
    Description

    Dose modification start date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0808070
    NCI Thesaurus Property
    C25572
    Dose Modification End Date
    Description

    Dose modification end date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0806020
    NCI Thesaurus Property
    C25572
    Total Modified Dose (mg)
    Description

    Total Modified Dose

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus ValueDomain-2
    C25488
    UMLS CUI-2
    C0392747
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25572
    Dose modification
    Description

    Dose Modification Status

    Data type

    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

    Data type

    text

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

    Dose Modification Reason, other

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Therapy Administered - Section I
    Description

    Therapy Administered - Section I

    Agent Name (Complete base on completed Patient Pill Diary)
    Description

    Agent

    Data type

    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? (Lenalidomide)
    Description

    Agent administered during reporting period

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0450442
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    Agent Start Date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2826734
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25275
    Total Dose of Agents/Drugs for this Cycle (mg - this report period)
    Description

    Agent Total Dose

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Were there any dose modifications or additions/omissions to Thalidomide protocol treatment
    Description

    Dose modification Thalidomide

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C870
    UMLS CUI-2
    C0039736
    NCI Thesaurus ObjectClass-2
    C25488
    NCI Thesaurus Property
    C25572
    Was treatment modification to Thalidomide planned (per protocol)?
    Description

    Dose modification Thalidomide per protocol

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C870
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass-2
    C25488
    UMLS CUI-2
    C0039736
    NCI Thesaurus Property
    C25320
    UMLS CUI-3
    C1698058
    NCI Thesaurus Property-2
    C25572
    NCI Thesaurus ValueDomain
    C38147
    Dose Modification Start Date
    Description

    Dose modification start date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0808070
    NCI Thesaurus Property
    C25572
    Dose Modification End Date
    Description

    Dose modification end date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0806020
    NCI Thesaurus Property
    C25572
    Total Modified Dose (mg)
    Description

    Total Modified Dose

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus ValueDomain-2
    C25488
    UMLS CUI-2
    C0392747
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25572
    Dose modification
    Description

    Dose Modification Status

    Data type

    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

    Data type

    text

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

    Dose Modification Reason, other

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Therapy Administered - Prophylaxis Treatment
    Description

    Therapy Administered - Prophylaxis Treatment

    Did patient receive protocol-specified prophylaxis treatment without delay/modification/discontinuation this report period?
    Description

    Prophylaxis treatment per protocol

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-1
    C0199176
    NCI Thesaurus ObjectClass-2
    C15843
    UMLS CUI-2
    C1698058
    NCI Thesaurus ObjectClass-3
    C1708
    NCI Thesaurus Property
    C25718
    NCI Thesaurus Property-2
    C25382
    NCI Thesaurus Property-3
    C25572
    NCI Thesaurus ValueDomain
    C38147
    Agent
    Description

    Prophylactic drug

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-1
    C0199240
    NCI Thesaurus ObjectClass-2
    C15843
    NCI Thesaurus ObjectClass-3
    C1708
    NCI Thesaurus Property
    C25382
    NCI Thesaurus ValueDomain
    C25191
    Therapy Modification Type
    Description

    Therapy Modification Type

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1299575
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25572
    Agent Start Date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2826734
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25275
    Dose Modification Reason
    Description

    Dose Modification Reason

    Data type

    text

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

    Dose Modification Reason, other

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) (this report period)
    Description

    Erythropoietin-type agents

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0014822
    NCI Thesaurus ObjectClass
    C20429
    NCI Thesaurus ObjectClass-2
    C37902
    NCI Thesaurus Property
    C25382
    Therapy Administered - Section I
    Description

    Therapy Administered - Section I

    Agent Name (Complete base on completed Patient Pill Diary)
    Description

    Agent

    Data type

    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? (Lenalidomide)
    Description

    Agent administered during reporting period

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0450442
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    Agent Start Date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2826734
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25275
    Total Dose of Agents/Drugs for this Cycle (mg - this report period)
    Description

