ID

328

Description

CALGB 50901 Eligibility Checklist Form Ofatumumab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9F9012C3-FDE5-DB91-E040-BB89AD432434

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9F9012C3-FDE5-DB91-E040-BB89AD432434

Keywords

Versions (3)
  1. 4/19/12 4/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
Uploaded on

April 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT01190449 Lymphoma - CALGB 50901 Eligibility Checklist Form 3211939_v1_0

German English

No Instruction available.

1 forms  
  1. StudyEvent: CALGB 50901 Eligibility Checklist Form
    1. No Instruction available.
Eligibility Checklist
Description

Eligibility Checklist

Hematopoietic Diagnosis (Mark one with an X. see Section 4.1.1 Histologically confirmed follicular lymphoma, WHO classification grade 1, 2, or 3a without histologic transformation that is stage III, IV or bulky stage II i.e., single mass >= 7 cm in any uni-dimensional measurement)
Description

LymphomaDiagnosisHematopoieticType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3208
UMLS 2011AA ObjectClass
C0024299
NCI Thesaurus ValueDomain
C13324
UMLS 2011AA ValueDomain
C0229601
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Modified Ann Arbor Stage (Mark one with an X. see Section 4.1.1)
Description

LymphomaAnnArborLymphomaStagingSystemClassificationStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3208
UMLS 2011AA ObjectClass
C0024299
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
Does institutional flow cytometry or immunohistochemistry confirm CD20 antigen expression (Tumor tissue must be confirmed to express the CD20 antigen by institutional flow cytometry or immunohistochemistry. see Section 4.1.2)
Description

LaboratoryProcedureT-LymphocyteCD20AntigenOutcomeInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12476
UMLS 2011AA Property
C0039194
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38896
UMLS 2011AA Property
C0054946
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Baseline Longest Diameter of Lesion (cm of the largest involved node Patient must have at least one site of measurable disease that is greater than 1 cm in diameter present either on physical exam or imaging studies. see Section 4.1.3 and 4.5)
Description

BaselineMalignantNeoplasmLongestDiameterMeasurement

Data type

double

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C25213
UMLS 2011AA ObjectClass
C1442488
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property
C25558
UMLS 2011AA Property
C1522425
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain
C25285
UMLS 2011AA ValueDomain
C1301886
cm
Any prior systemic therapy for NHL other than involved field radiation therapy (No prior therapy for NHL including chemotherapy or immunotherapy e.g., monoclonal antibody-based therapy. Patients may have received involved field radiation therapy. see Section 4.2.1)
Description

PriorSystemicTherapyAdministeredInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Any corticosteroid use within two weeks prior to study entry (except for maintenance therapy of non-malignant disease No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease. see Section 4.2.2)
Description

SteroidTherapyAdministeredInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Metathesaurus ObjectClass
C0149783
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Number of nodal sites (Mark one with an X. Low or intermediate-risk disease by the follicular lymphoma international prognostic index FLIPI score see Section 4.3)
Description

PositiveLymphNodeInvolvementType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
Hemoglobin (g/dl)
Description

LaboratoryProcedureHemoglobinResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Lactate Dehydrogenase (LDH U/l)
Description

LaboratoryProcedureLactateDehydrogenaseResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25184
UMLS 2011AA Property
C0022917
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Lactate Dehydrogenase ULN (LDH U/l)
Description

LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue

Data type

double

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25184
UMLS 2011AA Property
C0022917
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C38024
UMLS 2011AA ValueDomain
C0205369
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
U/L
FLIPI score (Mark one with an X)
Description

PersonFollicularLymphomaStagingOutcomeType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C3209
UMLS 2011AA Property
C0024301
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C15608
UMLS 2011AA Property
C0332305
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Performance Status (ECOG) (Mark one with an X ECOG performance status <= 2 see Section 4.4)
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Any known CNS involvement (No known CNS involvement by lymphoma see Section 4.6)
Description

CentralNervousSystemProgressionInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C12438
UMLS 2011AA ObjectClass
C0927232
Age (Age >= 18 years of age see Section 4.7)
Description

