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
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CourseDelayDayCount
Item
Number of days treatment course was delayed
double
AgentName
Item
Agent name (Drug)
text
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)
C0441889 (UMLS 2011AA Property)
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
double
AgentDoseUnits
Item
Units
text
PatientWeight
Item
Patient weight (kg)
double
BodySurfaceArea
Item
Body surface area (m2)
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
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
Lab,Hematology,Hemoglobin
Item
Hemoglobin
double
Lab,Hematology,HematocritCount
Item
Peripheral hematocrit count (1000/L)
double
Lab,Hematology,WBC
Item
Peripheral WBC count (mm3)
double
Lab,Hematology,GranulocyteCount
Item
Peripheral granulocytes count (mm3)
double
Lab,Hematology,Platelets
Item
Peripheral platelet count (mm3)
double
Lab,Renal,BUN
Item
BUN (mg/dl)
double
Lab,Renal,Creatinine
Item
Creatinine (mg/dl)
double
Lab,Renal,CreatinineClearance
Item
Creatinine Clearance (ml/min)
double
Lab,Hepatic,SGOT
Item
SGOT (IU/ml)
double
Lab,Hepatic,Bilirubin
Item
Bilirubin (mg %)
double
TumorMarker,CA125Result
Item
Result of CA125 (IU/ml)
double
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)
C1279901 (UMLS 2011AA Property)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LaboratoryProcedureFirstOptionalPerformedValue
Item
Other (1st Lab Value), specify
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
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)
C0205436 (UMLS 2011AA Property)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSecondOptionalPerformedValue
Item
Other (2nd Lab Value), specify
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
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
double
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)
C0600091 (UMLS 2011AA Property)