    Agent Total Dose

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Were there any dose modifications or additions/omissions to Lenalidomide protocol treatment
    Description

    Dose modification Lenalidomide

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C2668
    UMLS CUI-2
    C1144149
    NCI Thesaurus ObjectClass-2
    C25488
    NCI Thesaurus Property
    C25572
    Was treatment modification to Lenalidomide planned (per protocol)? (If yes,)
    Description

    Dose modification Lenalidomide per protocol

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C2668
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass-2
    C25488
    UMLS CUI-2
    C1144149
    NCI Thesaurus Property
    C25320
    UMLS CUI-3
    C1698058
    NCI Thesaurus Property-2
    C25572
    NCI Thesaurus ValueDomain
    C38147
    Start Date of Dose Modification
    Description

    Dose modification begin date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1707811
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS CUI-2
    C0808070
    NCI Thesaurus ObjectClass
    C25488
    NCI Thesaurus Property
    C25572
    End Date of Dose Modification
    Description

    Dose modification end date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0806020
    NCI Thesaurus Property
    C25572
    Total Modified Dose (mg)
    Description

    Total Modified Dose

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus ValueDomain-2
    C25488
    UMLS CUI-2
    C0392747
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25572
    Dose modification
    Description

    Dose Modification Status

    Data type

    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

    Data type

    text

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

    Dose Modification Reason, other

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Section E: Non-protocol Therapy
    Description

    Section E: Non-protocol Therapy

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

    Non-protocol therapy

    Data type

    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

    Comments
    Description

    Research Comments

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Investigator Signature
    Description

    Investigator Signature

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Investigator Signature Date
    Description

    Investigator Signature Date

    Data type

    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

    No Instruction available.

