ID

6477

Description

E3A06 Treatment Form (Arm A) Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma NCT01169337 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=86D1B322-221A-3014-E040-BB89AD432E00

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=86D1B322-221A-3014-E040-BB89AD432E00

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  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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Treatment Form Multiple Myeloma E3A06 Arm A

English

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

1 forms  
Header Module
Description

Header Module

Alias
UMLS CUI-1
C1320722
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
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
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 (Place ID Label Here)
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
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
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
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
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
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
Description

Data amended date

Data type

date

Measurement units
  • M D Y
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI-1
C0680532
UMLS CUI-2
C0011008
M D Y
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

Measurement units
  • MM DD YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus Property
C25678
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
UMLS CUI-1
C2346576
UMLS CUI-2
C0011008
MM DD YYYY
On Treatment
Description

On Treatment

On Treatment Report Period
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
Specify Cycle
Description

Chemotherapy cycle

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS CUI-1
C1302181
NCI Thesaurus Property-2
C25616
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ValueDomain-2
C25472
NCI Thesaurus ValueDomain-3
C25275
Reporting Period Start Date
Description

Reporting Period Start Date

Data type

date

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

Reporting Period End Date

Data type

date

Measurement units
  • M D Y
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
UMLS CUI-1
C2361259
M D Y
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 (M D Y)
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 (if applicable)
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 (kg Day 1 of this treatment)
Description

Patient Weight

Data type

float

Measurement units
  • kg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
UMLS CUI-1
C0005910
kg
Therapy Administered
Description

Therapy Administered

Alias
UMLS CUI-1
C0087111
Agent Name (Lenalidomide)
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? (Lenalidomidecycle)
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
Did the patient complete Patient Pill Diary
Description

Patient Diary complete

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C3259162
NCI Thesaurus Property
C25250
NCI Metathesaurus ObjectClass
C0030705
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
Agent Total Dose (this report period)
Description

Agent Total Dose

Data type

float

Measurement units
  • mg
Alias
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C2986497
mg
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)?
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 (daily mg)
Description

Total Modified Dose

Data type

float

Measurement units
  • mg
Alias
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25572
UMLS CUI-1
C2986497
UMLS CUI-2
C0392747
mg
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
Did patient receive thrombosis prophylaxis
Description

Deep Vein Thrombosis prophylaxis

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C49343
UMLS CUI-1
C0853245
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C25639
NCI Thesaurus ValueDomain
C38147
DVT prophylaxis Daily dose prescribed (If yes)
Description

DVT prophylaxis daily dose

Data type

text

Alias
NCI Thesaurus ObjectClass
C49343
NCI Thesaurus ObjectClass-2
C15405
NCI Thesaurus Property
C25473
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0853245
UMLS CUI-2
C2348070
Specify dose (if Aspirin given)
Description

Aspirin dose

Data type

float

Measurement units
  • mg
Alias
NCI Thesaurus ObjectClass
C49343
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15405
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C25639
NCI Thesaurus Property-3
C287
NCI Thesaurus Property-4
C25256
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C0004057
UMLS CUI-2
C0178602
mg
if Coumadin, specify (International Normal Ratio INR at the end of report period - choose one)
Description

INR

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0525032
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C25352
Was the next cycle of treatment delayed
Description

Chemotherapy delayed

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25477
NCI Thesaurus Property-2
C25472
UMLS CUI-1
C1299577
NCI Thesaurus Property-3
C53286
NCI Thesaurus ValueDomain
C38147
Non-protocol Therapy
Description

