ID

8714

Beskrivning

ANHL01P1: Reporting Period [reload] Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BA568824-31F6-08D7-E034-0003BA12F5E7

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BA568824-31F6-08D7-E034-0003BA12F5E7

Nyckelord

Lymphoma

D015448

Uppladdad den

9 januari 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Drug/Agent Toxicity by Tissue/Organ NCT00057811 Treatment - ANHL01P1: Reporting Period [reload] - 2091659v3.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: ANHL01P1: Reporting Period [reload]
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header

Item Group

Header

Institution Name

Item

Institution

text

C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)

Institution Name

Item

Institution

text

C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)

Protocol ID COG

Item

Study

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)

Patient Name

Item

Patient Name

text

C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
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)

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 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)

Unnamed2

Item Group

Unnamed2

TreatmentReportingPeriodNumber

Item

Reporting Period (Institution will choose which course their patient is on.)

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)

CL.1

Code List

Reporting Period (Institution will choose which course their patient is on.)

CL Item

Reduction Phase (Reduction Phase)

CL Item

Induction, 1st Cycle (Induction, 1st Cycle)

CL Item

Induction, 2nd cycle (Induction, 2nd cycle)

CL Item

Consolidation, 1st course (CYM-RM1) (Consolidation, 1st course (CYM-RM1))

CL Item

Consolidation, other than CYM-RM1 (Consolidation, other than CYM-RM1)

CL Item

Maintenance, Course 1 (Maintenance, Course 1)

CL Item

Maintenance, Course 2 (Maintenance, Course 2)

CL Item

Maintenance, Course 3 (Maintenance, Course 3)

CL Item

Maintenance, Course 4 (Maintenance, Course 4)

Reporting Period Start Date

Item

Reporting Period Start date (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 (Denote this field as "DT2")

date

C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)

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)

Unnamed3

Item Group

Unnamed3

Institution Name

Item

Institution

text

C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)

Protocol ID COG

Item

Study

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)

Patient Name

Item

Patient Name

text

C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

PatientCOGIdentifierNumber

Item

COG Number

text

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)

DataEnteredDate

Item

Date entered into RDE

date

Unnamed4

Item Group

Unnamed4

DiseaseExaminedDiseaseResponseInd-2

Item

Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

CL.2

Code List

Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

No (Not Done)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LeukemiaDiseaseResponseType

Item

COP Phase (Required only for Reduction Phase)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3161 (NCI Thesaurus ObjectClass-2)
C0023418 (UMLS 2011AA ObjectClass-2)

CL.16

Code List

COP Phase (Required only for Reduction Phase)

CL Item

>=20% tumor reduction (>=20% tumor reduction)

CL Item

<20% tumor reduction (<20% tumor reduction)

CL Item

Equivocal (Equivocal)

CL Item

Not done (Not done)

CL Item

Sub-Pilot B or Pilot B <20% reduction (Sub-Pilot B or Pilot B <20% reduction)

CL Item

Complete Response (CR)

CL Item

Incomplete Response Or Stable Disesase (Incomplete response/SD)

CL Item

Insufficient Evaluation (Insufficient evaluation to determine response status)

CL Item

Progression; At Least A 20% Increase In The Sum Of Ld Of Target Lesions Taking As References The Smallest Sum Ld Recorded Since The Treatment Started Or The Appearance Of One Or More New Lesions (PD)

CL Item

Partial Response (PR)

C18212 (NCI Thesaurus)

CL Item

Stable Disease (SD)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

BoneMarrowEvaluationInd-3

Item

Did the patient have a bone marrow evaluation during this reporting period? (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)

BoneMarrowNotEvaluationReason

Item

If bone marrow evaluation not done, specify reason (Required if above answer is not done)

text

C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)

BoneMarrowEvaluationDate

Item

what was the date of the exam? [bone marrow evaluation] (If yes,)

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 the patient have bone marrow involvement? (If yes,)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)

