CALGBFormIdentifierNumber
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)
ProtocolCALGBIdentifierNumber
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
PatientCALGBIdentifierNumber
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
TreatmentFirstDoseBeginDate
Item
Date of First dose for this reporting period
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentCourseEndDate
Item
Cycle end date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
Item
Are data amended
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Code List
Are data amended
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientInitialsName
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientMedicalRecordNumber
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
ParticipatingGroupName
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient 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)
TherapyCourseNumber
Item
Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
PersonBodySurfaceAreaValue
Item
BSA (m^2)
double
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
DoxorubicinAgentCourseTotalDose
Item
Total doxorubicin dose received this cycle (mg)
double
C456 (NCI Thesaurus ObjectClass)
C0013089 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
Item
Method of administration
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL111054 (NCI Metathesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
Code List
Method of administration
CL Item
Bolus Injection (Bolus injection)
CL Item
Infusion (Infusion)
C15388 (NCI Thesaurus)
C0574032 (UMLS 2011AA)
Item
Was the doxorubicin dose reduced this cycle
text
C456 (NCI Thesaurus ObjectClass)
C0013089 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25640 (NCI Thesaurus Property)
C0392756 (UMLS 2011AA Property)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
Code List
Was the doxorubicin dose reduced this cycle
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned Per Protocol (Yes, planned per protocol)
CL Item
Yes, Unplanned Per Protocol (Yes, unplanned per protocol)
SorafenibAgentCourseTotalDose
Item
Total sorafenib dose received this cycle
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C61948 (NCI Thesaurus ObjectClass)
C1174389 (UMLS 2011AA ObjectClass)
Item
Dose level received on reporting period start date
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
Code List
Dose level received on reporting period start date
CL Item
400 Mg Every 12 Hrs (400 mg every 12 hrs)
CL Item
400 Mg Every Day (400 mg every day)
CL Item
400 Mg Every Other Day (400 mg every other day)
CL Item
Not Received (Not received)
Item
Dose level received on reporting period start date
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
Code List
Dose level received on reporting period start date
CL Item
400 Mg Every 12 Hrs (400 mg every 12 hrs)
CL Item
400 Mg Every Day (400 mg every day)
CL Item
400 Mg Every Other Day (400 mg every other day)
CL Item
Not Received (Not received)
Item
Was the sorafenib dose reduced during this cycle
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C61948 (NCI Thesaurus ObjectClass)
C1174389 (UMLS 2011AA ObjectClass)
C25640 (NCI Thesaurus Property)
C0392756 (UMLS 2011AA Property)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
Code List
Was the sorafenib dose reduced during this cycle
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned Per Protocol (Yes, planned per protocol)
CL Item
Yes, Unplanned Per Protocol (Yes, unplanned per protocol)
Item
Were any doses of sorfenib missed this cycle
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C61948 (NCI Thesaurus ObjectClass)
C1174389 (UMLS 2011AA ObjectClass)
C54031 (NCI Thesaurus Property)
C1705492 (UMLS 2011AA Property)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
Code List
Were any doses of sorfenib missed this cycle
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned Per Protocol (Yes, planned per protocol)
CL Item
Yes, Unplanned Per Protocol (Yes, unplanned per protocol)
SorafenibAgentNotAdministeredTotalDoseCount
Item
Number of missed sorafenib doses
double
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C61948 (NCI Thesaurus ObjectClass)
C1174389 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
Did patient receive G-CSF or GM-CSF per protocol
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20586 (NCI Thesaurus ObjectClass)
C0009392 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Code List
Did patient receive G-CSF or GM-CSF per protocol
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ColonyStimulatingFactorUseDoseStartDate
Item
Date of first dose of G-CSF/GM-CSF during this reporting period
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20586 (NCI Thesaurus ObjectClass)
C0009392 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
ProtocolDeviationDescriptionText
Item
Specify deviation (If no,)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Did the patient receive any additional supportive care during this reporting period
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
Code List
Did the patient receive any additional supportive care during this reporting period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Non-ProtocolSupportTherapyText
Item
Yes specify
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
Item
Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AlternativeTherapyAdministeredSpecify
Item
Alternative therapy, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25415 (NCI Thesaurus ObjectClass)
C1523987 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Off-treatmentReasonSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
ResponsiblePersonName
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormOriginalCompleteDate
Item
Date Form Originally Completed
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)