ID

2724

Description

E3A06 Multiple Myeloma On-Study Form Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=86CCB2A8-771D-F281-E040-BB89AD432A9E

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=86CCB2A8-771D-F281-E040-BB89AD432A9E

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/16/15 6/16/15 -
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Multiple Myeloma and Plasma Cell Neoplasm NCT01169337 On-Study - E3A06 Multiple Myeloma On-Study Form - 3086398v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: E3A06 Multiple Myeloma On-Study Form
    1. No Instruction available.
Unnamed1
Description

Unnamed1

DCI Name
Description

CollectedDataFormName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus ObjectClass
C25452
Registration Step
Description

RegistrationStepNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Report Period (Place ID Label Here)
Description

ReportingPeriod

Data type

text

Patient Initials (Last, First)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
Participating Group Protocol Number
Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Patient ID
Description

PatientParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Unnamed2
Description

Unnamed2

Please mark an 'X' if data have been amended.
Description

DataAmendedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Date data amended
Description

DataAmendedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
NCI Thesaurus ValueDomain
C25367
Disease Description - Initial Diagnosis
Description

Disease Description - Initial Diagnosis

Date of Initial Pathologic Diagnosis
Description

CancerInitialDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Current Clinical Date
Description

Current Clinical Date

Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Height (cm)
Description

PatientHeightMeasurement

Data type

double

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
cm
Bone Pain (on entry of study)
Description

PainBoneSymptomType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3303
UMLS 2011AA ObjectClass
C0030193
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
Is severe osteoporosis present? (unrelated to myeloma)
Description

DiseaseSevereOsteoporosisDiagnosisInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C3298
UMLS 2011AA Property
C0029456
NCI Thesaurus Property
C70667
UMLS 2011AA Property
C0205082
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Has the patient received bisphosphonates (for osteoporosis )
Description

BisphosphonateSupportAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C443
UMLS 2011AA ObjectClass
C0012544
NCI Thesaurus ObjectClass
C37902
UMLS 2011AA ObjectClass
C1521721
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Is the patient on anticoagulant therapy (ONLY for deep vein thrombosis)
Description

AnticoagulantAgentAdministeredind-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C263
UMLS 2011AA ObjectClass
C0003280
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Baseline Abnormalities
Description

Baseline Abnormalities

CTC Adverse Event Term (Use CTCAE v4.0 terminology)
Description

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain
C49704
UMLS 2011AA ValueDomain
C1516728
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
NCI Thesaurus ValueDomain
C45559
UMLS 2011AA ValueDomain
C1705313
NCI Thesaurus ValueDomain
C25714
UMLS 2011AA ValueDomain
C0333052
CTC Adverse Event Grade (v4.0 Use grade 1-4 per CTCAE)
Description

AdverseEventSeverityGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property
C49705
UMLS 2011AA Property
C1710065
NCI Thesaurus Property
C25676
UMLS 2011AA Property
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain
C48309
UMLS 2011AA ValueDomain
C0441800
NCI Thesaurus ValueDomain
C25676
UMLS 2011AA ValueDomain
C0439793
Comments
Description

Comments

Investigator Signature
Description

InvestigatorSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Signature Date
Description

InvestigatorSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
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1 forms
  1. StudyEvent: E3A06 Multiple Myeloma On-Study Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
CollectedDataFormName
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
Item
Report Period (Place ID Label Here)
text
CL.1
Code List
Report Period (Place ID Label Here)
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
PatientInitialsName
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
Item Group
Unnamed2
DataAmendedText
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
DataAmendedDate
Item
Date data amended
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
Item Group
Disease Description - Initial Diagnosis
CancerInitialDiagnosisDate
Item
Date of Initial Pathologic Diagnosis
date
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
Item Group
Current Clinical Date
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.2
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
PatientHeightMeasurement
Item
Height (cm)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
Item
Bone Pain (on entry of study)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3303 (NCI Thesaurus ObjectClass)
C0030193 (UMLS 2011AA ObjectClass)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
CL.3
Code List
Bone Pain (on entry of study)
CL Item
None (none)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Mild Requires Only Non-narcotic Medication (mild, requires use of non-narcotic pain relief)
CL Item
Requires Occasional Narcotics (requires occasional narcotics)
CL Item
Requires Per Os Narcotics (requires per os narcotics)
CL Item
Requires Parenteral Narcotics Or Patch (requires parenteral narcotics, or patch)
CL Item
Uncontrollable Pain (uncontrollable pain)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Is severe osteoporosis present? (unrelated to myeloma)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3298 (NCI Thesaurus Property)
C0029456 (UMLS 2011AA Property)
C70667 (NCI Thesaurus Property)
C0205082 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.4
Code List
Is severe osteoporosis present? (unrelated to myeloma)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Has the patient received bisphosphonates (for osteoporosis )
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C443 (NCI Thesaurus ObjectClass)
C0012544 (UMLS 2011AA ObjectClass)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.5
Code List
Has the patient received bisphosphonates (for osteoporosis )
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Is the patient on anticoagulant therapy (ONLY for deep vein thrombosis)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.6
Code List
Is the patient on anticoagulant therapy (ONLY for deep vein thrombosis)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Baseline Abnormalities
Item
CTC Adverse Event Term (Use CTCAE v4.0 terminology)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
CL.7
Code List
CTC Adverse Event Term (Use CTCAE v4.0 terminology)
CL Item
Fatigue (Fatigue)
E11098 (CTCAE)
Item
CTC Adverse Event Grade (v4.0 Use grade 1-4 per CTCAE)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property)
C1710065 (UMLS 2011AA Property)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)
CL.8
Code List
CTC Adverse Event Grade (v4.0 Use grade 1-4 per CTCAE)
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
Item Group
Comments
InvestigatorSignatureText
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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