PatientNationalCancerInstituteofCanadaIdentifierNumber
Item
NCIC Patient ID (NCIC CTG Patient Serial Number issued at the time of randomization)
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)
C25582 (NCI Thesaurus Property-2)
C1513884 (UMLS 2011AA Property-2)
Patient Initials
Item
Patient Initials (first-middle-last)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No. (if permitted by REB)
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
PhysicianInvestigatorIdentifierNumber
Item
Investigator No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
InvestigatorFirstName
Item
Investigator First Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
TreatingPhysicianMiddleName
Item
Investigator Middle Name
text
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
InvestigatorLastName
Item
Investigator Last Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property-2)
C1517741 (UMLS 2011AA Property-2)
Item
Cycle Number
text
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Chemotherapy cycle
Item
Other, specify
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C1302181 (UMLS CUI-1)
C25616 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C25472 (NCI Thesaurus ValueDomain-2)
C25275 (NCI Thesaurus ValueDomain-3)
AssessmentFirstDayDate
Item
Day 1 of this cycle (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
PatientPhysicalExaminationDate
Item
Date of Physical Exam (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
Code List
ECOG Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
PaclitaxelAgentDuringReportingPeriodAdministeredInd-2
Item
Was the agent Paclitaxel administered during this reporting period
boolean
C1411 (NCI Thesaurus ObjectClass)
C0144576 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25490 (NCI Thesaurus Property-4)
C0347984 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CarboplatinAgentDuringReportingPeriodAdministeredInd-2
Item
Was the agent Carboplatin administered during this reporting period
boolean
C1282 (NCI Thesaurus ObjectClass)
C0079083 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25490 (NCI Thesaurus Property-4)
C0347984 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CisplatinAgentDuringReportingPeriodAdministeredInd-2
Item
Was the agent Cisplatin administered during this reporting period
boolean
C376 (NCI Thesaurus ObjectClass)
C0008838 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25490 (NCI Thesaurus Property-4)
C0347984 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Day of cycle
text
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus ObjectClass-2)
C1521801 (UMLS 2011AA ObjectClass-2)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property-2)
C0750729 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Chemotherapy cycle
Item
Other, specify
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C1302181 (UMLS CUI-1)
C25616 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C25472 (NCI Thesaurus ValueDomain-2)
C25275 (NCI Thesaurus ValueDomain-3)
Agent Administered Date
Item
Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
Item
Route
text
C25284 (NCI Thesaurus ValueDomain)
C0013153 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus ObjectClass-2)
C25169 (NCI Thesaurus Property)
CL Item
Intravenous (IV)
X-MO-6794 (MGED)
X-MO-6794 (MGED-2)
CL Item
Intraperitoneal Route Of Administration (IP)
C38258 (NCI Thesaurus)
C1522583 (UMLS 2011AA)
TotalAgentActualCourseDose
Item
Total Actual Dose of Agents/Drugs for this cycle (mg)
float
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25274 (NCI Thesaurus Property-2)
C0237400 (UMLS 2011AA Property-2)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25274 (NCI Thesaurus ValueDomain-2)
C0237400 (UMLS 2011AA ValueDomain-2)
AgentWeightLossDoseModificationInd-2
Item
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C25488 (NCI Thesaurus Property-2)
C0178602 (UMLS 2011AA Property-2)
C25572 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DoseModificationDate
Item
Date of dose modifications (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Dose modification (Type of)
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Code List
Dose modification (Type of)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Dose Omitted (Dose omitted)
CL Item
Dose Delayed (Dose delayed)
CL Item
Change Of Route (Change of route)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Adverse Event causing Dose Modification, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C41331 (NCI Thesaurus Property)
C1707811 (UMLS CUI-2)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-3)
C25572 (NCI Thesaurus Property-2)
ProtocolAgentNotCompleteAdministrationAdverseEventInd-2
Item
Protocol mandated
boolean
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain-2)
C0877248 (UMLS 2011AA ValueDomain-2)
Assessment Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
CL Item
Milliliters Per Minute (ml/min)
CL Item
Milliliters Per Second (ml/sec)
Item
Day of cycle
text
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus ObjectClass-2)
C1521801 (UMLS 2011AA ObjectClass-2)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property-2)
C0750729 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Chemotherapy cycle
Item
Other, specify
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C1302181 (UMLS CUI-1)
C25616 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C25472 (NCI Thesaurus ValueDomain-2)
C25275 (NCI Thesaurus ValueDomain-3)
Agent Administered Date
Item
Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
Item
Route
text
C25284 (NCI Thesaurus ValueDomain)
C0013153 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus ObjectClass-2)
C25169 (NCI Thesaurus Property)
CL Item
Intravenous (IV)
X-MO-6794 (MGED)
X-MO-6794 (MGED-2)
CL Item
