ID

10030

Description

ANBL0321: End of Course Worksheet Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C42A83E1-AFEA-713E-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C42A83E1-AFEA-713E-E034-0003BA12F5E7

Keywords

Versions (5)
  1. 9/20/12 9/20/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 3/19/15 3/19/15 - Martin Dugas
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March 19, 2015

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Neuroblastoma (NCT00053326)

English

No Instruction available.

1 forms  
  1. StudyEvent: ANBL0321: End of Course Worksheet
    1. No Instruction available.
Header
Description

Header

Study Number
Description

Protocol ID COG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516477
NCI Thesaurus Property
C25364
Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
COG Number
Description

PatientCOGIdentifierNumber

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-2
C39353
UMLS 2011AA Property-2
C1516477
Patient Name
Description

Patient Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1299487
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
Today's date
Description

Form Completion Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Date worksheet entered into RDE
Description

DataEnteredDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C37949
UMLS 2011AA Property
C1521975
Comments regarding this patient's course of therapy
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Tumor therapy
Description

Tumor therapy

Course number
Description

TreatmentCurrentCourseNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C15368
Course start date
Description

Chemotherapy Cycle Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C3173309
NCI Thesaurus Property
C25379
Course end date
Description

Chemotherapy Cycle End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS CUI-2
C0806020
did the patient have any of the following results: AST/ALT>2.5 times normal; Skin toxicity>Grade 1; Serum triglycerides>300mg/dL; Serum calcium>11.6mg/dL; No hematuria and/or proteinuria<1+ on urinalysis; Age adjusted abnormal serum creatinine
Description

didthepatienthaveanyofthefollowingresults:AST/ALT>2.5timesnormal;Skintoxicity>Grade1;Serumtriglycerides>300mg/dL;Serumcalcium>11.6mg/dL;Nohematuriaand/orproteinuria<1+onurinalysis;Ageadjustedabnormalserumcreatinine

Data type

boolean

agent name
Description

agent name

Data type

text

Alias
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
UMLS CUI-1
C1521826
agent UOM
Description

agent UOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25256
NCI Thesaurus ValueDomain
C25709
UMLS CUI-1
C1519795
Total mg dose of Fenretinide received during this course
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
Was there a delay in giving treatment during this course?
Description

Chemotherapy delayed

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1299577
NCI Thesaurus Property
C25477
NCI Thesaurus Property-2
C25472
NCI Thesaurus ObjectClass
C15368
why was there a delay?
Description

TreatmentDelayedReasonText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Is patient off protocol therapy at the end of this course?
Description

PatientOff-treatmentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
date last Fenretinide was received
Description

Date Last Dose

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1762893
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25256
reason off protocol therapy
Description

Off Treatment Reason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS CUI-1
C1518544
NCI Thesaurus Property
C25365
UMLS CUI-2
C0566251
What tests were done to document response?
Description

NeuroblastomaResponseAssessmentType

Data type

text

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
Did the patient achieve a response?
Description

TumorResponseInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ValueDomain-2
C25755
UMLS 2011AA ValueDomain-2
C0871261
what type of response was achieved?
Description

whattypeofresponsewasachieved?

Data type

text

what type of response was achieved? (For MIBG positive lesions:)
Description

TumorResponseType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
what was the date of response?
Description

ResponseConfirmedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
What is the patient's overall response?
Description

OverallTumorResponseType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25605
UMLS 2011AA ObjectClass-2
C1561607
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
Did patient receive radiation therapy during this course?
Description

RTTreatmentInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C15368
specify sites [of RT]
Description

Radiation Therapy Body Site

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1997599
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass
C15313
Was there a deviation from protocol therapy?
Description

Dose Modification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
please describe [deviation from protocol therapy]
Description

DoseModificationText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
Patient status
Description

Patient status

Life status at end of this course
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
C25365
Was patient confirmed lost to follow up at the end of this course?
Description

PatientLostFollow-upInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25560
UMLS 2011AA Property
C0745777
NCI Thesaurus Property-2
C16033
UMLS 2011AA Property-2
C1522577
Was patient enrolled on another COG therapeutic study at the end of this course?
Description

PatientOtherEnrollmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Was patient's consent withdrawn?
Description