CL.6

Code List

does the patient have bone marrow involvement? (If yes,)

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)

Blasts, Bone Marrow

Item

percent (%) malignant blasts in bone marrow (Required field)

float

C25294 (NCI Thesaurus ObjectClass)
C1982687 (UMLS CUI-1)
C12431 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C12918 (NCI Thesaurus Property-3)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Unnamed5

Item Group

Unnamed5

CNSEvaluationReportingInd-2

Item

Was patient's CNS status evaluated during this reporting period? (Required field)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)

CNSInvolvedInd-3

Item

Does patient have CNS involvement? (Required if above answer is 'yes')

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CSFCellCountInd-3

Item

Was cerebrospinal fluid cell count done? (Required if CNS involvement yes)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)

CSFCellCountDate

Item

date CSF fluid cell count was done (If yes,)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)

Leukocytes (WBC)

Item

Number of white cells counted (Required if CNS involvement yes)

float

C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureErythrocyteResultSpecifiedValue

Item

Number of red cells counted (Required if CNS involvement yes)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12521 (NCI Thesaurus Property)
C0014792 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)

HematologyBlastsLabValue

Item

Blasts present in cytocentrifuge (Required if CNS involvement yes)

text

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

SpecimenCellCountInd-3

Item

Were total number of cells counted in the cytocentrifuge? (Required if CNS involvement yes)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)

SpecimenCellCountTotalValue

Item

total number of cells counted (If yes,)

float

C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property-2)
C1265611 (UMLS 2011AA Property-2)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

EchocardiogramAssessmentPerformedReportingInd-2

Item

was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

CL.11

Code List

was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

No (Not Done)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Unnamed6

Item Group

Unnamed6

ReportingAssessmentMethodType

Item

Imaging Studies Following Reporting Period (Required field)

text

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

CL.12

Code List

Imaging Studies Following Reporting Period (Required field)

CL Item

Chest X-ray, Pa And Lateral (Chest x-ray)

CL Item

Abdominal Ultrasound (Abdominal Ultrasound)

CL Item

Abdominal Ct Or Mri (Abdominal CT or MRI)

CL Item

Bone Scan (Bone Scan)

C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)

CL Item

Pet Scan (PET Scan)

CL Item

Gallium Scan (Gallium Scan)

C38087 (NCI Thesaurus)
C0521316 (UMLS 2011AA)

CL Item

Head Or Spine Ct Or Mri (Head or spine CT or MRI)

CL Item

Testicular Ultrasound (Testicular ultrasound)

AssessmentResultType

Item

Unnamed question [results of imaging studies]

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)

CL.13

Code List

Unnamed question [results of imaging studies]

CL Item

Evidence Of Disease (Evidence of disease)

CL Item

No Evidence Of Disease (No evidence of disease)

C40413 (NCI Thesaurus)
C1518340 (UMLS 2011AA)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

LeukemiaDiseaseResponseType

Item

COP Phase (Required only for Reduction Phase)

text

CL.16

Code List

COP Phase (Required only for Reduction Phase)

CL Item

>=20% tumor reduction (>=20% tumor reduction)

CL Item

<20% tumor reduction (<20% tumor reduction)

CL Item

Equivocal (Equivocal)

CL Item

Not done (Not done)

CL Item

Sub-Pilot B or Pilot B <20% reduction (Sub-Pilot B or Pilot B <20% reduction)

CL Item

Complete Response (CR)

CL Item

Incomplete Response Or Stable Disesase (Incomplete response/SD)

CL Item

Insufficient Evaluation (Insufficient evaluation to determine response status)

CL Item

Progression; At Least A 20% Increase In The Sum Of Ld Of Target Lesions Taking As References The Smallest Sum Ld Recorded Since The Treatment Started Or The Appearance Of One Or More New Lesions (PD)

CL Item

Partial Response (PR)

