INSTRUCTIONS: Complete this form according to the on-treatment and follow up schedules. Submit original to the ECOG Coordinating Center. Keep a copy for your files. Refer to forms packet for submission schedule

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item
Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Report Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Patient Description Pre-registration Hematology/chemistry
Patient Height
Item
Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
LaboratoryProcedureLymphocyteOutcomeCount
Item
Peripheral Lymphocyte Count
float
C12535 (NCI Thesaurus Property)
C0024264 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedurePerformedLowerLimitofNormalValue
Item
LLN
float
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Granulocyte count
Item
Peripheral Granulocytes Count (AGC/ANC/mm^3)
float
C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount
Item
Peripheral Granulocytes Count LLN (AGC/ANC/mm^3)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Platelets
Item
Peripheral Platelet Count (/mm^3 x1000)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Platelets LLN
Item
Peripheral platelet count, LLN (/mm^3 x1000)
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureErythrocyteResultCount
Item
Peripheral Hematocrit Count (%)
float
C12521 (NCI Thesaurus Property)
C0014792 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureErythrocyteResultPercentageLowerLimitofNormalValue
Item
Peripheral hematocrit count LLN (%)
text
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)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
SGOT (AST)
Item
SGOT (AST) (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Laboratory Procedure Not Performed
Item
Test not done (Mark an "X" below if test not done.)
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
HematologySpecimenCollectedDate
Item
Date Hematology (Blood) Sample Obtained (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
PrimaryTumorDiagnosisDate
Item
Date of Definitive Histologic Diagnosis of Primary Tumor (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
DiseaseProgressionDate
Item
Date of Progression (tumor by serial MRI M D Y)
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)
DataUnknownText
Item
Mark an 'X' if N/A
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
Item
Histologic Type
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12439 (NCI Thesaurus ObjectClass-2)
C0006104 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
CL.2
Code List
Histologic Type
CL Item
Astrocytoma (Astrocytoma)
CL Item
9450-3 Oligodendroglioma, Nos (c71._) (Oligodendroglioma)
CL Item
Oligoastrocytoma (Oligoastrocytoma)
Item Group
Prior Brain Surgery
PriorSurgeryDate
Item
Date of prior surgery (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Extent of Resection
text
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25698 (NCI Thesaurus Property)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property)
C25332 (NCI Thesaurus Property-3)
C0439792 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Extent of Resection
CL Item
Biopsy (Biopsy)
C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)
CL Item
Bulk Removal Or 50% To 89% Removal (Bulk removal or 50% to 89% removal)
CL Item
Minimal Excision <50% Total Estimated Volume (Minimal excision <50% total estimated volume)
CL Item
Almost Total Resection >90% Removal (Almost total resection >90% removal)
Item Group
Motivation For Study Entry
Item
Medical History (Has patient been diagnosed with any of the following code response for ALL)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.4
Code List
Medical History (Has patient been diagnosed with any of the following code response for ALL)
CL Item
Headaches Associated With Mass Effect (Headaches associated with mass effect)
CL Item
Uncontrolled Seizures Despite 2 Different Antiepileptic Drug Regimens (Uncontrolled seizures despite 2 different antiepileptic drug regimens)
CL Item
Focal Neurological Symptoms (Focal neurological symptoms)
CL Item
Cognitive Symptoms Or Deficits (Cognitive symptoms or deficits)
CL Item
Tumor Progression By Serial Mris, Defined As New Enhancement (Tumor progression by serial MRIs, defined as New enhancement)
CL Item
Tumor Progression By Serial Mris, Defined As New T2 Or Flair Signal Abnormality (Tumor progression by serial MRIs, defined as New T2 or FLAIR signal abnormality)
DiagnosticImagingRadiologyDiseaseProgressionPresentInd-2
Item
Has the patient progressed radiographically (If yes answer one of the following questions)
boolean
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C17059 (NCI Thesaurus Property-2)
C0034599 (UMLS 2011AA Property-2)
CL101509 (NCI Metathesaurus Property)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PreoperativeDiagnosticImagingMaximumMalignantNeoplasmDiameterPresentMeasurement
Item
For newly diagnosed patients, or patients entering at time of progression who have had surgery for this progression, what was the pre-operative maximum tumor diameter by T2/FLAIR (cm)
float
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C54732 (NCI Thesaurus ObjectClass-2)
C0445204 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C25564 (NCI Thesaurus Property-3)
C0806909 (UMLS 2011AA Property-3)
C0332517 (NCI Metathesaurus Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
PostoperativeDiseaseProgressionDiagnosticImagingMaximumMalignantNeoplasmDiameterPresentMeasurement
Item
For patients entering with disease progression since primary surgery, and are not having new surgery for this progression, enter maximum tumor diameter at time of progression (cm)
float
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus ObjectClass-2)
C0032790 (UMLS 2011AA ObjectClass-2)
C17747 (NCI Thesaurus ObjectClass-3)
C0242656 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C25564 (NCI Thesaurus Property-3)
C0806909 (UMLS 2011AA Property-3)
C0332517 (NCI Metathesaurus Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
PatientAgeInd-2
Item
Is the patient >= 40 years old
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
AnticonvulsantMedicationAdministrationInd-3
Item
Is the person receiving anti-convulsant medication?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C264 (NCI Thesaurus ObjectClass-2)
C0003286 (UMLS 2011AA ObjectClass-2)
Item Group
Adverse Events Present At Time Of Registration (pre-treatment)
Item
CTC Adverse Event Term (include subterm if applicable Use Active Version of the NCI CTCAE v4.0)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
CL.8
Code List
CTC Adverse Event Term (include subterm if applicable Use Active Version of the NCI CTCAE v4.0)
CL Item
Seizure (Seizure)
CL Item
Thromboembolism (Thromboembolic event)
CL Item
Tinnitus (Tinnitus)
Item
CTC Adverse Event Grade (Use grade 1-4 per CTCAE)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
CL.9
Code List
CTC Adverse Event Grade (Use grade 1-4 per CTCAE)
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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