PatientWithdrawFollow-upConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25460
NCI Thesaurus Property-3
C38061
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1707492
Was there a dose reduction this course as compared to the previous course?
Description

TreatmentReducedCourseInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
please explain why [dose reduction]
Description

TreatmentReducedCourseReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Did a second malignant neoplasm (SMN) occur during this course?
Description

NewCancerDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C25586
NCI Thesaurus ObjectClass-2
C9305
NCI Thesaurus Property
C15220
UMLS CUI-1
C0085183
Date SMN diagnosed
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property
C15220
UMLS CUI-1
C0085183
UMLS CUI-2
C0011008
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Category
Description

Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25161
UMLS CUI-1
C0877248
UMLS CUI-2
C0008902
CTC Adverse Event Reported Term
Description

CTC Adverse Event Reported Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25161
UMLS CUI-1
C1516728
UMLS CUI-2
C2699044
Type
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C45559
UMLS CUI-1
C1516728
UMLS CUI-2
C2826934
Code
Description

Code

Data type

text

Alias
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C45559
UMLS CUI-1
C1516728
UMLS CUI-2
C1705313
CTCAdverseEventCOGCodeSpecify
Description

CTCAdverseEventCOGCodeSpecify

Data type

text

Alias
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C41331
Grade
Description

CTCAdverseEventGrade2

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Attribution
Description

Attribution

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
UMLS CUI-1
C1706735
Adverse Drug Experience?
Description

ADRFiledInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C25410
NCI Thesaurus Property
C25175
UMLS CUI-1
C1521800
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1 forms
  1. StudyEvent: ANBL0321: End of Course Worksheet
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol ID COG
Item
Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
PatientCOGIdentifierNumber
Item
COG Number
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)
C39353 (NCI Thesaurus Property-2)
C1516477 (UMLS 2011AA Property-2)
Patient Name
Item
Patient Name
text
C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Form Completion Date
Item
Today's date
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
DataEnteredDate
Item
Date worksheet entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Research Comments
Item
Comments regarding this patient's course of therapy
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
TreatmentCurrentCourseNumber
Item
Course number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
Chemotherapy Cycle Start Date
Item
Course start date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
Chemotherapy Cycle End Date
Item
Course end date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0806020 (UMLS CUI-2)
AST/ALT Skin toxicity triglycerides calcium or creatinine abnormal
Item
did the patient have any of the following results: AST/ALT>2.5 times normal; Skin toxicity>Grade 1; Serum triglycerides>300mg/dL; Serum calcium>11.6mg/dL; No hematuria and/or proteinuria<1+ on urinalysis; Age adjusted abnormal serum creatinine
boolean
Agent
Item
agent name
text
C25364 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C1521826 (UMLS CUI-1)
Units
Item
agent UOM
text
C1708 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS CUI-1)
Agent Total Dose
Item
Total mg dose of Fenretinide received during this course
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Chemotherapy delayed
Item
Was there a delay in giving treatment during this course?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1299577 (UMLS CUI-1)
C25477 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
TreatmentDelayedReasonText
Item
why was there a delay?
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
PatientOff-treatmentInd-3
Item
Is patient off protocol therapy at the end of this course?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
Date Last Dose
Item
date last Fenretinide was received
date
C25164 (NCI Thesaurus ValueDomain)
C1762893 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
Item
reason off protocol therapy
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
C0566251 (UMLS CUI-2)
CL.4
Code List
reason off protocol therapy
CL Item
Progressive disease (Progressive disease)
CL Item
Patient/parent withdrawal from therapy (Patient/parent withdrawal from therapy)
CL Item
Completion of planned therapy or 30 courses (Completion of planned therapy or 30 courses)
CL Item
Adverse Event/side Effects/complications (Same Grade 3 or 4 toxicities recur after two dose reductions)
CL Item
Occurrence of pseudotumor cerebri (Occurrence of pseudotumor cerebri)
CL Item
If the sole measurable tumor lesion must be irradiated in order to provide symptom relief (If the sole measurable tumor lesion must be irradiated in order to provide symptom relief)
CL Item
Failure to respond (Failure to respond)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Lost To Follow-up (Lost to follow-up)
CL310949 (NCI Metathesaurus)
CL Item
Death On Study (Death on study)
CL Item
Cytogenetic Resistance (Cytogenetic Resistance)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Disease Progression Before Active Treatment (Disease Progression before Active Treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
What tests were done to document response?
text
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
CL.5
Code List
What tests were done to document response?
CL Item
Ct Scan (CT)
CL Item
Mri (MRI)
CL Item
Mibg (MIBG scan)
CL Item
Bone Marrow Morphology (Bone marrow morphology)
CL Item
Bone Marrow Immunocytology (Bone marrow immunocytology)
CL Item
Urine Hva/vma (Urine catechols)
CL Item
Other, Specify (Other, specify)
Item
Did the patient achieve a response?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25755 (NCI Thesaurus ValueDomain-2)
C0871261 (UMLS 2011AA ValueDomain-2)
CL.6
Code List
Did the patient achieve a response?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Not evaluated this course)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
what type of response was achieved?
text
CL.7
Code List
what type of response was achieved?
CL Item
Complete Response (Complete Response)
CL Item
Very Good Partial Response (Very Good Partial Response)
CL Item
Partial Response (Partial Response)
CL Item
Insufficient evaluation to determine response status (Insufficient evaluation to determine response status)
CL Item
SD (SD)
CL Item
Incomplete response/SD (Incomplete response/SD)
Item
what type of response was achieved? (For MIBG positive lesions:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
CL.9
Code List
what type of response was achieved? (For MIBG positive lesions:)
CL Item
Complete MIBG Response (Complete MIBG Response)
CL Item
Partial MIBG Response (Partial MIBG Response)
CL Item
Complete Response (CR)
CL Item
Death Prior To Completion Of Protocol Criteria (Early death)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Incomplete Response Or Stable Disesase (Incomplete response/SD)
ResponseConfirmedDate
Item
what was the date of response?
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
Item
What is the patient's overall response?
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass-2)
C1561607 (UMLS 2011AA ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
CL.10
Code List
What is the patient's overall response?
CL Item
Complete Response (Complete Response)
CL Item
Very Good Partial Response (Very Good Partial Response)
CL Item
Partial Response (Partial Response)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (Stable Disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (Progressive Disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Incomplete Response Or Stable Disesase (Incomplete response/SD)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status)
