Reporter_information
PersonCompletingForm,FirstName
text
Person Completing Form Last Name
text
PersonMiddleName
text
Person Completing Form Phone
text
ResponsiblePersonE-mailAddressText
text
ResponsiblePersonFaxNumber
text
Physician_information
TreatingMDFirstName
text
TreatingMDLastName
text
PersonMiddleName
text
TreatingMDPhone
text
TreatingPhysicianE-mail
text
TreatingPhyisicanFaxNumber
text
Submitter_information
SubmittedByFirstName
text
SubmittedByLastName
text
PersonMiddleName
text
Person Completing Form Phone
text
ResponsiblePersonE-mailAddressText
text
PersonFaxNumber
text
Course_information
TreatmentAssignmentCode
text
DESCRIPTION
text
TreatmentAssignment
text
CourseStartDate
date
StartDateofcourseassociatedwithExpedited
text
StartDateofPrimaryAE
text
EndDateofPrimaryAE
text
CourseNumberonwhichAEoccurred
text
AgentCourseCount
float
Description_of_event
DescriptionandTreatmentofEvent(s)
text
AdverseEventStatusText
text
Recoveryordeathdate
text
Retreated
text
RemovedfromProtocolTreatment
text
Off-TreatmentStudyFollow-UpEndDate
date
PatientCauseofDeathText
text
PrimaryOrganSystemfailureCausingDeath
text
DeathDocumentedDate
date
AutopsyPerformed
text
Institution_information
Institution Name
text
CTEPID
text
Institution Number
text
Protocol_information
Protocol ID NCI
text
Protocol Title
text
Phase
text
CurrentProtocolStatus
text
TypeofStudy
text
LeadInstitution
text
PrincipalInvestigatorName
text
LeadDrugMonitor
text
CTCAEVersion
text
Protocol ID NCI
text
Patient_information
Patient'sIDNumber
text
Patient Birth Date
date
PatientRaceCategory
text
PatientGenderCategory
text
PatientEthnicityCategory
text
Patient Height
float
Patient Weight
float
PerformanceStatusScale
text
DiseaseName
text
DiseaseCategory
text
DiseaseNameNotListed
text
PrimarySiteofDisease
text
CancerInitialDiagnosisDate
date
OtherPrimarySiteofDisease
text
Prior_therapy
Therapy Modification
text
Treatment Start Date
date
Treatment End Date
date
Research Comments
text
Chemoagents
Pre_existing_condition
Site_name
Protocol_agent
Agent
text
AgentNSC/GPIIdentifierNumber
text
Agent Total Dose
float
DateofLastAdministrationpriortoSAE
text
Units
text
Research Comments
text
AgentAdjustment
text
DoseDelayedInd-3
boolean
Delay
text
DelayUOM
text
Concomitant_medication
Other_contributing_cause
Adverse_event_ctc
Category
text
CommonToxicityCriteriaAdverseEventTermType
text
MedDRACode
text
CommonToxicityCriteriaAdverseEventGrade
float
CommonToxicityCriteriaAdverseEventTermType
text
CommonToxicityCriteriaAdverseEventTermType
text
CTCAdverseEventCategory
text
CommonToxicityCriteriaAdverseEventTermType
text
MedDRACode
text
CommonToxicityCriteriaAdverseEventGrade
float
CTCAdverseEventTerm,Specify
text
Hospitalization or Prolongation of Hospitalization
boolean
Research Comments
text
AE_REPORTED_BY
text
LATEST_VERSION_GRADE_ID
text
Attribution_for_ae
ATTRIBUTED_TO_TYPE
text
ATTRIBUTED_TO
text
ATTRIBUTED_TO_BY
text
CTCAdverseEventAttributionScale
text
AttributionBy
text
Lab_result
LabCategory
text
Lab
text
OtherLab
text
BaselineDate
text
BaselineValue
text
AssessmentLabUOM
text
RecoveryLatestDate
text
RecoveryLatestValue
text
RecoveryLatestUOM
text
WorstDate
text
WorstValue
text
WorstUOM
text
Site
text
Microbiology Date
date
InfectiousAgentName
text
Additional_info
AdditionalInformation
text