C18212 (NCI Thesaurus)

CL Item

Stable Disease (SD)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

PatientOff-treatmentInd-3

Item

Is the patient off protocol therapy at the end of this reporting period? (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 (If yes,)

date

C25164 (NCI Thesaurus ValueDomain)
C1762893 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)

Off Treatment Reason

Item

reason off protocol therapy (If yes,)

text

C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
C0566251 (UMLS CUI-2)

CL.15

Code List

reason off protocol therapy (If yes,)

CL Item

Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)

CL Item

Disease Progression Before Active Treatment (Disease progression/relapse during active treatment)

CL Item

Disease Progression, Relapse During Active Treatment (Group C patients who have biopsy proven residual disease after induction (COPADM2))

CL Item

Adverse Event/side Effects/complications (Toxicity/Side Effects/Complications)

CL Item

Death On Study (Death)

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 a protocol therapy)

CL Item

Alternative Therapy (Alternative therapy)

CL Item

Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)

CL Item

Cytogenetic Resistance (Cytogenetic resistance)

CL Item

Disease Progression Before Active Treatment (Disease progression before active treatment)

CL Item

Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient declared ineligible)

CL Item

Lost To Follow-up (Lost to follow-up)

CL310949 (NCI Metathesaurus)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

LDH

Item

LDH (Required field)

float

C20200 (NCI Thesaurus Property)
C0202113 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25184 (NCI Thesaurus Property-2)

LDH ULN

Item

Institutional upper limits of normal for LDH (Required field)

float

C25294 (NCI Thesaurus ObjectClass)
C0202113 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C25184 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)

ChemistryLDHLabElevatedValue

Item

If LDH level was elevate above institutional upper limits of normal,: ____ fold increase (Required only if LDH was elevated above institutional upper limits of normal)

float

C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C16414 (NCI Thesaurus ObjectClass)
C0007996 (UMLS 2011AA ObjectClass)

LaboratoryProcedureNeutrophilResultSpecifiedValue

Item

ANC (uL)

float

C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Platelets

Item

Platelets/uL (Required field)

float

C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

Treatment Modification

Item

was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1299575 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)

Treatment Modification

Item

was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1299575 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)

Treatment Modification

Item

was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1299575 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)

TreatmentAssignmentText

Item

Unnamed question [treatment assignment] (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)

CL.19

Code List

Unnamed question [treatment assignment] (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)

CL Item

CYM-RM1 (CYM-RM1)

CL Item

CYM-RM2 (CYM-RM2)

ResidualDiseaseStatusType

Item

Was there evidence of residual disease on diagnostic tests?

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37895 (NCI Thesaurus ObjectClass-2)
C1609982 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.20

Code List

Was there evidence of residual disease on diagnostic tests?

CL Item

Yes (Yes)

CL Item

No Evidence Of Disease (No)

C40413 (NCI Thesaurus)
C1518340 (UMLS 2011AA)

CL Item

Gross Disease (gross disease)

CL Item

Microscopic Disease (microscopic disease)

CL Item

Unknown/not Documented (unknown/not documented)

TumorBiopsyInd-3

Item

was a biopsy performed? (If yes,)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)

BiopsyResultType

Item

what were the results? (If yes,)

text

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)

CL.22

Code List

what were the results? (If yes,)

CL Item

Evidence Of Disease (Evidence of disease)

CL Item

No Evidence Of Disease (No evidence of disease)

C40413 (NCI Thesaurus)
C1518340 (UMLS 2011AA)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CTCAdverseEventLysisGrade

Item

Tumor lysis syndrome? (Required during reduction phase only)

float

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

Unnamed7

Item Group

Unnamed7

TreatmentDayCount

Item

Unnamed question [day number]

float

C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)

RenalUricAcidLabSpecifiedValue

Item

4 Hours Post-Treatment [uric acid level]

float

C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

Item

Potassium (mEq/L)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C765 (NCI Thesaurus Property-3)
C0032821 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedurePhosphateMeasurementResultSpecifiedValue

