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.

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
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
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
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Hospital No
Item
Patient Hospital No
text
C25337 (NCI Thesaurus ValueDomain)
C0421459 (UMLS CUI-1)
C16960 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C16696 (NCI Thesaurus ObjectClass)
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
Assessment of medication
Cycle Number
Item
Cycle number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
Item
Medications received during this reporting period (Mark one with an X)
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus ObjectClass-2)
C1514756 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Medications received during this reporting period (Mark one with an X)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Aspirin (Aspirin)
CL Item
Nsaid (NSAID)
CL Item
Anti-platelet (Anti-platelet)
CL Item
Statin (Statin)
CL Item
Bp Or Cardiac Medication (BP or cardiac medication)
CL Item
Anticoagulant (Anticoagulant)
NonsteroidalAntiinflammatoryDrugMedicationReportingPeriodSpecify
Item
NSAID, specify
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C257 (NCI Thesaurus ObjectClass-2)
C0003211 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AntiplateletMedicationReportingPeriodSpecify
Item
Anti-platelet, specify
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C1327 (NCI Thesaurus ObjectClass-2)
C0085826 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LipidLoweringMedicationReportingPeriodSpecify
Item
Statin, specify
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
CL264271 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
CardiacMedicationReportingPeriodSpecify
Item
BP or cardiac medication, specify
text
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AnticoagulantMedicationReportingPeriodSpecify
Item
Anticoagulant, specify
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C263 (NCI Thesaurus ObjectClass-2)
C0003280 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Which of the following arterial thrombotic events (ATEs) occurred during this reporting period? (Mark one with an X)
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C0221464 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Which of the following arterial thrombotic events (ATEs) occurred during this reporting period? (Mark one with an X)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Myocardial Infarction (Myocardial infarction)
C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)
CL Item
Angina (Angina)
C51221 (NCI Thesaurus)
C0002962 (UMLS 2011AA)
CL Item
Cva - Thrombotic (CVA - thrombotic)
CL Item
Cva - Hemorrhagic (CVA - hemorrhagic)
CL Item
Transient Ischemic Attack (Transient ischemic attack)
CL Item
Other Arterial Event (Other arterial event)
ArterialThrombosisReportingPeriodSpecify
Item
Other arterial event, specify
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C0221464 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Treatment for ATE (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C0221464 (NCI Metathesaurus ObjectClass)
CL.4
Code List
Treatment for ATE (Mark one with an X)
CL Item
Outpatient Management Only (Outpatient management only)
CL Item
Emergency Room (Emergency room)
CL Item
Hospitalization (Hospitalization)
Item
Outcome of ATE (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C0221464 (NCI Metathesaurus ObjectClass)
CL158230 (NCI Metathesaurus Property)
CL.5
Code List
Outcome of ATE (Mark one with an X)
CL Item
Resolved (Resolved)
C49498 (NCI Thesaurus)
C1709863 (UMLS 2011AA)
CL Item
Not Resolved (Not resolved)
CL Item
Resulted In Death (Resulted in death)
Item
Which of the following venous thrombotic events (VTEs) occurred during this reporting period? (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
CL.6
Code List
Which of the following venous thrombotic events (VTEs) occurred during this reporting period? (Mark one with an X)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Catheter Related (Catheter related)
CL Item
Dvt (DVT)
CL Item
Pulmonary Embolism (Pulmonary embolism)
CL Item
Other Venous Thrombotic Event (Other venous thrombotic event)
VenousThrombosisReportingPeriodSpecify
Item
Other venous thrombotic event, specify
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
VenousThrombosisPriorAnticoagulantInd-2
Item
Was the patient receiving anticoagulants prior to the VTEt?
boolean
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C263 (NCI Thesaurus Property-2)
C0003280 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
VenousThrombosisPriorAnticoagulantSpecify
Item
Yes, specify
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C263 (NCI Thesaurus Property-2)
C0003280 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
VenousThrombosisAnticoagulantTreatmentInd-2
Item
Were anticoagulants used to treate the VTE?
boolean
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C263 (NCI Thesaurus Property-2)
C0003280 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
VenousThrombosisAnticoagulantTreatmentSpecify
Item
Yes, specify
text
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C263 (NCI Thesaurus Property-2)
C0003280 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Treatment for VTE (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
C0087111 (NCI Metathesaurus Property)
CL.9
Code List
Treatment for VTE (Mark one with an X)
CL Item
Outpatient Management Only (Outpatient management only)
CL Item
Emergency Room (Emergency room)
CL Item
Hospitalization (Hospitalization)
Item
Outcome of VTE (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C25291 (NCI Thesaurus ObjectClass-2)
C0348013 (UMLS 2011AA ObjectClass-2)
CL158230 (NCI Metathesaurus Property)
CL.10
Code List
Outcome of VTE (Mark one with an X)
CL Item
Resolved (Resolved)
C49498 (NCI Thesaurus)
C1709863 (UMLS 2011AA)
CL Item
Not Resolved (Not resolved)
CL Item
Resulted In Death (Resulted in death)
Item
Did the patient experience an infusion reaction to cetuximab during the reporting period? (refer to CTCAE v. 3 Cytokine release syndrome/acute infusion reaction)
text
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
CL049508 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.11
Code List
Did the patient experience an infusion reaction to cetuximab during the reporting period? (refer to CTCAE v. 3 Cytokine release syndrome/acute infusion reaction)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Patient Did Not Receive Cetuximab (Patient did not receive cetuximab)
CetuximabInfusionReactionReportingPeriodSpecify
Item
Yes, specify grade (Report even on C-1399 Adverse Event Form.)
text
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
CL049508 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
InfusionSteroidTherapyAdministeredInd-2
Item
Were steroids given pre-infusion (including as an antiemetic?)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15388 (NCI Thesaurus ObjectClass)
C0574032 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C15370 (NCI Thesaurus ObjectClass-2)
C0149783 (UMLS 2011AA ObjectClass-2)
CollectedBloodInfusionReactionBiomarkerInd-2
Item
Was blood drawn for infusion reaction biomarkers?
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
C16342 (NCI Thesaurus Property)
C0005516 (UMLS 2011AA Property)
CL049508 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Treatment (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
C0087111 (NCI Metathesaurus Property)
CL049508 (NCI Metathesaurus ObjectClass)
CL.14
Code List
Treatment (Mark one with an X)
CL Item
Outpatient Management Only (Outpatient management only)
CL Item
Emergency Room (Emergency room)
CL Item
Hospitalization (Hospitalization)
Item
Outcome (Mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
CL049508 (NCI Metathesaurus ObjectClass)
CL158230 (NCI Metathesaurus Property)
CL.15
Code List
Outcome (Mark one with an X)
CL Item
Resolved (Resolved)
C49498 (NCI Thesaurus)
C1709863 (UMLS 2011AA)
CL Item
Not Resolved (Not resolved)
CL Item
Resulted In Death (Resulted in death)
CetuximabTreatmentPostInfusionReactionInd-2
Item
Was the patient retreated with cetuximab after the reaction?
boolean
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
C0087111 (NCI Metathesaurus ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
CL049508 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AcuteInfusionReactionRetreatmentInd-2
Item
If Yes, did the patient experience an acute infusion reaction upon retreatment?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C14140 (NCI Thesaurus ObjectClass)
C0205178 (UMLS 2011AA ObjectClass)
CL049508 (NCI Metathesaurus ObjectClass)
C0376495 (NCI Metathesaurus Property)
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date form completed
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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