    1. StudyEvent: E1A06 Induction Treatment Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header section
    C1320722 (UMLS CUI-1)
    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)
    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)
    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)
    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)
    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)
    Form name
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C3242370 (UMLS CUI-1)
    C19464 (NCI Thesaurus Property)
    C25474 (NCI Thesaurus ObjectClass)
    C25452 (NCI Thesaurus ObjectClass-2)
    Registration Number
    Item
    Registration Step
    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)
    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 - mm/dd/yyyy)
    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
    On Treatment Report Period (Induction Therapy: Cycles 1 - 12)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25616 (NCI Thesaurus Property-2)
    C15368 (NCI Thesaurus ObjectClass)
    Code List
    On Treatment Report Period (Induction Therapy: Cycles 1 - 12)
    CL Item
    Cycle 1 (Cycle 1)
    CL Item
    Cycle 2 (Cycle 2)
    CL Item
    Cycle 3 (Cycle 3)
    CL Item
    Cycle 4 (cycle 4)
    CL Item
    Cycle 5 (Cycle 5)
    CL Item
    Cycle 6 (Cycle 6)
    CL Item
    Cycle 7 (Cycle 7)
    CL Item
    Cycle 8 (cycle 8)
    CL Item
    Cycle 9 (Cycle 9)
    CL Item
    Cycle 10 (Cycle 10)
    CL Item
    Cycle 11 (Cycle 11)
    CL Item
    Cycle 12 (Cycle 12)
    Reporting Period Start Date
    Item
    Reporting Period Start Date (mm/dd/yyyy)
    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 (mm/dd/yyyy)
    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 (mm/dd/yyyy)
    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
    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
    CL Item
    Due To Other Cause (Due to other cause)
    CL Item
    Due To Protocol Treatment (Due to protocol treatment)
    CL Item
    Due To This Disease (Due to this disease)
    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 (Day 1 of this reporting period cycle)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Body Surface Area
    Item
    Body Surface Area (BSA Day 1 of this reporting period cycle)
    float
    C25190 (NCI Thesaurus ObjectClass)
    C0005902 (UMLS CUI-1)
    C25712 (NCI Thesaurus ValueDomain)
    C25157 (NCI Thesaurus Property)
    Item Group
    Therapy Administered - Section I
    Agent
    Item
    Agent Name (Complete base on completed Patient Pill Diary)
    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? (Lenalidomide)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    Concomitant Medication Start Date
    Item
    Agent Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2826734 (UMLS CUI-1)
    C25431 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    Agent Total Dose
    Item
    Total Dose of Agents/Drugs for this Cycle (mg - 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)
    Dose modification Melphalan
    Item
    Were there any dose modifications or additions/omissions to Melphalan protocol treatment
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0025241 (UMLS CUI-2)
    C633 (NCI Thesaurus ObjectClass-2)
    C25572 (NCI Thesaurus Property)
    Dose modification Melphalan per protocol
    Item
    Was treatment modification to Melphalan planned (per protocol)? (If yes,)
    boolean
    C25488 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C633 (NCI Thesaurus ObjectClass-2)
    C0025241 (UMLS CUI-2)
    C25320 (NCI Thesaurus Property)
    C1698058 (UMLS CUI-3)
    C25572 (NCI Thesaurus Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    Dose modification start date
    Item
    Dose Modification Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0808070 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Dose modification end date
    Item
    Dose Modification End Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0806020 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Total Modified Dose
    Item
    Total Modified Dose (mg)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25488 (NCI Thesaurus ValueDomain-2)
    C0392747 (UMLS CUI-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    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
    Dose Delayed (Dose delayed)
    CL Item
    Dose Held (Dose held)
    CL Item
    Dose Missed (Dose missed)
    CL Item
    Dose Escalated (Dose escalated)
    CL Item
    Dose Reduced (Dose reduced)
    C49505 (NCI Thesaurus)
    C1707814 (UMLS 2011AA)
    C49505 (NCI Thesaurus-3)
    C1707814 (UMLS 2011AA-4)
    CL Item
    Drug Discontinued (Drug discontinued)
    CL Item
    No Dose Modification (No dose modification)
    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
    Alternative Therapy For Other Reason (Alternative therapy for other reason)
    CL Item
    Dosing Error (Dosing error)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Patient Refusal/noncompliance (Patient refusal/noncompliance)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Second Primary Cancer (Second primary)
    Dose Modification Reason, other
    Item
    Other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Item Group
    Therapy Administered - Section I
    Agent
    Item
    Agent Name (Complete base on completed Patient Pill Diary)
    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? (Lenalidomide)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    Concomitant Medication Start Date
    Item
