ProtocolCoordinatingIdentifierNumber
Item
Coordinating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CoordinatingGroupIdentifierCode
Item
Coordinating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus ObjectClass)
C0700114 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolTitleName
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C42774 (NCI Thesaurus Property)
C1705823 (UMLS 2011AA Property)
PatientCoordinatingIdentifierNumber
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientMedicalRecordNumber
Item
Patient Medical Record Number
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)
PatientInitialsName
Item
Patient Initials (L, FM)
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)
ParticipatingGroupIdentifierCode
Item
Participating Group Code (Cooperative Group where credit will be applied)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (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)
InstitutionName
Item
Institution Name (treating location/performance site)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item
Are data amended? (If data are amended, please circle in red when using paper form)
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? (If data are amended, please circle in red when using paper form)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
FirstTreatmentBeginDate
Item
First Date Protocol Therapy was Given (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentEndDate
Item
Last Date Protocol Therapy was Given (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
Item
Reason Treatment Ended (check one)
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
Reason Treatment Ended (check one)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
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
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
Disease Progression Before Active Treatment (Disease Progression before active treatment)
CL Item
Cytogenetic Resistance (Cytogenetic Resistance)
CL Item
Death On Study (Death on study)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
TreatmentTotalCourseCount
Item
Total Number of Cycles Given
double
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (decreases/increases)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (decreases/increases)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned (i.e., the treatment was changed according to protocol guidelines))
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned (i.e., the treatment change was not part of protocol guidelines))
AgentName
Item
Agent Name (Pre-filled with response: C225 [cetuximab])
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
AgentName
Item
Agent Name (Pre-filled with response: C225 [cetuximab])
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
AgentName
Item
Agent Name (Pre-filled with response: C225 [cetuximab])
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Item
Was agent modified (decreased/increased) or omitted?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Code List
Was agent modified (decreased/increased) or omitted?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was agent modified (decreased/increased) or omitted?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Code List
Was agent modified (decreased/increased) or omitted?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was agent modified (decreased/increased) or omitted?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Code List
Was agent modified (decreased/increased) or omitted?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
CL Item
Allergic Reaction (Allergic reaction)
C0085600 (NCI Metathesaurus)
CL Item
Rash/desquamation (Rash/desquamation)
CL Item
Nail Changes (Nail changes)
CL Item
Gi (specific To Patients >= 70 Years) (GI (specific to patients >= 70 years))
CL Item
Other, Non-hematologic, Specify (Other non-hematologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
CL Item
Allergic Reaction (Allergic reaction)
C0085600 (NCI Metathesaurus)
CL Item
Rash/desquamation (Rash/desquamation)
CL Item
Nail Changes (Nail changes)
CL Item
Gi (specific To Patients >= 70 Years) (GI (specific to patients >= 70 years))
CL Item
Other, Non-hematologic, Specify (Other non-hematologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
CL Item
Allergic Reaction (Allergic reaction)
C0085600 (NCI Metathesaurus)
CL Item
Rash/desquamation (Rash/desquamation)
CL Item
Nail Changes (Nail changes)
CL Item
Gi (specific To Patients >= 70 Years) (GI (specific to patients >= 70 years))
CL Item
Other, Non-hematologic, Specify (Other non-hematologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
SingleClinicalTrialProtocolAgentUnrelatedHematologicModificationText
Item
Other non-hematologic resaon agent modified ([C225] - decreased/increased/omitted)
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass)
C0205171 (UMLS 2011AA ObjectClass)
C62780 (NCI Thesaurus Property)
C0205488 (UMLS 2011AA Property)
C25328 (NCI Thesaurus Property)
C0445356 (UMLS 2011AA Property)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
SingleClinicalTrialProtocolAgentUnrelatedHematologicModificationText
Item
Other non-hematologic resaon agent modified ([C225] - decreased/increased/omitted)
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass)
C0205171 (UMLS 2011AA ObjectClass)
C62780 (NCI Thesaurus Property)
C0205488 (UMLS 2011AA Property)
C25328 (NCI Thesaurus Property)
C0445356 (UMLS 2011AA Property)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
SingleAgentProtocolTherapyModifiedSpecify
Item
Other Reason Agent Modified ([C225] decreased/increased/omitted)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
SingleAgentProtocolTherapyModifiedSpecify
Item
Other Reason Agent Modified ([C225] decreased/increased/omitted)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
SingleAgentProtocolTherapyModifiedSpecify
Item
Other Reason Agent Modified ([C225] decreased/increased/omitted)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Response Status at This Assessment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
Code List
Response Status at This Assessment
CL Item
Recurrence (Recurrence)
C3352 (NCI Thesaurus)
C0034897 (UMLS 2011AA)
CL Item
Not Evaluated (Not evaluated)
LesionAssessmentDate
Item
Assessment Date (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)