Item

Phosphate (mg/dL)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C64857 (NCI Thesaurus Property-2)
C0523826 (UMLS 2011AA Property-2)

ElectrolytesCalciumLabSpecifiedValue

Item

Calcium (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Blood Urea Nitrogen

Item

BUN (mg/dL)

float

C20200 (NCI Thesaurus Property)
C0005845 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C61019 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)

RenalCreatinineLabSpecifiedValue

Item

Creatinine (mg/dL)

float

C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Unnamed8

Item Group

Unnamed8

RenalAbnormalityInd-3

Item

Did renal dysfunction occur during the reduction phase? (Required for reduction phase only.)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)

Agent

Item

Unnamed question [agent name]

text

C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)

Agent

Item

Unnamed question [agent name]

text

C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)

Agent

Item

Unnamed question [agent name]

text

C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)

CTCAdverseEventRenalFailureGrade

Item

Maximal grade of renal dysfunction (Choose One)

float

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

RenalSupportAdministeredInd-2

Item

Was there assisted renal support?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

RenalSupportAdministeredType

Item

Unnamed question [type of renal support] (If yes for assisted renal support)

text

C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.29

Code List

Unnamed question [type of renal support] (If yes for assisted renal support)

CL Item

Hemodialysis (Hemodialysis)

C15248 (NCI Thesaurus)
C0019004 (UMLS 2011AA)

CL Item

Peritoneal Dialysis (Peritoneal dialysis)

C15297 (NCI Thesaurus)
C0031139 (UMLS 2011AA)

CL Item

Cvvh (CVVH)

CL Item

Cvah (CVAH)

CL Item

Other, Specify (Other (please specify below))

RenalSupportAdministeredSpecify

Item

please specify [type of renal support] (Text)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

AgentPriorAdministeredReportingInd-2

Item

Was rasburicase utilized prior to Day 0 of the reduction phase? (Required only for Reduction Phase)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

AgentAdministeredDayDuration

Item

number of days given prior to Day 0 (If yes,)

float

C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)

AgentCourseCount

Item

number of doses given prior to Day 0 (If yes,)

float

C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)

Unnamed9

Item Group

Unnamed9

TreatmentDayCount

Item

Unnamed question [day number]

float

C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)

RenalUricAcidLabSpecifiedValue

Item

4 Hours Post-Treatment [uric acid level]

float

RenalUricAcidLabSpecifiedValue

Item

4 Hours Post-Treatment [uric acid level]

float

Unnamed10

Item Group

Unnamed10

Agent

Item

Unnamed question [agent name]

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

Did the patient receive rituximab in this cycle?

boolean

C38147 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)

CTCAdverseEventStevens-JohnsonSyndromePresentInd-2

Item

did the patient develop clinically significant Steven's Johnson syndrome? (If yes,)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)

NewCancerDiagnosisInd-3

Item

Did a second malignant neoplasm (SMN) occur during this Reporting Period? (Required field)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

NewCancerDiagnosisDate

Item

Date SMN diagnosed (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)

Patient Status

Item

Life status at end of this reporting period (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.35

Code List

Life status at end of this reporting period (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? (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 the reporting period? (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

Did the patient withdraw consent for follow-up at the end of the reporting period? (Note: Withdrawal of consent is to be coded only when the patient no longer wants to participate in the study and asks that data no longer be submitted.)

boolean

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)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

DiseaseProgressionInd-3

Item

Did the patient relapse or experience disease progression during the reporting period? (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 (If yes,)

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)

CCRR MODULE

Item Group

Ccrr Module For Anhl01p1: Reporting Period [reload]

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Drug/Agent Toxicity by Tissue/Organ NCT00057811 Treatment - ANHL01P1: Reporting Period [reload] - 2091659v3.0

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