    Agent Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2826734 (UMLS CUI-1)
    C25431 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    Agent Total Dose
    Item
    Total Dose of Agents/Drugs for this Cycle (mg - 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)
    Dose modification Prednisone
    Item
    Were there any dose modifications or additions/omissions to Prednisone protocol treatment
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0032952 (UMLS CUI-2)
    C770 (NCI Thesaurus ObjectClass-2)
    C25572 (NCI Thesaurus Property)
    Dose modification Prednisone per protocol
    Item
    Was treatment modification to Prednisone planned (per protocol)?
    boolean
    C25488 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C770 (NCI Thesaurus ObjectClass-2)
    C0032952 (UMLS CUI-2)
    C25320 (NCI Thesaurus Property)
    C1698058 (UMLS CUI-3)
    C25572 (NCI Thesaurus Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    Dose modification start date
    Item
    Dose Modification Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0808070 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Dose modification end date
    Item
    Dose Modification End Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0806020 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Total Modified Dose
    Item
    Total Modified Dose (mg)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25488 (NCI Thesaurus ValueDomain-2)
    C0392747 (UMLS CUI-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    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
    Dose Delayed (Dose delayed)
    CL Item
    Dose Held (Dose held)
    CL Item
    Dose Missed (Dose missed)
    CL Item
    Dose Escalated (Dose escalated)
    CL Item
    Dose Reduced (Dose reduced)
    C49505 (NCI Thesaurus)
    C1707814 (UMLS 2011AA)
    C49505 (NCI Thesaurus-3)
    C1707814 (UMLS 2011AA-4)
    CL Item
    Drug Discontinued (Drug discontinued)
    CL Item
    No Dose Modification (No dose modification)
    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
    Alternative Therapy For Other Reason (Alternative therapy for other reason)
    CL Item
    Dosing Error (Dosing error)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Patient Refusal/noncompliance (Patient refusal/noncompliance)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Second Primary Cancer (Second primary)
    Dose Modification Reason, other
    Item
    Other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Item Group
    Therapy Administered - Section I
    Agent
    Item
    Agent Name (Complete base on completed Patient Pill Diary)
    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? (Lenalidomide)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    Concomitant Medication Start Date
    Item
    Agent Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2826734 (UMLS CUI-1)
    C25431 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    Agent Total Dose
    Item
    Total Dose of Agents/Drugs for this Cycle (mg - 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)
    Dose modification Thalidomide
    Item
    Were there any dose modifications or additions/omissions to Thalidomide protocol treatment
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C870 (NCI Thesaurus ObjectClass)
    C0039736 (UMLS CUI-2)
    C25488 (NCI Thesaurus ObjectClass-2)
    C25572 (NCI Thesaurus Property)
    Dose modification Thalidomide per protocol
    Item
    Was treatment modification to Thalidomide planned (per protocol)?
    boolean
    C870 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass-2)
    C0039736 (UMLS CUI-2)
    C25320 (NCI Thesaurus Property)
    C1698058 (UMLS CUI-3)
    C25572 (NCI Thesaurus Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    Dose modification start date
    Item
    Dose Modification Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0808070 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Dose modification end date
    Item
    Dose Modification End Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0806020 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Total Modified Dose
    Item
    Total Modified Dose (mg)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25488 (NCI Thesaurus ValueDomain-2)
    C0392747 (UMLS CUI-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    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
    Dose Delayed (Dose delayed)
    CL Item
    Dose Held (Dose held)
    CL Item
    Dose Missed (Dose missed)
    CL Item
    Dose Escalated (Dose escalated)
    CL Item
    Dose Reduced (Dose reduced)
    C49505 (NCI Thesaurus)
    C1707814 (UMLS 2011AA)
    C49505 (NCI Thesaurus-3)
    C1707814 (UMLS 2011AA-4)
    CL Item
    Drug Discontinued (Drug discontinued)
    CL Item
    No Dose Modification (No dose modification)
    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
    Alternative Therapy For Other Reason (Alternative therapy for other reason)
    CL Item
    Dosing Error (Dosing error)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Patient Refusal/noncompliance (Patient refusal/noncompliance)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Second Primary Cancer (Second primary)
    Dose Modification Reason, other
    Item
    Other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Item Group
    Therapy Administered - Prophylaxis Treatment
    Prophylaxis treatment per protocol
    Item
    Did patient receive protocol-specified prophylaxis treatment without delay/modification/discontinuation this report period?
    boolean
    C25320 (NCI Thesaurus ObjectClass)
