ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended? (If yes, please circle amended items in red)
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item
Patient?s Vital Status
text
Code List
Patient?s Vital Status
DeathDate/LastContactDate
Item
Date of Last Contact or Death (M D Y)
date
Item
Cause of Death (if applicable)
text
Code List
Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Describe cause of death
text
CycleNumber
Item
Cycle Number
text
AgentTotalDose
Item
Oxaliplatin Dose (mg)
float
AgentBeginDate
Item
Oxaliplatin begin date (M D Y)
date
Item
If yes, choose one:
text
Code List
If yes, choose one:
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Planned (i.e., the treatment was changed according to protocol guidelines))
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Unplanned (i.e., the treatment change was not part of protocol guidelines))
CL Item
Both planned and unplanned, specify unplanned changes above (Both planned and unplanned, specify unplanned changes above)
TherapyModificationName
Item
Name of therapy
text
TherapyModificationText
Item
Type of therapy modification
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
DoseModificationReason
Item
Reason for therapy modification
text
Non-ProtocolTherapyInd,DuringProtocol
Item
Was any non-protocol therapy given during protocol treatment (not previously reported)?
boolean
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