Intraperitoneal Route Of Administration (IP)
C38258 (NCI Thesaurus)
C1522583 (UMLS 2011AA)
TotalAgentActualCourseDose
Item
Total Actual Dose of Agents/Drugs for this cycle (mg)
float
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25274 (NCI Thesaurus Property-2)
C0237400 (UMLS 2011AA Property-2)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25274 (NCI Thesaurus ValueDomain-2)
C0237400 (UMLS 2011AA ValueDomain-2)
AgentWeightLossDoseModificationInd-2
Item
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C25488 (NCI Thesaurus Property-2)
C0178602 (UMLS 2011AA Property-2)
C25572 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DoseModificationDate
Item
Date of dose modifications (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Dose modification (Type of)
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Code List
Dose modification (Type of)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Dose Omitted (Dose omitted)
CL Item
Dose Delayed (Dose delayed)
CL Item
Change Of Route (Change of route)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Adverse Event causing Dose Modification, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C41331 (NCI Thesaurus Property)
C1707811 (UMLS CUI-2)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-3)
C25572 (NCI Thesaurus Property-2)
ProtocolAgentNotCompleteAdministrationAdverseEventInd-2
Item
Protocol mandated
boolean
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain-2)
C0877248 (UMLS 2011AA ValueDomain-2)
Item
Day of cycle
text
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus ObjectClass-2)
C1521801 (UMLS 2011AA ObjectClass-2)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property-2)
C0750729 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Chemotherapy cycle
Item
Other, specify
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C1302181 (UMLS CUI-1)
C25616 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C25472 (NCI Thesaurus ValueDomain-2)
C25275 (NCI Thesaurus ValueDomain-3)
Agent Administered Date
Item
Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
Item
Route
text
C25284 (NCI Thesaurus ValueDomain)
C0013153 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus ObjectClass-2)
C25169 (NCI Thesaurus Property)
CL Item
Intravenous (IV)
X-MO-6794 (MGED)
X-MO-6794 (MGED-2)
CL Item
Intraperitoneal Route Of Administration (IP)
C38258 (NCI Thesaurus)
C1522583 (UMLS 2011AA)
TotalAgentActualCourseDose
Item
Total Actual Dose of Agents/Drugs for this cycle (mg)
float
C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25274 (NCI Thesaurus Property-2)
C0237400 (UMLS 2011AA Property-2)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25274 (NCI Thesaurus ValueDomain-2)
C0237400 (UMLS 2011AA ValueDomain-2)
AgentWeightLossDoseModificationInd-2
Item
Was dose modified due to weight loss (from the previous cycle due to a change in weight BSA during this reporting period)
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C25488 (NCI Thesaurus Property-2)
C0178602 (UMLS 2011AA Property-2)
C25572 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DoseModificationDate
Item
Date of dose modifications (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Dose modification (Type of)
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Code List
Dose modification (Type of)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Dose Omitted (Dose omitted)
CL Item
Dose Delayed (Dose delayed)
CL Item
Change Of Route (Change of route)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Adverse Event causing Dose Modification, other
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C41331 (NCI Thesaurus Property)
C1707811 (UMLS CUI-2)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-3)
C25572 (NCI Thesaurus Property-2)
ProtocolAgentNotCompleteAdministrationAdverseEventInd-2
Item
Protocol mandated
boolean
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain-2)
C0877248 (UMLS 2011AA ValueDomain-2)
PatientHospitalizationSpecify
Item
Reason for hospitalization
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
InpatientHospitalAdmissionDate
Item
Admission Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25182 (NCI Thesaurus ObjectClass-2)
C0021562 (UMLS 2011AA ObjectClass-2)
C25385 (NCI Thesaurus Property)
C0809949 (UMLS 2011AA Property)
InpatientHospitalDischargeDate
Item
Discharge Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25182 (NCI Thesaurus ObjectClass-2)
C0021562 (UMLS 2011AA ObjectClass-2)
C25166 (NCI Thesaurus Property)
C0030685 (UMLS 2011AA Property)
Growth factor administered
Item
Was growth factor administered? (e.g. GCSF, erythropoietin, etc. during this reporting period)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0018284 (UMLS CUI-1)
C20424 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
Item
Growth factor
text
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL Item
Epoetin Alfa (Epoetin)
C2695 (NCI Thesaurus)
C0357126 (UMLS 2011AA)
CL Item
Granulocyte-macrophage Colony-stimulating Factor (G-CSF)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
GrowthFactorAgentCurrentReportPeriodAdministeredSpecify
Item
Other, specify (If)
text
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
GrowthFactorAgentCurrentReportPeriodAdministeredBeginDate
Item
Start Date (yyyy-mmm-dd)
date
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
GrowthFactorAgentCurrentReportPeriodAdministeredEndDate
Item
Stop Date (yyyy-mmm-dd)
date
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Surgery Date
Item
Surgery Date (dd-mmm-yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C1628561 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15329 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Item
Non-Protocol Therapy Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Non-Protocol Therapy Type