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
C1320722 (UMLS CUI-1)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
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 (Place ID Label Here)
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
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
date
C25164 (NCI Thesaurus ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
C0680532 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
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)
C25678 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
C2346576 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Item Group
On Treatment
Item
On Treatment Report Period
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
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)
CL Item
Cycle 13 (Cycle 13)
CL Item
Cycle 14 (Cycle 14)
CL Item
Cycle 15 (Cycle 15)
CL Item
Cycle 16 (Cycle 16)
CL Item
Cycle 17 (Cycle 17)
CL Item
Cycle 18 (Cycle 18)
CL Item
Cycle 19 (Cycle 19)
CL Item
> Cycle 19 (> Cycle 19)
Chemotherapy cycle
Item
Specify Cycle
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C1302181 (UMLS CUI-1)
C25616 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C25472 (NCI Thesaurus ValueDomain-2)
C25275 (NCI Thesaurus ValueDomain-3)
Reporting Period Start Date
Item
Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C2361257 (UMLS CUI-1)
Reporting Period End Date
Item
Reporting Period End Date
date
C25164 (NCI Thesaurus ValueDomain)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
C2361259 (UMLS CUI-1)
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 (M D Y)
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Primary Cause of Death (if applicable)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
CL.3
Code List
Primary Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item Group
Patient Characteristics
Patient Weight
Item
Weight (kg Day 1 of this treatment)
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI-1)
Item Group
Therapy Administered
C0087111 (UMLS CUI-1)
Agent
Item
Agent Name (Lenalidomide)
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? (Lenalidomidecycle)
boolean
C38147 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
Patient Diary complete
Item
Did the patient complete Patient Pill Diary
boolean
C38148 (NCI Thesaurus ValueDomain)
C3259162 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C0030705 (NCI Metathesaurus ObjectClass)
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
Agent Total Dose (this report period)
float
C25304 (NCI Thesaurus ValueDomain)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C2986497 (UMLS CUI-1)
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)?
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 (daily mg)
float
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C2986497 (UMLS CUI-1)
C0392747 (UMLS CUI-2)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
CL.8
Code List
Dose modification
CL Item
Dose Held (Dose held)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Escalated (Dose escalated)
CL Item
Dose Missed (Dose missed)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
Item
Dose Modification Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.14
Code List
Dose Modification Reason
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Patient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Scheduling (Scheduling)
CL Item
Dosing Error (Dosing error)
CL Item
Alternative Therapy For Other Reason (Alternative therapy for other reason)
CL Item
Second Primary Cancer (Second primary)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
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)
Deep Vein Thrombosis prophylaxis
Item
Did patient receive thrombosis prophylaxis
boolean
C49343 (NCI Thesaurus ObjectClass)
C0853245 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C25639 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
Item
DVT prophylaxis Daily dose prescribed (If yes)
text
C49343 (NCI Thesaurus ObjectClass)
C15405 (NCI Thesaurus ObjectClass-2)
C25473 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0853245 (UMLS CUI-1)
C2348070 (UMLS CUI-2)
CL.11
Code List
DVT prophylaxis Daily dose prescribed (If yes)
CL Item
325mg (aspirin) (325mg)
CL Item
Aspirin (other Dose) (Aspirin (Other Dose))
CL Item
Levonox 40mg (Levonox 40mg)
CL Item
Warfarin Sodium (Coumadin)
C1658 (NCI Thesaurus)
C0376218 (UMLS 2011AA)
Aspirin dose
Item
Specify dose (if Aspirin given)
float
C49343 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15405 (NCI Thesaurus ObjectClass-3)
C17649 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C287 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C25488 (NCI Thesaurus ValueDomain)
C0004057 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Item
if Coumadin, specify (International Normal Ratio INR at the end of report period - choose one)
text
C25284 (NCI Thesaurus ValueDomain)
C0525032 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25352 (NCI Thesaurus Property-2)
CL.12
Code List
if Coumadin, specify (International Normal Ratio INR at the end of report period - choose one)
CL Item
>2.5 (>2.5)
CL Item
1.5-2.5 (1.5-2.5)
CL Item
<1.5 (<1.5)
Chemotherapy delayed
Item
Was the next cycle of treatment delayed
boolean
C15368 (NCI Thesaurus ObjectClass)
C25477 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C1299577 (UMLS CUI-1)
C53286 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
Item Group
Non-protocol Therapy
Non-protocol therapy
Item
Was any non-protocol therapy given during protocol treatment? (not previously reported )
boolean
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS CUI-1)
C16212 (NCI Thesaurus ObjectClass-2)
C0087111 (UMLS CUI-2)
C25320 (NCI Thesaurus Property)
C49236 (NCI Thesaurus Property-2)
C25456 (NCI Thesaurus Property-3)
C25382 (NCI Thesaurus Property-4)
C38148 (NCI Thesaurus ValueDomain)
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