ID

10052

Description

ADVL0212: Reporting Period Worksheet FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia NCT00053963 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC15B1-1989-311F-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC15B1-1989-311F-E034-0003BA12F5E7

Keywords

Versions (6)
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 3/22/15 3/22/15 - Martin Dugas
  6. 3/22/15 3/22/15 - Martin Dugas
Uploaded on

March 22, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Recurring cancer children (ADVL0212 NCT00053963)

English

No Instruction available.

1 forms  
  1. StudyEvent: ADVL0212: Reporting Period Worksheet
    1. No Instruction available.
Header
Description

Header

Alias
UMLS CUI-1
C1320722
Reporting Period (1. Required field)
Description

TreatmentReportingPeriodNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
Reporting Period start date (1. Required field)
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
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
Institution 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
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C39353
UMLS CUI-1
C2348585
Patient's Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
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
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Patient characteristics
Description

Patient characteristics

Alias
UMLS CUI-1
C0815172
Patient's Height (in cm at beginning of Reporting Period)
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Patient's Weight (in kg at beginning of Reporting Period)
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
Did patient have a bone marrow evaluation during this reporting interval? (1. Required field)
Description

BoneMarrowEvaluationInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
what was the date of exam? (MM/DD/YYYY)
Description

BoneMarrowEvaluationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
does patient have bone marrow involvement? (Reset)
Description

BoneMarrowInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
Was patient's shortening fraction determined by echocardiogram?
Description

ShorteningFractionEchocardiogramAssessedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C25217
UMLS CUI-1
C0013516
what is the percentage? (1. Required field)
Description

ShorteningFractionResultPercentageValue

Data type

float

Alias
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C38020
UMLS CUI-1
C1335957
Was patient's ejection fraction as determined by MUGA?
Description

EjectionFractionRadionuclideVentriculogramScanAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C25217
NCI Thesaurus Property-2
C38073
NCI Thesaurus ObjectClass
C37946
UMLS CUI-1
C2700377
UMLS CUI-2
C0521317
EF: what is the percentage?
Description

EjectionFractionResultPercentageValue

Data type

float

Alias
NCI Thesaurus Property
C20200
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI-1
C0232174
Is patient off protocol therapy at the end of this reporting period? (1. Required field)
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 drug or other protocol defined treatment was received (1. Must be between DT1 and DT2 or entry is prevented)
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 (Off Study is defined as lost to follow-up, death, entry onto another COG therapeutic protocol)
Description

Off Treatment Reason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS CUI-1
C1518544
NCI Thesaurus Property
C25365
UMLS CUI-2
C0566251
Was patient's disease status evaluated during this reporting interval? (1. Required field)
Description

DiseaseExaminedDiseaseResponseInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C25500
NCI Thesaurus ObjectClass
C2991
UMLS CUI-1
C1516048
what was the patient's response? (1. If CR or PR, a request for submission of the response assessment form is generated if the form has not been filled out.)
Description

TumorResponseType

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25755
UMLS CUI-1
C3539879
Total mg dose of Depsipeptide received during this reporting period (1. Required field)
Description

Total mg dose of Depsipeptide received during this reporting period (1. Required field)

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 any of the infusions of Depsipeptide interrupted for any reason? (1. Required field)
Description

DoseInterruptionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C25488
NCI Thesaurus Property
C25542
UMLS CUI-1
C0558681
please describe. (1. Text field)
Description

DoseModificationText

Data type

text

Alias
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
Was there a deviation from protocol therapy? (1. Required field)
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
Did the patient receive radiation therapy during this reporting period? (1. Required field)
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 (1. If the field is reported as "Yes" above, some text must be filled in for the "specify sites" question. If above is no, this question must not be answered.)
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 tumor tissue surgically obtained for biology studies (e.g. biopsy, resection, fine needle aspiration)? (1. Required field)
Description

TissueBiologicalSourceSurgicalInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus Property
C25683
UMLS 2011AA Property
C0449416
Did a second malignant neoplasm (SMN) occur during this Reporting Period? (If SMN is acute myelogenous leukemia or myelodysplastic syndrome MDS, submit the NCI secondary AML/MDS form, cytogenetics and pathology reports.)
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 (1. If the answer to SMN is yes, this field must be supplied. The date must be between the start and end date of this reporting period.)
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Did patient receive concomitant medications while on protocol therapy? (1. Required field)
Description

ConcomitantMedicationReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
Type (Type of drugs)
Description

ConcomitantMedicationReceivedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
please list type (text field)
Description

ConcomitantMedicationUseSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Start Date
Description

Treatment Begin Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25431
UMLS CUI-1
C3173309
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
End Date
Description

Treatment End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1531784
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25275
Description (agent, dose, etc.)
Description