CL Item
Chemotherapy (Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
CL Item
Radiation Therapy (Radiation therapy)
C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)
CL Item
Hormonal Therapy (Hormonal Therapy)
CL025695 (NCI Metathesaurus)
CL Item
Immunotherapy (Immunotherapy)
C15262 (NCI Thesaurus)
C0021083 (UMLS 2011AA)
CL Item
Other Specify (Other)
Non-ProtocolTherapyAdministeredSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Non-protocolTherapyAdministeredText
Item
Name of non-protocol cancer therapy (eg. 2nd look surgery, tamoxifen)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorAdverseEventContinuedInd-2
Item
Ongoing from previous reporting period
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C0750536 (NCI Metathesaurus Property)
Non-protocolTherapyBeginDate
Item
Treatment Start Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Medication continued
Item
Continuing at end of this reporting period
boolean
C38147 (NCI Thesaurus ValueDomain)
C0013227 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C0549178 (UMLS CUI-2)
C25409 (NCI Thesaurus Property)
C0750536 (NCI Metathesaurus Property)
Non-protocolTherapyAdministeredEndDate
Item
Treatment Stop Date (yyyy-mmm-dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
SpecimenCollectedDate
Item
Date Specimen collected (for biochemical investigations)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)
Assessment Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
PathologyCoreFacilityLaboratoryIdentifierNumber
Item
Lab ID
text
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C15896 (NCI Thesaurus ObjectClass-3)
C1511521 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Hemoglobin
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Platelets
Item
Peripheral Platelet Count
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Leukocytes (WBC)
Item
WBC
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
ANC
Item
Absolute neutrophil count
float
C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedurePerformedSpecify
Item
Other
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
SpecimenCollectedDate
Item
Date Specimen collected (for biochemical investigations)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)
Assessment Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
PathologyCoreFacilityLaboratoryIdentifierNumber
Item
Lab ID
text
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C15896 (NCI Thesaurus ObjectClass-3)
C1511521 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Creatinine, Serum
Item
Serum Creatinine
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Bilirubin, Total
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
SGOT (AST)
Item
SGOT (AST)
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)
SGPT (ALT)
Item
SGPT (ALT)
float
C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureCA-125AntigenTumorMarkerResultValue
Item
CA125
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C325 (NCI Thesaurus Property)
C0006610 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17220 (NCI Thesaurus Property-3)
C0041365 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePerformedSpecify
Item
Other
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureMagnesiumResultUnspecifiedValue
Item
Magnesium
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C29239 (NCI Thesaurus Property-2)
C0024467 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureCalciumElectrolytesOutcomeValue
Item
Calcium
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
DiseaseAssessmentResultInd-2
Item
Were disease assessment results obtained this report period?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
Item
Reason evaluation not done
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C49484 (NCI Thesaurus Property)
C1272696 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
Code List
Reason evaluation not done
CL Item
Not Required Per Protocol (Not required per protocol)
CL Item
Institution Error (Institution error)
CL Item
Patient Noncompliance (Patient noncompliance)
C0376405 (NCI Metathesaurus)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
EvaluationNotDoneReasonSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C49484 (NCI Thesaurus Property)
C1272696 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
DiseaseProgressionInd-3
Item
Was there evidence of objective disease progression at this assessment
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
DiseasePost-OperativeStatusType
Item
Did the patient have any target lesions by imaging or clinical exam on post-op baseline report
boolean
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25623 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property)
Assessment Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
LesionTargetSite
Item
Target Lesion Site (e.g. pelvis)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS 2011AA Property-2)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
Evaluation method
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
Evaluation method, specify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
TumorLargestDimensionMeasurement
Item
Dimension 1 (End of Reporting Period Measurements)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
TumorSecondDimensionMeasurement
Item
Dimension 2 (End of Reporting Period Measurements)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
LongestLesionSumDiameterMeasurement
Item
Sum of Longest Diameters of All Target Lesions
float
C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C0221198 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25697 (NCI Thesaurus Property-2)
C1515051 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
LesionNontargetBaselineLocationInd-3
Item
Were there any non-target lesions reported at baseline