PersonReportedAgeValue

Data type

double

Measurement units
  • year
Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
year
Does the patient have HIV infection (HIV+ patients are eligible, provided they meet the parameters in Section 4.8)
Description

HumanImmunodeficiencyVirusDiagnosisInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C14219
UMLS 2011AA ObjectClass
C0019682
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
CD4+ Count (If yes /mm^3)
Description

LaboratoryProcedureCD4-PositiveT-LymphocyteHelper-InducerT-LymphocyteOutcomeCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12537
UMLS 2011AA Property
C0039215
NCI Thesaurus Property
C12538
UMLS 2011AA Property
C0018894
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Evidence of coinfection with hepatitis B or C or evidence of a resistant strain of HIV
Description

HumanImmunodeficiencyVirusConcurrentHepatitisAHepatitisBDiagnosisInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C14219
UMLS 2011AA ObjectClass
C0019682
NCI Thesaurus Property
C14215
UMLS 2011AA Property
C0019169
NCI Thesaurus Property
C14325
UMLS 2011AA Property
C0206437
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property
C25456
UMLS 2011AA Property
C0205420
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient on anti-HIV therapy
Description

HighlyActiveAntiretroviralTherapyAdministeredIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16165
UMLS 2011AA ObjectClass
C0887947
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
HIV viral load (If no copies HIV RNA/mL)
Description

HumanImmunodeficiencyVirusViralLoadAssayPerformedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C14219
UMLS 2011AA ObjectClass
C0019682
NCI Thesaurus ObjectClass
C51952
UMLS 2011AA ObjectClass
C0376705
NCI Thesaurus ObjectClass
C16341
UMLS 2011AA ObjectClass
C0005507
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
HIV viral load (If no copies HIV RNA/mL)
Description

HumanImmunodeficiencyVirusViralLoadAssayPerformedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C14219
UMLS 2011AA ObjectClass
C0019682
NCI Thesaurus ObjectClass
C51952
UMLS 2011AA ObjectClass
C0376705
NCI Thesaurus ObjectClass
C16341
UMLS 2011AA ObjectClass
C0005507
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Is the patient HBV seropositive (HBsAg + HBV seropositive patients HBsAg + are eligible, provided they meet the parameters in Section 4.9)
Description

SerologicalHematologyHepatitisBVirusSurfaceAntibodyTestInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus ObjectClass
C41264
UMLS 2011AA ObjectClass
C0205473
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C62796
UMLS 2011AA Property
C0369334
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
If HBsAg+, was HBV DNA testing performed
Description

SerologicalHematologyHepatitisBSurfaceAntigenTestInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus ObjectClass
C41264
UMLS 2011AA ObjectClass
C0205473
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C62786
UMLS 2011AA Property
C0019168
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Was evidence of active HBV infection detected
Description

HepaticInfectionPersonalMedicalHistoryInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Metathesaurus ObjectClass
C0021311
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Serum or urine Beta-HCG (Non-pregnant and non-nursing see Section 4.10)
Description

LaboratoryProcedureBetaHumanChorionicGonadotropinOutcomeStatus

Data type

text

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C17479
UMLS 2011AA Property
C0106132
ANC (u/l Granulocytes >= 1,000/ul see Section 4.11)
Description

LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Platelets (u/L Platelets >= 75,000/ul see Section 4.11)
Description

LaboratoryProcedurePlateletResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
1000/uL
Serum Creatinine (mL/min Creatinine clearance >= 30 mL/min see Section 4.11)
Description

LaboratoryProcedureCreatinineResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Bilirubin (Bilirubin <= 2x ULN* see Section 4.11 * Unless secondary to Gilbert's or hepatic involvement of NHL)
Description

LaboratoryProcedureTotalBilirubinResultValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Bilirubin ULN
Description

LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
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1 forms
  1. StudyEvent: CALGB 50901 Eligibility Checklist Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Eligibility Checklist
Item
Hematopoietic Diagnosis (Mark one with an X. see Section 4.1.1 Histologically confirmed follicular lymphoma, WHO classification grade 1, 2, or 3a without histologic transformation that is stage III, IV or bulky stage II i.e., single mass >= 7 cm in any uni-dimensional measurement)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C13324 (NCI Thesaurus ValueDomain)
C0229601 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.1
Code List
Hematopoietic Diagnosis (Mark one with an X. see Section 4.1.1 Histologically confirmed follicular lymphoma, WHO classification grade 1, 2, or 3a without histologic transformation that is stage III, IV or bulky stage II i.e., single mass >= 7 cm in any uni-dimensional measurement)
CL Item
Follicular Lymphoma Grade I (Follicular lymphoma - grade I)
CL Item
Follicular Lymphoma Grade II (Follicular lymphoma - grade II)
CL Item
Follicular Lymphoma Grade IIIa (Follicular lymphoma - grade IIIa)
Item
Modified Ann Arbor Stage (Mark one with an X. see Section 4.1.1)
text
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CL.2
Code List
Modified Ann Arbor Stage (Mark one with an X. see Section 4.1.1)
CL Item
II (II)
CL Item
IIE (IIE)
CL Item
III (III)
CL Item
IIIE (IIIE)
CL Item
IIIS (IIIS)
CL Item
IIIE+S (IIIE+S)
CL Item
IV (IV)
Item
Does institutional flow cytometry or immunohistochemistry confirm CD20 antigen expression (Tumor tissue must be confirmed to express the CD20 antigen by institutional flow cytometry or immunohistochemistry. see Section 4.1.2)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12476 (NCI Thesaurus Property)
C0039194 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38896 (NCI Thesaurus Property)
C0054946 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.3
Code List
Does institutional flow cytometry or immunohistochemistry confirm CD20 antigen expression (Tumor tissue must be confirmed to express the CD20 antigen by institutional flow cytometry or immunohistochemistry. see Section 4.1.2)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
BaselineMalignantNeoplasmLongestDiameterMeasurement
Item
Baseline Longest Diameter of Lesion (cm of the largest involved node Patient must have at least one site of measurable disease that is greater than 1 cm in diameter present either on physical exam or imaging studies. see Section 4.1.3 and 4.5)
double
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property)
C1522425 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus ValueDomain)
C1301886 (UMLS 2011AA ValueDomain)
Item
Any prior systemic therapy for NHL other than involved field radiation therapy (No prior therapy for NHL including chemotherapy or immunotherapy e.g., monoclonal antibody-based therapy. Patients may have received involved field radiation therapy. see Section 4.2.1)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.4
Code List
Any prior systemic therapy for NHL other than involved field radiation therapy (No prior therapy for NHL including chemotherapy or immunotherapy e.g., monoclonal antibody-based therapy. Patients may have received involved field radiation therapy. see Section 4.2.1)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Any corticosteroid use within two weeks prior to study entry (except for maintenance therapy of non-malignant disease No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease. see Section 4.2.2)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0149783 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.5
Code List
Any corticosteroid use within two weeks prior to study entry (except for maintenance therapy of non-malignant disease No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease. see Section 4.2.2)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Number of nodal sites (Mark one with an X. Low or intermediate-risk disease by the follicular lymphoma international prognostic index FLIPI score see Section 4.3)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
CL.6
Code List
Number of nodal sites (Mark one with an X. Low or intermediate-risk disease by the follicular lymphoma international prognostic index FLIPI score see Section 4.3)
CL Item
<= 4 Sites (<= 4 sites)
CL Item
> 4 Sites (> 4 sites)
LaboratoryProcedureHemoglobinResultUnspecifiedValue
Item
Hemoglobin (g/dl)
double
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLactateDehydrogenaseResultUnspecifiedValue
Item
Lactate Dehydrogenase (LDH U/l)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue
Item
Lactate Dehydrogenase ULN (LDH U/l)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Item
FLIPI score (Mark one with an X)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C3209 (NCI Thesaurus Property)
C0024301 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C15608 (NCI Thesaurus Property)
C0332305 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.7
Code List
FLIPI score (Mark one with an X)
CL Item
0-1 (0-1)
CL Item
