FormCompletionDate,Original
Item
Date form originally completed (m d y)
date
FormCompletionDate,Amended
Item
Date form amended (m d y)
date
ResponsiblePersonReportingChangeLastName
Item
Person amending form, last name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientName,Last
Item
Patient Name, Last
text
PatientName,First
Item
Patient Name, First
text
PatientStudyID
Item
Patient Study ID
text
PersonCompletingForm,LastName
Item
Person Completing Form, Last Name
text
Item
Patient's vital status
text
Code List
Patient's vital status
Item
Primary cause of death
text
Code List
Primary cause of death
CL Item
Due To This Disease (Due to this disease)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To Other Cause (Due to other cause)
DeathReason,Specify
Item
Death due to other cause (specify)
text
DeathReason,Specify
Item
Death due to other cause (specify)
text
DeathDate/LastContactDate
Item
Death date / last contact date (m d y)
date
Item
Was patient unable to be contacted for current scheduled follow-up?
text
Code List
Was patient unable to be contacted for current scheduled follow-up?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Has the patient been diagnosed with a new progression?
text
Code List
Has the patient been diagnosed with a new progression?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ProgressionDate
Item
Date of progression (recurrence m d y)
date
ProgressionSite
Item
Site(s) of progression
text
Item
What was the method used to determine progression?
text
Code List
What was the method used to determine progression?
CL Item
Histology (Histologic)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
CL Item
Radiographic (Radiologic)
CL Item
Physical Exam (Physical exam)
CL Item
Tumor Markers (Tumor marker)
MarkerName
Item
Marker 2 (Marker names & values)
text
MarkerName
Item
Marker 2 (Marker names & values)
text
TumorMarkerAssessmentValue
Item
Marker 2 Value
double
C25367 (NCI Thesaurus Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
TumorMarkerAssessmentValue
Item
Marker 2 Value
double
C25367 (NCI Thesaurus Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
TumorMarker,CA125Date
Item
Date of CA125 (s or other biomarkers Please provide dates of the measurements corresponding to the values given. m d y)
date
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported? (myelodysplastic syndrome)
text
Code List
Has a new primary cancer or MDS been diagnosed that has not been previously reported? (myelodysplastic syndrome)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
NewPrimaryCancerDate
Item
Date of diagnosis (m d y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
NewPrimarySite
Item
Site(s) of new primary
text
Item
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >/= 3), long term toxicity that has not been previously reported?
text
Code List
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >/= 3), long term toxicity that has not been previously reported?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LateAdverseEventTerm
Item
Adverse event term
text
LateAdverseEventGrade
Item
Late adverse event grade
text
LateAdverseEventOnsetDate
Item
Late Adverse Event Onset Date (m d y)
date
Item
CTC adverse event attribution (*Adverse Event Attribution Codes 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
text
Code List
CTC adverse event attribution (*Adverse Event Attribution Codes 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possibly (Possibly)
CL Item
Probably (Probably)
CL Item
Definitely (Definitely)
Item
Is the patient receiving any non-protocol cancer therapy not previously reported?
text
Code List
Is the patient receiving any non-protocol cancer therapy not previously reported?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
OtherNon-ProtocolTherapyName
Item
Name of other non-protocol therapy
text
Non-ProtocolTherapyDate,First
Item
Date of first non-protocol therapy (m d y)
date
AdditionalTherapyReason
Item
Additional therapy reason
text
ParticipatingGroupCode
Item
Participating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
ParticipatingGroupProtocolNumber
Item
Participating Group Protocol Number
double
PatientParticipatingIdentifierNumber
Item
Participating Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)