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

Versions (2)
  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)

English

No Instruction available.

1 forms  
  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
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1 forms
  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)
CL.1
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)
CL.2
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)
CL.3
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)
CL.28
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)
CL.29
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)
CL.28
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)
CL.29
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)
CL.28
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)
CL.29
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)
CL.22
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)
CL.21
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)
CL.29
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)
CL.28
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)
CL.29
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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