2 (2)
CL Item
>=3 (>=3)
Item
Performance Status (ECOG) (Mark one with an X ECOG performance status <= 2 see Section 4.4)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.8
Code List
Performance Status (ECOG) (Mark one with an X ECOG performance status <= 2 see Section 4.4)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
Item
Any known CNS involvement (No known CNS involvement by lymphoma see Section 4.6)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)
CL.9
Code List
Any known CNS involvement (No known CNS involvement by lymphoma see Section 4.6)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PersonReportedAgeValue
Item
Age (Age >= 18 years of age see Section 4.7)
double
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Does the patient have HIV infection (HIV+ patients are eligible, provided they meet the parameters in Section 4.8)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.10
Code List
Does the patient have HIV infection (HIV+ patients are eligible, provided they meet the parameters in Section 4.8)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureCD4-PositiveT-LymphocyteHelper-InducerT-LymphocyteOutcomeCount
Item
CD4+ Count (If yes /mm^3)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12537 (NCI Thesaurus Property)
C0039215 (UMLS 2011AA Property)
C12538 (NCI Thesaurus Property)
C0018894 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
Evidence of coinfection with hepatitis B or C or evidence of a resistant strain of HIV
text
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C14215 (NCI Thesaurus Property)
C0019169 (UMLS 2011AA Property)
C14325 (NCI Thesaurus Property)
C0206437 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.11
Code List
Evidence of coinfection with hepatitis B or C or evidence of a resistant strain of HIV
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Patient on anti-HIV therapy
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16165 (NCI Thesaurus ObjectClass)
C0887947 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.12
Code List
Patient on anti-HIV therapy
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
HumanImmunodeficiencyVirusViralLoadAssayPerformedValue
Item
HIV viral load (If no copies HIV RNA/mL)
double
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C51952 (NCI Thesaurus ObjectClass)
C0376705 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus ObjectClass)
C0005507 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HumanImmunodeficiencyVirusViralLoadAssayPerformedValue
Item
HIV viral load (If no copies HIV RNA/mL)
double
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C51952 (NCI Thesaurus ObjectClass)
C0376705 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus ObjectClass)
C0005507 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Is the patient HBV seropositive (HBsAg + HBV seropositive patients HBsAg + are eligible, provided they meet the parameters in Section 4.9)
text
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C41264 (NCI Thesaurus ObjectClass)
C0205473 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C62796 (NCI Thesaurus Property)
C0369334 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.13
Code List
Is the patient HBV seropositive (HBsAg + HBV seropositive patients HBsAg + are eligible, provided they meet the parameters in Section 4.9)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If HBsAg+, was HBV DNA testing performed
text
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C41264 (NCI Thesaurus ObjectClass)
C0205473 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C62786 (NCI Thesaurus Property)
C0019168 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.14
Code List
If HBsAg+, was HBV DNA testing performed
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was evidence of active HBV infection detected
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C0021311 (NCI Metathesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.15
Code List
Was evidence of active HBV infection detected
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Serum or urine Beta-HCG (Non-pregnant and non-nursing see Section 4.10)
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C17479 (NCI Thesaurus Property)
C0106132 (UMLS 2011AA Property)
CL.16
Code List
Serum or urine Beta-HCG (Non-pregnant and non-nursing see Section 4.10)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Not Applicable (Not applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue
Item
ANC (u/l Granulocytes >= 1,000/ul see Section 4.11)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePlateletResultSpecifiedValue
Item
Platelets (u/L Platelets >= 75,000/ul see Section 4.11)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUnspecifiedValue
Item
Serum Creatinine (mL/min Creatinine clearance >= 30 mL/min see Section 4.11)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin (Bilirubin <= 2x ULN* see Section 4.11 * Unless secondary to Gilbert's or hepatic involvement of NHL)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue
Item
Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
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