boolean
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus Property)
C1518389 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C25213 (NCI Thesaurus Property-3)
C1442488 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ValueDomain-2)
C0006826 (UMLS 2011AA ValueDomain-2)
Assessment Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
LesionNontargetSite
Item
Nontarget Lesion Site (e.g. pelvis)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus Property)
C1518389 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
Evaluation method
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
Evaluation method, specify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
Item
Follow-up status of nontarget lesion (End of Reporting Period )
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Follow-up status of nontarget lesion (End of Reporting Period )
CL Item
Absent (Absent)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
CL Item
Present-no Change (Present-no change)
CL Item
Increase (Increase)
CL Item
Increased To Pd (Increased to PD)
CL Item
Unevaluable (Unevaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
NewLesionAppearanceInd-2
Item
Was the appearance of any new lesions documented (since baseline i.e. previously or current reporting periods Note: New Lesions constitute objective disease progression)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus ObjectClass-2)
C0205314 (UMLS 2011AA ObjectClass-2)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)
Assessment Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
LesionNewSite
Item
New Lesion Site (e.g. pelvis)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
Evaluation method
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
Evaluation method, specify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
Assessment Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item
Has the patient experienced any symptoms or adverse events since the last report
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property-2)
CL158136 (NCI Metathesaurus Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Has the patient experienced any symptoms or adverse events since the last report
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Not Assessed (Not assessed)
CommonToxicityCriteriaAdverseEventShortNameType
Item
CTC Adverse Event Short Name
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1806781 (UMLS 2011AA Property-2)
CTC Adverse Event Term
Item
CTC Select AE
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C38024 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
Code List
CTC AE Attribution Code
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
Seriousness Attributed to Adverse Event
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
Seriousness Attributed to Adverse Event
CL Item
Not Serious (Not serious)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Life Threatening (Life threatening)
CL Item
Hospitalized (Hospitalization, initial or prolonged)
CL Item
Disability (Disability/incapacity)
C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ConcomitantTherapeuticProcedurePerformedText
Item
Name of treatment
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
Concomitant Medication Use Indication
Item
Reason for Administration
text
C459 (NCI Thesaurus ObjectClass)
C2826696 (UMLS CUI-1)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C25638 (NCI Thesaurus ValueDomain-2)
ConcomitantMedicationAdministrationCurrentInd-3
Item
Ongoing? (from previous)
boolean
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus ValueDomain-2)
C0521116 (UMLS 2011AA ValueDomain-2)
Agent Start Date
Item
Start date
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Agent End Date
Item
Stop date
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
PatientMedicalConditionDate
Item
Date Documented (first)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property-2)
C0348080 (UMLS 2011AA Property-2)
PatientMedicalConditionText
Item
Medical condition
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property-2)
C0348080 (UMLS 2011AA Property-2)
PatientHistoryText
Item
Other Relevant Details
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
QualityofLifeCompleteAssessmentInd-2
Item
Was QoL Questionnaire completed?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
QualityofLifeCompleteAssessmentDate
Item
Date Questionnaire Completed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
Item
Specify the reason the questionnaire was not completed
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
Code List
Specify the reason the questionnaire was not completed
CL Item
Patient Kept Appointment For Examination, But Could Not Complete Questionnaire Due To Illness (Patient kept appointment for examination, but could not complete questionnaire due to illness)
CL Item
Patient Kept Appointment For Examination, But Refused To Complete Questionnaire For Reasons Other Than Illness (Patient kept appointment for examination, but refused to complete questionnaire for reasons other)
CL Item
Patient Did Not Keep Appointment (Patient did not keep appointment)
CL Item
Patient Could Not Be Contacted (Patient could not be contacted)
CL Item
Test Omitted Due To Institution/investigator Error (Questionnaire not administered due to institutional error)
CL Item
Other Reason (Other reason)
Quality-of-LifeAssessmentOtherIncompleteSpecify
Item
Specify other reason
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
CRAName
Item
CRA Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
ClinicalResearchAssociatePersonTelephoneNumber
Item
Phone number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
ClinicalResearchAssociatePersonFaxNumber
Item
Fax Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)