CL Item
Death Prior To Completion Of Protocol Criteria (Early death)
RTTreatmentInd-3
Item
Did patient receive radiation therapy during this course?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
Radiation Therapy Body Site
Item
specify sites [of RT]
text
C25191 (NCI Thesaurus ValueDomain)
C1997599 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C15313 (NCI Thesaurus ObjectClass)
Item
Was there a deviation from protocol therapy?
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.12
Code List
Was there a deviation from protocol therapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, protocol specified modification for toxicity)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, non-protocol specified modification for toxicity)
CL Item
Yes, other reason for deviation (Yes, other reason for deviation)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DoseModificationText
Item
please describe [deviation from protocol therapy]
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item Group
Item
Life status at end of this course
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)
CL.14
Code List
Life status at end of this course
CL Item
Alive (Alive)
CL Item
Dead (Dead)
PatientLostFollow-upInd-2
Item
Was patient confirmed lost to follow up at the end of this course?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25560 (NCI Thesaurus Property)
C0745777 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)
PatientOtherEnrollmentInd-2
Item
Was patient enrolled on another COG therapeutic study at the end of this course?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Consent Withdrawn
Item
Was patient's consent withdrawn?
boolean
C16960 (NCI Thesaurus ObjectClass)
C16033 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C38061 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1707492 (UMLS CUI-1)
TreatmentReducedCourseInd-2
Item
Was there a dose reduction this course as compared to the previous course?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
TreatmentReducedCourseReason
Item
please explain why [dose reduction]
text
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
Second malignant neoplasm
Item
Did a second malignant neoplasm (SMN) occur during this course?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0085183 (UMLS CUI-1)
SMN date
Item
Date SMN diagnosed
date
C25164 (NCI Thesaurus ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C0085183 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Item Group
C0877248 (UMLS CUI-1)
Item
Category
text
C25372 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C25161 (NCI Thesaurus Property)
C0877248 (UMLS CUI-1)
C0008902 (UMLS CUI-2)
CL.19
Code List
Category
CL Item
Dermatology/skin (Dermatology/Skin)
CL Item
Gastrointestinal (Gastrointestinal)
C13359 (NCI Thesaurus)
C0521362 (UMLS 2011AA)
CL Item
Hemorrhage/bleeding (Hemorrhage)
CL Item
Hepatobiliary/pancreas (Hepatic)
CL Item
Metabolic/laboratory (Metabolic/Laboratory)
CL Item
Ocular/visual (Ocular/Visual)
CL Item
Pain (Pain)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
CL Item
Unnamed Value [specify Category] (Unnamed Value [specify Category])
CTC Adverse Event Reported Term
Item
text
C25685 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C25161 (NCI Thesaurus Property)
C1516728 (UMLS CUI-1)
C2699044 (UMLS CUI-2)
Item
Type
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CL.20
Code List
Type
CL Item
Dry Skin (Dry Skin)
C0151908 (NCI Metathesaurus)
CL Item
Dermatitis Exfoliative Nos (Rash/Desquamation)
CL Item
Constipation (Constipation)
C37930 (NCI Thesaurus)
C0009806 (UMLS 2011AA)
CL Item
Diarrhoea Nos (Diarrhea without colostomy)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting Nos (Vomiting)
CL Item
Hemorrhage, Gu (Hematuria (in the absence of vaginal bleeding))
CL Item
Blood Alkaline Phosphatase Nos Increased (Alkaline Phosphatase)
CL Item
Aspartate Aminotransferase Increased (AST (SGOT))
C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)
CL Item
Alanine Aminotransferase Increased (ALT (SGPT))
C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)
CL Item
Blood Bilirubin Increased (Bilirubin)
CL039714 (NCI Metathesaurus)
CL Item
Hyperglycaemia Nos (Hyperglycemia)
CL Item
Hypertriglyceridaemia (Hyper-triglyceridemia)
C0020557 (NCI Metathesaurus)
CL Item
Dry Eye Nec (Dry eyes)
CL Item
Blindness Night (Vision- Night Blindness (nyctalopia))
CL Item
Abdominal Pain Nos (Abdominal pain/Cramping)
CL Item
Headache Nos (Headache)
CL Item
Unnamed Value [specify Type] (Unnamed Value [specify Type])
CTC Adverse Event Term
Item
text
C25685 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C45559 (NCI Thesaurus Property)
C1516728 (UMLS CUI-1)
C2826934 (UMLS CUI-2)
Item
Code
text
C49704 (NCI Thesaurus ObjectClass)
C45559 (NCI Thesaurus Property)
C1516728 (UMLS CUI-1)
C1705313 (UMLS CUI-2)
CL.21
Code List
Code
CL Item
298 (298)
CL Item
324 (324)
CL Item
371 (371)
CL Item
374 (374)
CL Item
Nausea (408)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting (426)
C3442 (NCI Thesaurus)
C0042963 (UMLS 2011AA)
CL Item
442 (442)
CL Item
462 (462)
CL Item
Sgot (ast) (481)
CL Item
Sgpt (alt) (482)
CL Item
464 (464)
CL Item
538 (538)
CL Item
548 (548)
CL Item
666 (666)
CL Item
686 (686)
CL Item
702 (702)
CL Item
716 (716)
CL Item
specify Code (specify Code)
CTCAdverseEventCOGCodeSpecify
Item
text
C25364 (NCI Thesaurus Property)
C41331 (NCI Thesaurus ObjectClass)
CTCAdverseEventGrade2
Item
Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Attribution
text
C25664 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
C1706735 (UMLS CUI-1)
CL.23
Code List
Attribution
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS CUI-1)
CL Item
Unlikely (Unlikely)
C0750558 (UMLS CUI-1)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
C0332149 (UMLS CUI-1)
CL Item
Probable (Probably)
C0332148 (NCI Metathesaurus)
C1709683 (UMLS CUI-1)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
C1704787 (UMLS CUI-1)
Adverse Drug Experience
Item
Adverse Drug Experience?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25410 (NCI Thesaurus ObjectClass)
C25175 (NCI Thesaurus Property)
C1521800 (UMLS CUI-1)
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