ConcomitantMedicationReceivedText

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
Reason for Administration
Description

Concomitant Medication Use Indication

Data type

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS CUI-1
C2826696
NCI Thesaurus ObjectClass-2
C25730
NCI Thesaurus Property
C25382
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25638
Patient status
Description

Patient status

Alias
UMLS CUI-1
C0449437
Life status at end of this reporting period (1. Required field)
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 reporting period? (1. Required field)
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 reporting period? (1. Required field)
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? (1. Required field)
Description

PatientWithdrawFollow-upConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus Property-3
C38061
UMLS 2011AA Property-3
C2349954
Did patient relapse or experience disease progression during this reporting period? (1. Required field)
Description

DiseaseProgressionInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
date of relapse or progression (MM/DD/YYYY)
Description

DiseaseProgressionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Category
Description

CTCAdverseEventCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
Other, specify
Description

Other, specify

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 ObjectClass
C41331
UMLS CUI-1
C1516728
NCI Thesaurus Property
C25703
UMLS CUI-2
C2826934
Other, specify
Description

CTCAdverseEventTermSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus Property
C25703
UMLS CUI-1
C1516728
UMLS CUI-2
C2826934
Code
Description

CommonTerminologyCriteriaAdverseEventTermCOGCode

Data type

text

Alias
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C45559
UMLS CUI-1
C1516728
UMLS CUI-2
C1705313
Other, specify
Description

Other, specify

Data type

text

Alias
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C41331
UMLS CUI-1
C0877248
Grade
Description

CTCAdverseEventGrade2

Data type

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Attribution (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Adverse Drug Experience? (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
Description

ADRFiledInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25410
UMLS 2011AA ObjectClass
C1521800
NCI Thesaurus Property
C25175
UMLS 2011AA Property
C1522646
Dose Limiting Toxicity? (Reset)
Description

ToxicityReportInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C27990
UMLS 2011AA ObjectClass
C0600688
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
Date Onset
Description

CTCAdverseEventOnsetDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Date of test or evaluation showing toxicity resolved to eligibility requirements or baseline
Description

Adverse Event Resolution Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985918
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25655
check box if not resolved [toxicity]
Description

CTCAdverseEventResolutionInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25655
UMLS 2011AA Property
C1514893
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1 forms
  1. StudyEvent: ADVL0212: Reporting Period Worksheet
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
TreatmentReportingPeriodNumber
Item
Reporting Period (1. Required field)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
Reporting Period Start Date
Item
Reporting Period start date (1. Required field)
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)
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
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Patient ID COG
Item
COG Number
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C39353 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
Patient Initials
Item
Patient's Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Patient characteristics
C0815172 (UMLS CUI-1)
Patient Height
Item
Patient's Height (in cm at beginning of Reporting Period)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Patient's Weight (in kg at beginning of Reporting Period)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
BoneMarrowEvaluationInd-3
Item
Did patient have a bone marrow evaluation during this reporting interval? (1. Required field)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
BoneMarrowEvaluationDate
Item
what was the date of exam? (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
BoneMarrowInvolvementInd-3
Item
does patient have bone marrow involvement? (Reset)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
EF by echocardiogram
Item
Was patient's shortening fraction determined by echocardiogram?
boolean
C38147 (NCI Thesaurus ValueDomain)
C25217 (NCI Thesaurus Property)
C0013516 (UMLS CUI-1)
Shortening fraction
Item
what is the percentage? (1. Required field)
float
C20200 (NCI Thesaurus Property)
C38020 (NCI Thesaurus ObjectClass)
C1335957 (UMLS CUI-1)
EF by MUGA
Item
Was patient's ejection fraction as determined by MUGA?
boolean
C38147 (NCI Thesaurus ValueDomain)
C25217 (NCI Thesaurus Property)
C38073 (NCI Thesaurus Property-2)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS CUI-1)
C0521317 (UMLS CUI-2)
EF
Item
EF: what is the percentage?
float
C20200 (NCI Thesaurus Property)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0232174 (UMLS CUI-1)
PatientOff-treatmentInd-3
Item
Is patient off protocol therapy at the end of this reporting period? (1. Required field)
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 drug or other protocol defined treatment was received (1. Must be between DT1 and DT2 or entry is prevented)
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 (Off Study is defined as lost to follow-up, death, entry onto another COG therapeutic protocol)
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
C0566251 (UMLS CUI-2)
CL.6
Code List
reason off protocol therapy (Off Study is defined as lost to follow-up, death, entry onto another COG therapeutic protocol)
CL Item
Relapse/Progressive disease (Relapse/Progressive disease)
CL Item
Adverse Event/side Effects/complications (Irreversible dose-limiting toxicity)
CL Item
Patient withdrawal from protocol (Patient withdrawal from protocol)
CL Item
Off Study (Off Study)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during 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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression Before Active Treatment (Disease Progression before Active Treatment)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal or refusal before beginning protocol therapy)
CL Item
Lost To Follow-up (Lost to follow-up)
CL310949 (NCI Metathesaurus)
CL Item
Cytogenetic Resistance (Cytogenetic Resistance)
assessment
Item
Was patient's disease status evaluated during this reporting interval? (1. Required field)
boolean
C38147 (NCI Thesaurus ValueDomain)
C25500 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C1516048 (UMLS CUI-1)
Item
what was the patient's response? (1. If CR or PR, a request for submission of the response assessment form is generated if the form has not been filled out.)
integer
C25284 (NCI Thesaurus ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C3539879 (UMLS CUI-1)
CL.8
Code List
what was the patient's response? (1. If CR or PR, a request for submission of the response assessment form is generated if the form has not been filled out.)
CL Item
Complete Response (1)
C0677874 (UMLS CUI-1)
CL Item
Partial Response (2)
C1521726 (UMLS CUI-1)
CL Item
Stable disease (3)
C0677946 (UMLS CUI-1)
CL Item
Progressive Disease (4)
C1335499 (UMLS CUI-1)
CL Item
Not evaluable (5)
C1883425 (UMLS CUI-1)
Agent Total Dose
Item
Total mg dose of Depsipeptide received during this reporting period (1. Required field)
float
C25304 (NCI Thesaurus ValueDomain)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C2986497 (UMLS CUI-1)
Drug therapy discontinued
Item
Were any of the infusions of Depsipeptide interrupted for any reason? (1. Required field)
boolean
C38148 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C25542 (NCI Thesaurus Property)
C0558681 (UMLS CUI-1)
DoseModificationText
Item
please describe. (1. Text field)
text
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Was there a deviation from protocol therapy? (1. Required field)
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? (1. Required field)
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)
RTTreatmentInd-3
Item
Did the patient receive radiation therapy during this reporting period? (1. Required field)
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 (1. If the field is reported as "Yes" above, some text must be filled in for the "specify sites" question. If above is no, this question must not be answered.)
text
C25191 (NCI Thesaurus ValueDomain)
C1997599 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C15313 (NCI Thesaurus ObjectClass)
TissueBiologicalSourceSurgicalInd-2
Item
Was tumor tissue surgically obtained for biology studies (e.g. biopsy, resection, fine needle aspiration)? (1. Required field)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C25683 (NCI Thesaurus Property)
C0449416 (UMLS 2011AA Property)
Second malignant neoplasm
Item
Did a second malignant neoplasm (SMN) occur during this Reporting Period? (If SMN is acute myelogenous leukemia or myelodysplastic syndrome MDS, submit the NCI secondary AML/MDS form, cytogenetics and pathology reports.)
boolean
C38148 (NCI Thesaurus ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0085183 (UMLS CUI-1)