    C0199176 (UMLS CUI-1)
    C15843 (NCI Thesaurus ObjectClass-2)
    C1698058 (UMLS CUI-2)
    C1708 (NCI Thesaurus ObjectClass-3)
    C25718 (NCI Thesaurus Property)
    C25382 (NCI Thesaurus Property-2)
    C25572 (NCI Thesaurus Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    Item
    Agent
    text
    C25320 (NCI Thesaurus ObjectClass)
    C0199240 (UMLS CUI-1)
    C15843 (NCI Thesaurus ObjectClass-2)
    C1708 (NCI Thesaurus ObjectClass-3)
    C25382 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    Code List
    Agent
    CL Item
    Aspirin 325mg (Aspirin 325mg)
    CL Item
    Aspirin 81mg (Aspirin 81 mg)
    CL Item
    Aspirin, Other (Aspirin, other)
    CL Item
    Coumadin (prophylactic Dose) (Coumadin)
    CL Item
    Low Molecular Weight Heparin (prophylactic Dose) (Low Molecular Weight Heparin)
    CL Item
    Not Applicable (Not applicable)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    Item
    Therapy Modification Type
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1299575 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    Code List
    Therapy Modification Type
    CL Item
    Agent Changed (Agent changed)
    CL Item
    Agent Discontinued (Agent discontinued)
    CL Item
    Dose Delayed (Dose delay)
    CL Item
    Dose Missed (Dose missed)
    CL Item
    Dose Or Inr Modfication (Dose or INR modfication)
    Concomitant Medication Start Date
    Item
    Agent Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2826734 (UMLS CUI-1)
    C25431 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    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
    Alternative Therapy For Other Reason (Alternative therapy for other reason)
    CL Item
    Dosing Error (Dosing error)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Patient Refusal/noncompliance (Patient refusal/noncompliance)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Second Primary Cancer (Second primary)
    Dose Modification Reason, other
    Item
    Other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Erythropoietin-type agents
    Item
    Has the patient received erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) (this report period)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0014822 (UMLS CUI-1)
    C20429 (NCI Thesaurus ObjectClass)
    C37902 (NCI Thesaurus ObjectClass-2)
    C25382 (NCI Thesaurus Property)
    Item Group
    Therapy Administered - Section I
    Agent
    Item
    Agent Name (Complete base on completed Patient Pill Diary)
    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? (Lenalidomide)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    Concomitant Medication Start Date
    Item
    Agent Start Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2826734 (UMLS CUI-1)
    C25431 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    Agent Total Dose
    Item
    Total Dose of Agents/Drugs for this Cycle (mg - 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)
    Dose modification Lenalidomide
    Item
    Were there any dose modifications or additions/omissions to Lenalidomide protocol treatment
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C2668 (NCI Thesaurus ObjectClass)
    C1144149 (UMLS CUI-2)
    C25488 (NCI Thesaurus ObjectClass-2)
    C25572 (NCI Thesaurus Property)
    Dose modification Lenalidomide per protocol
    Item
    Was treatment modification to Lenalidomide planned (per protocol)? (If yes,)
    boolean
    C2668 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass-2)
    C1144149 (UMLS CUI-2)
    C25320 (NCI Thesaurus Property)
    C1698058 (UMLS CUI-3)
    C25572 (NCI Thesaurus Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    Dose modification begin date
    Item
    Start Date of Dose Modification
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0808070 (UMLS CUI-2)
    C25488 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    Dose modification end date
    Item
    End Date of Dose Modification
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0806020 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Total Modified Dose
    Item
    Total Modified Dose (mg)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25488 (NCI Thesaurus ValueDomain-2)
    C0392747 (UMLS CUI-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    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
    Dose Delayed (Dose delayed)
    CL Item
    Dose Held (Dose held)
    CL Item
    Dose Missed (Dose missed)
    CL Item
    Dose Escalated (Dose escalated)
    CL Item
    Dose Reduced (Dose reduced)
    C49505 (NCI Thesaurus)
    C1707814 (UMLS 2011AA)
    C49505 (NCI Thesaurus-3)
    C1707814 (UMLS 2011AA-4)
    CL Item
    Drug Discontinued (Drug discontinued)
    CL Item
    No Dose Modification (No dose modification)
    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
    Alternative Therapy For Other Reason (Alternative therapy for other reason)
    CL Item
    Dosing Error (Dosing error)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Patient Refusal/noncompliance (Patient refusal/noncompliance)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Second Primary Cancer (Second primary)
    Dose Modification Reason, other
    Item
    Other, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Item Group
    Section E: 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
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    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
    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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