ID

43379

Beschreibung

ANHL01P1: Reporting Period Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma NCT00057811 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BA568824-31F6-08D7-E034-0003BA12F5E7

Link

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

Stichworte

Lymphom

Klinische Studie [Dokumenttyp]

Leukämie, B-Zell-

Verlaufsstudien

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Advanced B-Cell Leukemia or Lymphoma (NCT00057811)

Modell
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1 Formulare

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

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header

Item Group

Header

C1320722 (UMLS CUI-1)

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)

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 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)

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)

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)

day number

Item

day number

integer

C25301 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain-2)
C1547352 (UMLS CUI-1)

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 characteristics

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)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS CUI-1)

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)

assessment

Item

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

boolean

C38147 (NCI Thesaurus ValueDomain)
C25500 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C1516048 (UMLS CUI-1)

Response

Item

COP Phase (Required only for Reduction Phase)

text

C25284 (NCI Thesaurus ValueDomain)
C25755 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C3161 (NCI Thesaurus ObjectClass-2)
C1704632 (UMLS CUI-1)

CL.16

Code List

COP Phase (Required only for Reduction Phase)

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)

CL Item

20% tumor reduction (>)

Bone marrow

Item

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

boolean

C38148 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS CUI-1)

Reason no bone marrow

Item

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

text

C25214 (NCI Thesaurus Property)
C12431 (NCI Thesaurus ObjectClass)

Bone marrow date

Item

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

date

C25164 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS CUI-1)
C0011008 (UMLS CUI-2)

Bone Marrow Involvement

Item

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

boolean

C38148 (NCI Thesaurus ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C25548 (NCI Thesaurus Property)
C1517677 (UMLS CUI-1)

Blasts, Bone Marrow

Item

percent (%) malignant blasts in bone marrow

float

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

CNS involvement

Item Group

CNS involvement

C0449389 (UMLS CUI-1)

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)
C3714787 (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)
C3714787 (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)

Erythrocyte

Item

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

float

C25294 (NCI Thesaurus ObjectClass)
C12521 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0014772 (UMLS CUI-1)

Blasts

Item

Blasts present in cytocentrifuge (Required if CNS involvement yes)

float

C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0523113 (UMLS CUI-1)

Total number of cells

Item

total number of cells counted

float

C19157 (NCI Thesaurus ObjectClass)
C12508 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0427872 (UMLS CUI-1)

Diagnostics and treatment

Item Group

Diagnostics and treatment

Echocardiogram

Item

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

boolean

C38147 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C0013516 (UMLS CUI-1)

Imaging studies

Item

Imaging Studies Following Reporting Period (Required field)

integer

C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C0011923 (UMLS CUI-1)

CL.12

Code List

Imaging Studies Following Reporting Period (Required field)

CL Item

Chest X-ray (1)

C0039985 (UMLS CUI-1)

CL Item

Abdominal Ultrasound (2)

C2348813 (UMLS CUI-1)

CL Item

Abdominal CT or MRI (3)

CL Item

Bone Scan (4)

C0203668 (UMLS CUI-1)

CL Item

PET Scan (5)

C0032743 (UMLS CUI-1)

CL Item

Gallium Scan (6)

C0521316 (UMLS CUI-1)

CL Item

Head or spine CT or MRI (7)

CL Item

Testicular ultrasound (8)

Imaging finding

Item

results of imaging studies

integer

C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C1287399 (UMLS CUI-1)

CL.13

Code List

results of imaging studies

CL Item

Evidence of disease (1)

C0332120 (UMLS CUI-1)

CL Item

No evidence of disease (2)

C1518340 (UMLS CUI-1)

CL Item

Equivocal (3)

C0332241 (UMLS CUI-1)

CL Item

Not done (4)

C1272696 (UMLS CUI-1)

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)

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 Assignment

Item

treatment assignment (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)

text

C25704 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25426 (NCI Thesaurus Property)
C1522541 (UMLS CUI-1)

CL.19

Code List

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)

Residual Tumor

Item

Was there evidence of residual disease on diagnostic tests?

integer

C25284 (NCI Thesaurus ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C37895 (NCI Thesaurus ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0543478 (UMLS CUI-1)

CL.20

Code List

Was there evidence of residual disease on diagnostic tests?

CL Item

Yes (1)

C1705108 (UMLS CUI-1)

CL Item

No (2)

C1298908 (UMLS CUI-1)

CL Item

Gross Disease (3)

C0267604 (UMLS CUI-1)

CL Item

Microscopic Disease (4)

C0278939 (UMLS CUI-1)

CL Item

Unknown/not Documented (5)

C0439673 (UMLS CUI-1)

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)

Biopsy Result

Item

what were the results? (If yes,)

text

C15189 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C0005558 (UMLS CUI-1)
C1274040 (UMLS CUI-2)

CL.13

Code List

what were the results? (If yes,)

CL Item

Evidence of disease (1)

C0332120 (UMLS CUI-1)

CL Item

No evidence of disease (2)

C1518340 (UMLS CUI-1)

CL Item

Equivocal (3)

C0332241 (UMLS CUI-1)

CL Item

Not done (4)

C1272696 (UMLS CUI-1)

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)

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)

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)

Dialysis

Item

type of renal support

integer

C37902 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C0011946 (UMLS CUI-1)

CL.29

Code List

type of renal support

CL Item

Hemodialysis (1)

C0019004 (UMLS CUI-1)

CL Item

Peritoneal dialysis (2)

C0031139 (UMLS CUI-1)

CL Item

CVVH (3)

C0472684 (UMLS CUI-1)

CL Item

CVAH (4)

C0007474 (UMLS CUI-1)

CL Item

Other, Specify (5)

C3844311 (UMLS CUI-1)

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)

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)

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,)

integer

C25301 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C25330 (NCI Thesaurus ValueDomain-2)
C0450442 (UMLS CUI-1)
C0449238 (UMLS CUI-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)

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)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)
C3846084 (UMLS CUI-1)

CL.35

Code List

Life status at end of this reporting period (Required field)

CL Item

Alive (Alive)

C2584946 (UMLS CUI-1)

CL Item

Dead (Dead)

C0011065 (UMLS CUI-1)

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)

Lab values

Item Group

Lab values

C2346633 (UMLS CUI-1)

uric acid

Item

uric acid level, 4 Hours Post-Treatment

float

C25225 (NCI Thesaurus ObjectClass)
C37984 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C0365228 (UMLS CUI-1)

Potassium

Item

Potassium

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C464 (NCI Thesaurus Property-2)
C765 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C0032821 (UMLS CUI-1)

Phosphate

Item

Phosphate

float

C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C64857 (NCI Thesaurus Property-2)
C0523826 (UMLS CUI-1)

Calcium

Item

Calcium

float

C25294 (NCI Thesaurus ObjectClass)
C331 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C0201925 (UMLS CUI-1)

Blood Urea Nitrogen

Item

BUN

float

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

Creatinine

Item

Creatinine

float

C25225 (NCI Thesaurus ObjectClass)
C399 (NCI Thesaurus Property)
C25294 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C0201976 (UMLS CUI-1)

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)

LDH elevated

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)
C16414 (NCI Thesaurus ObjectClass)
C0202113 (UMLS CUI-1)
C3163633 (UMLS CUI-2)

ANC

Item

ANC

float

C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0948762 (UMLS CUI-1)

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)

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Advanced B-Cell Leukemia or Lymphoma (NCT00057811)

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