NewCancerDiagnosisDate
Item
Date SMN diagnosed (1. If the answer to SMN is yes, this field must be supplied. The date must be between the start and end date of this reporting period.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
ConcomitantMedicationReceivedInd-2
Item
Did patient receive concomitant medications while on protocol therapy? (1. Required field)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
Item
Type (Type of drugs)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL.14
Code List
Type (Type of drugs)
CL Item
Corticosteroid (Corticosteroid)
C2322 (NCI Thesaurus)
C0001617 (UMLS 2011AA)
CL Item
Anti-convulsant (Anti-Convulsant)
CL Item
Anti-fungal (Anti-Fungal)
C0718566 (NCI Metathesaurus)
CL Item
Growth Factor (Growth factor)
C20424 (NCI Thesaurus)
C0018284 (UMLS 2011AA)
CL Item
Other Specify (Other, specify)
ConcomitantMedicationUseSpecify
Item
please list type (text field)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Treatment Begin Date
Item
Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Treatment End Date
Item
End Date
date
C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
ConcomitantMedicationReceivedText
Item
Description (agent, dose, etc.)
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
Concomitant Medication Use Indication
Item
Reason for Administration
text
C459 (NCI Thesaurus ObjectClass)
C2826696 (UMLS CUI-1)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C25638 (NCI Thesaurus ValueDomain-2)
Item Group
Patient status
C0449437 (UMLS CUI-1)
Item
Life status at end of this reporting period (1. Required field)
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)
CL.16
Code List
Life status at end of this reporting period (1. Required field)
CL Item
Alive (Alive)
CL Item
Dead (Dead)
PatientLostFollow-upInd-2
Item
Was patient confirmed lost to follow up at the end of this reporting period? (1. Required field)
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 reporting period? (1. Required field)
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)
PatientWithdrawFollow-upConsentInd-2
Item
Was patient's consent withdrawn? (1. Required field)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C38061 (NCI Thesaurus Property-3)
C2349954 (UMLS 2011AA Property-3)
DiseaseProgressionInd-3
Item
Did patient relapse or experience disease progression during this reporting period? (1. Required field)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
DiseaseProgressionDate
Item
date of relapse or progression (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
Category
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CL.21
Code List
Category
CL Item
Gastrointestinal (Gastrointestinal)
C13359 (NCI Thesaurus)
C0521362 (UMLS 2011AA)
CL Item
Infection Febrile Neutropenia (Infection/Febrile Neutropenia)
CL Item
Blood/bone Marrow (Blood/Bone Marrow)
CL324677 (NCI Metathesaurus)
CL Item
Hepatic (Hepatic)
C13308 (NCI Thesaurus)
C0205054 (UMLS 2011AA)
CL Item
Renal/genitourinary (Renal/Genitourinary)
CL328688 (NCI Metathesaurus)
CL Item
Cardiovascular (arrhythmia) (Cardiovascular (Arrhythmia))
CL Item
Constitutional Symptoms (Constitutional Symptoms)
CL Item
Metabolic/laboratory (Metabolic/Laboratory)
CL Item
Other, specify [unnamed category] (Other, specify [unnamed category])
CTC Adverse Event Reported Term
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C25161 (NCI Thesaurus Property)
C1516728 (UMLS CUI-1)
C2699044 (UMLS CUI-2)
Item
Type
text
C41331 (NCI Thesaurus ObjectClass)
C1516728 (UMLS CUI-1)
C25703 (NCI Thesaurus Property)
C2826934 (UMLS CUI-2)
CL.22
Code List
Type
CL Item
Nausea (Nausea)
CL Item
Vomiting Nos (Vomiting)
CL Item
Not Available (Febrile Neutropenia)
CL Item
Neutropenia (Neutrophils/Granulocytes (ANC/AGC))
CL Item
Aspartate Aminotransferase Increased (SGOT (AST))
C26947 (NCI Thesaurus)
C0151904 (UMLS 2011AA)
CL Item
Alanine Aminotransferase Increased (SGPT (ALT))
C26948 (NCI Thesaurus)
C0151905 (UMLS 2011AA)
CL Item
Blood Creatinine Increased (Creatinine)
C0235431 (NCI Metathesaurus)
CL Item
Platelet Count Decreased (Platelets)
CL Item
Arrhythmia Nos (Ventricular Arrhythmia)
CL Item
Fatigue (Fatigue)
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Blood Creatine Phosphokinase Increased (CPK)
CL038686 (NCI Metathesaurus)
CL Item
Other, specify [unnamed type] (Other, specify [unnamed type])
CTC Adverse Event Term
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C25703 (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.23
Code List
Code
CL Item
Nausea (408)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Vomiting (426)
C3442 (NCI Thesaurus)
C0042963 (UMLS 2011AA)
CL Item
Febrile Neutropenia (494)
C0746883 (NCI Metathesaurus)
CL Item
Neutrophils/granulocytes (anc/agc) (146)
CL Item
Sgot (ast) (481)
CL Item
Sgpt (alt) (482)
CL Item
Creatinine (784)
CL Item
Platelets (148)
CL Item
Ventricular Arrhythmia Nos (181)
CL Item
Fatigue (262)
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Creatinine Phosphokinase (cpk) (532)
CL Item
Other, Specify (Other, specify [unnamed code])
CTCAdverseEventCOGCodeSpecify
Item
Other, specify
text
C25364 (NCI Thesaurus Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS CUI-1)
CTCAdverseEventGrade2
Item
Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Attribution (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.25
Code List
Attribution (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
ADRFiledInd-3
Item
Adverse Drug Experience? (Code only for grade 2 or higher or for any toxicity for which an AdEERS Report is filed)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25410 (NCI Thesaurus ObjectClass)
C1521800 (UMLS 2011AA ObjectClass)
C25175 (NCI Thesaurus Property)
C1522646 (UMLS 2011AA Property)
ToxicityReportInd-2
Item
Dose Limiting Toxicity? (Reset)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C27990 (NCI Thesaurus ObjectClass)
C0600688 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
CTCAdverseEventOnsetDate
Item
Date Onset
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
Adverse Event Resolution Date
Item
Date of test or evaluation showing toxicity resolved to eligibility requirements or baseline
date
C25164 (NCI Thesaurus ValueDomain)
C2985918 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25655 (NCI Thesaurus Property)
CTCAdverseEventResolutionInd
Item
check box if not resolved [toxicity]
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25655 (NCI Thesaurus Property)
C1514893 (UMLS 2011AA Property)
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