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  1. StudyEvent: CALGB 50901 Eligibility Checklist Form
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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-2)
C0229601 (UMLS 2011AA ValueDomain-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
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)
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)
LaboratoryProcedureT-LymphocyteCD20AntigenOutcomeInd-3
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)
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12476 (NCI Thesaurus Property)
C0039194 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C38896 (NCI Thesaurus Property-3)
C0054946 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
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)
float
C25213 (NCI Thesaurus ObjectClass)
C1442488 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus ValueDomain-2)
C1301886 (UMLS 2011AA ValueDomain-2)
Prior systemic therapy
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)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1515119 (UMLS CUI-1)
C15698 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
SteroidTherapyAdministeredInd-2
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)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C0149783 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
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)
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)
Hemoglobin
Item
Hemoglobin (g/dl)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureLactateDehydrogenaseResultUnspecifiedValue
Item
Lactate Dehydrogenase (LDH U/l)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property-2)
C0022917 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LDH ULN
Item
Lactate Dehydrogenase ULN (LDH U/l)
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)
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-2)
C1274040 (UMLS 2011AA Property-2)
C15608 (NCI Thesaurus Property-3)
C0332305 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
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)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
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)
CentralNervousSystemProgressionInd-3
Item
Any known CNS involvement (No known CNS involvement by lymphoma see Section 4.6)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12438 (NCI Thesaurus ObjectClass)
C3714787 (UMLS 2011AA ObjectClass)
PersonReportedAgeValue
Item
Age (Age >= 18 years of age see Section 4.7)
float
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25150 (NCI Thesaurus Property-2)
C0001779 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HumanImmunodeficiencyVirusDiagnosisInd-3
Item
Does the patient have HIV infection (HIV+ patients are eligible, provided they meet the parameters in Section 4.8)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
LaboratoryProcedureCD4-PositiveT-LymphocyteHelper-InducerT-LymphocyteOutcomeCount
Item
CD4+ Count (If yes /mm^3)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12537 (NCI Thesaurus Property-2)
C0039215 (UMLS 2011AA Property-2)
C12538 (NCI Thesaurus Property-3)
C0018894 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
HumanImmunodeficiencyVirusConcurrentHepatitisAHepatitisBDiagnosisInd-3
Item
Evidence of coinfection with hepatitis B or C or evidence of a resistant strain of HIV
boolean
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C14215 (NCI Thesaurus Property)
C0019169 (UMLS 2011AA Property)
C14325 (NCI Thesaurus Property-2)
C0206437 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25456 (NCI Thesaurus Property-4)
C0205420 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
HighlyActiveAntiretroviralTherapyAdministeredIndicator
Item
Patient on anti-HIV therapy
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16165 (NCI Thesaurus ObjectClass)
C0887947 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
HumanImmunodeficiencyVirusViralLoadAssayPerformedValue
Item
HIV viral load (If no copies HIV RNA/mL)
float
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C51952 (NCI Thesaurus ObjectClass-2)
C0376705 (UMLS 2011AA ObjectClass-2)
C16341 (NCI Thesaurus ObjectClass-3)
C0005507 (UMLS 2011AA ObjectClass-3)
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)
float
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C51952 (NCI Thesaurus ObjectClass-2)
C0376705 (UMLS 2011AA ObjectClass-2)
C16341 (NCI Thesaurus ObjectClass-3)
C0005507 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
SerologicalHematologyHepatitisBVirusSurfaceAntibodyTestInd-3
Item
Is the patient HBV seropositive (HBsAg + HBV seropositive patients HBsAg + are eligible, provided they meet the parameters in Section 4.9)
boolean
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C41264 (NCI Thesaurus ObjectClass-2)
C0205473 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C62796 (NCI Thesaurus Property-2)
C0369334 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
SerologicalHematologyHepatitisBSurfaceAntigenTestInd-3
Item
If HBsAg+, was HBV DNA testing performed
boolean
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C41264 (NCI Thesaurus ObjectClass-2)
C0205473 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C62786 (NCI Thesaurus Property-2)
C0019168 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
HepaticInfectionPersonalMedicalHistoryInd-3
Item
Was evidence of active HBV infection detected
boolean
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)
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-2)
C0106132 (UMLS 2011AA Property-2)
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)
ANC
Item
ANC (u/l Granulocytes >= 1,000/ul see Section 4.11)
float
C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Platelets
Item
Platelets (u/L Platelets >= 75,000/ul see Section 4.11)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine, Serum
Item
Serum Creatinine (mL/min Creatinine clearance >= 30 mL/min see Section 4.11)
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin (Bilirubin <= 2x ULN* see Section 4.11 * Unless secondary to Gilbert's or hepatic involvement of NHL)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Bilirubin, Total ULN
Item
Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

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