RegistrationStep
Item
Registration Step
text
CycleNumber
Item
Cycle Number
text
Patient'sName
Item
Patient?s Name
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
ECOGPatientID
Item
ECOG Patient ID
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
Item
Are data amended? (If yes, please circle amended items in red)
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Code List
Are data amended? (If yes, please circle amended items in red)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
SpecimenLabIdentifierName
Item
Laboratory Name:
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
Lab,Hematology,SampleCollectionDate
Item
Date obtained (M D Y)
date
WBCcount(x1000),LLN
Item
WBC count (x1000), LLN
text
Lab,Hematology,WBC
Item
WBC count (x1000), Value
double
Lab,Hematology,GranulocyteCount
Item
Granulocyte count (AGC/ANC), Value (Do not report % granulocytes/neutrophils; report absolute count without decimal.)
double
Plateletscount(x1000),LLN
Item
Platelet count (x1000), LLN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
Lab,Hematology,Platelets
Item
Platelet count (x1000), Value
double
Hemoglobin(g/dl),LLN
Item
Hemoglobin (g/dl), LLN
text
Lab,Hematology,Hemoglobin
Item
Hemoglobin (g/dl), Value
double
Totalbilirubin(mg/dl),ULN
Item
Total bilirubin (mg/dl), ULN
text
Lab,Hepatic,Bilirubin
Item
Total bilirubin (mg/dl), Value
double
SGOT(AST)ULN
Item
SGOT (AST) (U/L), ULN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,SGOT
Item
SGOT (AST) (U/L), Value
double
Creatinine(mg/dl),ULN
Item
Creatinine (mg/dl), ULN
text
Lab,Renal,Creatinine
Item
Creatinine (mg/dl), Value
double
Albumin(g/dl),LLN
Item
Albumin (g/dl), LLN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
Lab,Chemistry,Albumin
Item
Albumin (g/dl)
double
Item
CTC Adverse Event Attribution Code
text
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possibly (possible)
CL Item
Probably (probable)
CL Item
Definitely (definite)
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)