Breast Cancer NCT00066703 Treatment - Chemotherapy Form (Form 25/26-CT) - 2167893v3.0

Chemotherapy Form (Form 25/26-CT) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD161F67-0591-4F92-E034-0003BA12F5E7

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  1. StudyEvent: Chemotherapy Form (Form 25/26-CT)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Ccrr Module For Chemotherapy Form (form 25/26-ct)
PatientInternationalBreastCancerStudyGroupIdentifierNumber
Item
IBCSG 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)
C25530 (NCI Thesaurus Property-2)
C1512890 (UMLS 2011AA Property-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Birth Date
Item
Patient's Date of Birth
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
ParticipatingCenter/Affiliate
Item
Participating Center/Affiliate
text
CenterCode
Item
Center Code
text
Item
Did the patient complete chemotherapy?
text
Code List
Did the patient complete chemotherapy?
CL Item
No, Will Never Start (no, will never start)
CL Item
No, Started But Stopped Early (no, started but stopped early)
CL Item
Yes, Completed With Modifications Or Delays Of One Week Or More (yes, completed with modifications or delays of one week or more)
CL Item
Yes, Completed As Planned (yes, completed as planned)
Item
Reason code, specify (reason treatment ended)
text
Code List
Reason code, specify (reason treatment ended)
CL Item
Patient Refused (patient refused)
CL Item
Adverse Event (adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Medical Decision (medical decision)
CL Item
Recurrence (recurrence)
C3352 (NCI Thesaurus)
C0034897 (UMLS 2011AA)
CL Item
Death On Study (death on study)
CL Item
Error (error)
C0743559 (NCI Metathesaurus)
CL Item
Other, Specify (other, specify)
Adverseevent,specify
Item
adverse event, specify
text
Medicaldecision,specify
Item
medical decision, specify
text
OffTreatmentReason,Other
Item
other, specify
text
Item
Reasons chemotherapy was delayed or modified
text
Code List
Reasons chemotherapy was delayed or modified
CL Item
Hematologic Toxicity (hematologic toxicity)
CL Item
Other Toxicity, Specify (other toxicity, specify)
CL Item
Reason Other Than Toxicity, Specify (reason other than toxicity, specify)
othertoxicity,specify
Item
other toxicity, specify
text
reasonotherthantoxicity,specify
Item
reason other than toxicity, specify
text
PriorChemotherapyBeginDate
Item
Date of first dose of chemotherapy
date
Dateoflastdoseofchemotherapy
Item
Date of last dose of chemotherapy
text
TotalCourseNumber
Item
Total number of cycles of the regimen of chemotherapy given
float
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
Date
Item
Date
text
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
AgentDoseLevelValue
Item
Agent Dose
text
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25554 (NCI Thesaurus Property-2)
C0441889 (UMLS 2011AA Property-2)
AgentAdminRoute
Item
Route of Administration
text
Schedule&Frequency
Item
Schedule & Frequency
text
CTCAdverseEventWBCGrade
Item
Leukocytes CTCAE Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventPlateletGrade
Item
Platelets CTCAE Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventHemoglobinGrade
Item
Hemoglobin CTCAE Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventStomatitisGrade
Item
Mucositis/Stomatis CTCAE Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventFatigueGrade
Item
Fatigue CTCAE Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventDizzinessGrade
Item
Dizziness/lightheadedness CTCAE Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventConsciousnessGrade
Item
Somnolence/Depressed level of consciousness CTCAE Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventMemoryGrade
Item
Memory impairment CTCAE Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CTCAdverseEventDepressionGrade
Item
Mood alternation-depression CTCAE Grade
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventPeripheralSensoryNeuropathyGrade
Item
Neuropathy-sensory CTCAE Grade
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C0151313 (NCI Metathesaurus Property)
DidthepatienthaveotherGrade3orhigheradverseevent(s)?
Item
Did the patient have other Grade 3 or higher adverse event(s)?
boolean
CTCAdverseEventTermSpecify
Item
If yes, specify other CTCAE terms not listed
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25703 (NCI Thesaurus Property)
C1515273 (UMLS 2011AA Property)
CTC Adverse Event Grade
Item
CTCAE Grade
float
C41331 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)

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