INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period Start Date
Item
Reporting Period Start Date (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Treatment Phase
Item
Treatment Phase
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C0442711 (UMLS 2011AA ObjectClass)
C25257 (NCI Thesaurus Property)
C0205390 (UMLS 2011AA Property)
CL.2
Code List
Treatment Phase
CL Item
Induction #1 (Induction #1)
CL Item
Induction #2 (Induction #2)
CL Item
Consolidation #1 (Consolidation #1)
CL Item
Consolidation #2 (Consolidation #2)
CL Item
Consolidation #3 (Consolidation #3)
CL Item
Consolidation #4 (Consolidation #4)
CL Item
Continuation (Continuation)
Item Group
Patient status assessment
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
Body Surface Area (m^2)
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
ProtocolTreatmentAdministeredInd-3
Item
Did the patient receive any protocol treatment?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C0442711 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
First Treatment (cycles 1 ¿ 6)
Item
Medication calendar completed by
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property-2)
C0013227 (UMLS 2011AA Property-2)
C19459 (NCI Thesaurus Property-3)
C1516147 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.4
Code List
Medication calendar completed by
CL Item
Patient (Patient)
CL Item
Other (Other)
PersonMedicationCalendarCompleteSpecify
Item
Specify
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property-2)
C0013227 (UMLS 2011AA Property-2)
C19459 (NCI Thesaurus Property-3)
C1516147 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
CapsuleAgentTakenTotalCount
Item
Number of capsules taken according to medication calendar
float
C25158 (NCI Thesaurus ObjectClass)
C0006935 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25701 (NCI Thesaurus Property)
C1883727 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
PillsReceivedCount
Item
Number of capsules dispensed
text
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
PillsRemainingCount
Item
Number of capsules returned
float
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25649 (NCI Thesaurus Property)
C1527428 (UMLS 2011AA Property)
Item
Reason for missed/reduced Midostaurin/Placebo dose
text
C753 (NCI Thesaurus ObjectClass)
C0032042 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C1728 (NCI Thesaurus ObjectClass-3)
C0538926 (UMLS 2011AA ObjectClass-3)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.5
Code List
Reason for missed/reduced Midostaurin/Placebo dose
CL Item
No Missed Doses (No missed doses)
CL Item
Pulmonary Toxicity (Pulmonary Toxicity)
C13304 (NCI Thesaurus)
C2709248 (UMLS 2011AA)
C27990 (NCI Thesaurus-3)
C0600688 (UMLS 2011AA-4)
CL Item
Cardiac Toxicity (Cardiac toxicity)
CL Item
Heme Toxicity (Heme toxicity)
CL Item
Other Non-heme Toxicity (Other non-heme toxicity)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
MidostaurinPlaceboAgentNotAdministeredSpecify
Item
Specify
text
C753 (NCI Thesaurus ObjectClass)
C0032042 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C1728 (NCI Thesaurus ObjectClass-3)
C0538926 (UMLS 2011AA ObjectClass-3)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Midostaurin/Placebo Dosing
Item
Time point
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
CL.10
Code List
Time point
CL Item
Day 1, Dose 1 (Day 1, Dose 1)
CL Item
Day 1, Dose 2 (Day 1, Dose 2)
CL Item
Day 3, Dose 1 (Day 3, Dose 1)
CL Item
Day 3, Dose 2 (Day 3, Dose 2)
CL Item
Day 5, Dose 1 (Day 5, Dose 1)
CL Item
Day 5, Dose 2 (Day 5, Dose 2)
ElectrocardiographyDiagnosticProcedureQTIntervalAssessmentValue
Item
QT interval
float
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C83501 (NCI Thesaurus Property-2)
C0429028 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
ElectrocardiographyDiagnosticProcedureQTcIntervalAssessmentValue
Item
QTc Interval
float
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C0489625 (NCI Metathesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
PatientVitalSignsHeartRatePhysicalExaminationValue
Item
Heart Rate
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C49672 (NCI Thesaurus Property-2)
C1704752 (UMLS 2011AA Property-2)
C49677 (NCI Thesaurus Property-3)
C0018810 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
ElectrocardiographyDiagnosticProcedurePRIntervalAssessmentValue
Item
PR interval
float
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C83502 (NCI Thesaurus Property-2)
C0429087 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
DiagnosticElectrocardiogramPerformedDate
Item
Date of EKG
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)
Item Group
Daunorubicin Dosing
Item
Time point
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
CL.10
Code List
Time point
CL Item
Day 1, Dose 1 (Day 1, Dose 1)
CL Item
Day 1, Dose 2 (Day 1, Dose 2)
CL Item
Day 3, Dose 1 (Day 3, Dose 1)
CL Item
Day 3, Dose 2 (Day 3, Dose 2)
CL Item
Day 5, Dose 1 (Day 5, Dose 1)
CL Item
Day 5, Dose 2 (Day 5, Dose 2)
DaunorubicinHydrochlorideAgentCurrentReportPeriodAdministeredTotalDose
Item
Daunorubicin dose received
float
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1583 (NCI Thesaurus ObjectClass-2)
C0282123 (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)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C0178602 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureTotalBilirubinResultUnspecifiedValue
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Cytarabine Dosing
Item
Time point
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
CL.10
Code List
Time point
CL Item
Day 1, Dose 1 (Day 1, Dose 1)
CL Item
Day 1, Dose 2 (Day 1, Dose 2)
CL Item
Day 3, Dose 1 (Day 3, Dose 1)
CL Item
Day 3, Dose 2 (Day 3, Dose 2)
CL Item
Day 5, Dose 1 (Day 5, Dose 1)
CL Item
Day 5, Dose 2 (Day 5, Dose 2)
CytosineArabinosideAgentCurrentReportPeriodAdministeredTotalDose
Item
Cytarabine Dose Received
float
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C408 (NCI Thesaurus ObjectClass-2)
C0010711 (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)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C0178602 (UMLS 2011AA ValueDomain-2)
Item Group
Cytarabine Dosing
Item
Time point
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
CL.10
Code List
Time point
CL Item
Day 1, Dose 1 (Day 1, Dose 1)
CL Item
Day 1, Dose 2 (Day 1, Dose 2)
CL Item
Day 3, Dose 1 (Day 3, Dose 1)
CL Item
Day 3, Dose 2 (Day 3, Dose 2)
CL Item
Day 5, Dose 1 (Day 5, Dose 1)
CL Item
Day 5, Dose 2 (Day 5, Dose 2)
CytosineArabinosideAgentCurrentReportPeriodAdministeredTotalDose
Item
Cytarabine Dose Received
float
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C408 (NCI Thesaurus ObjectClass-2)
C0010711 (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)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C0178602 (UMLS 2011AA ValueDomain-2)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Reason Treatment Ended
Item
Reason Treatment Ended (Mark one with an X.)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
CL.12
Code List
Reason Treatment Ended (Mark one with an X.)
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
Disease Progression Before Active Treatment (Disease Progression before active treatment)
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
Death On Study (Death on study)
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)
Off-TreatmentAdverseEventReasonSpecify
Item
Adverse event/side effects/complications specify (s)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property-2)
C0877248 (UMLS 2011AA Property-2)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
Off Treatment Reason, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
Item Group
Overall Response
Person Completing Form
Item
Completed by (print or type name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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