FormCompletionDate,Original
Item
Date form originally completed (m d y)
date
FormCompletionDate,Amended
Item
Date form amended (m d y)
date
ResponsiblePersonReportingChangeLastName
Item
Person amending form, last name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientName,Last
Item
Patient Name, Last
text
PatientName,First
Item
Patient Name, First
text
PatientStudyID
Item
Patient Study ID
text
PersonCompletingForm,LastName
Item
Person Completing Form, Last Name
text
CourseBeginDate
Item
Cycle start date (Day 1 m d y)
date
CourseIdentification
Item
Current cycle number
text
CycleDelayedInd
Item
Cycle delayed
boolean
CourseDelayDayCount
Item
Number of days treatment course was delayed
float
Agent
Item
Agent Name
text
C1521826 (UMLS CUI [1])
AgentDoseLevelValue
Item
Dose level
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)
Item
Dose modification (change) (* P = Planned, U = Unplanned)
text
Code List
Dose modification (change) (* P = Planned, U = Unplanned)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Planned)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Unplanned)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
AgentTotalDose(percourse)
Item
Total dose of agents/drugs for this cycle
float
AgentDoseUnits
Item
Units
text
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
BSA
Item
Body surface area
float
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI [1])
Item
Performance status
text
Code List
Performance status
CL Item
Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90 - 100) (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90 - 100))
CL Item
Restricted in physically strenuous activity but ambulatory (K 70 - 80) (Restricted in physically strenuous activity but ambulatory (K 70 - 80))
CL Item
Completely disabled (K 10 - 20) (Completely disabled (K 10 - 20))
CL Item
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30 - 40) (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30 - 40))
CL Item
Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50 - 60) (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50 - 60))
AssessmentDate
Item
Assessment date (m d y Pretreatment hematology and chemistry values Specify individual dates when assessment dates differ)
date
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Lab,Hematology,HematocritCount
Item
Peripheral hematocrit count (1000/L)
float
Leukocytes (WBC)
Item
WBC
float
C0023508 (UMLS CUI [1])
Neutrophil count
Item
ANC
float
C0200633 (UMLS CUI [1])
Platelets
Item
Peripheral Platelet Count
float
C0005821 (UMLS CUI [1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
Creatinine, Serum
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
Bilirubin, total
Item
Bilirubin, total
float
C0201913 (UMLS CUI [1])
TumorMarker,CA125Result
Item
Result of CA125 (IU/ml)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
LaboratoryProcedureFirstOptionalPerformedSpecify
Item
Other (1st Lab Test), specify
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C25603 (NCI Thesaurus Property-3)
C1518600 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LaboratoryProcedureFirstOptionalPerformedValue
Item
Other (1st Lab Value), specify
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C25603 (NCI Thesaurus Property-3)
C1518600 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSecondOptionalPerformedSpecify
Item
Other (2nd Lab Test), specify
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25666 (NCI Thesaurus Property-2)
C0205436 (UMLS 2011AA Property-2)
C25603 (NCI Thesaurus Property-3)
C1518600 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSecondOptionalPerformedValue
Item
Other (2nd Lab Value), specify
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25666 (NCI Thesaurus Property-2)
C0205436 (UMLS 2011AA Property-2)
C25603 (NCI Thesaurus Property-3)
C1518600 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
ParticipatingGroupCode
Item
Participating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
ParticipatingGroupProtocolNumber
Item
Participating Group Protocol Number
float
PatientParticipatingIdentifierNumber
Item
Participating Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property-2)
C0600091 (UMLS 2011AA Property-2)