FormOriginalCompleteDate
Item
Date form originally completed (m d y)
date
FormAmendedCompleteDate
Item
Date form amended (m d y)
date
ResponsiblePersonReportingChangeLastName
Item
Person amending form, last name
text
PatientInitialsName
Item
Patient Initials (First, Middle, Last)
text
PatientGynecologicOncologyGroupIdentifierNumber
Item
Patient Study ID
text
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
TreatmentCurrentCourseNumber
Item
Current Cycle Number
double
TreatmentDelayDayCount
Item
Number of days treatment cycle was delayed
double
Item
Cycle delayed reason
text
Code List
Cycle delayed reason
CL Item
Non Protocol Illness (Non protocol illness)
CL Item
Patient Refusal (Patient refusal)
CL Item
Personal Reasons (Personal reasons)
CL Item
Protocol Related Ae (Protocol related AE)
CL Item
Scheduling (Scheduling)
TreatmentCourseBeginDate
Item
Cycle start date (Day 1 m d y)
date
AgentName
Item
Agent name (Drug)
text
AgentDoseLevelValue
Item
Agent Dose level (e.g. 175 mg/m^2)
text
DoseModificationStatus
Item
Dose modification status
text
Item
Dose Modification (Change)
text
Code List
Dose Modification (Change)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
DoseModificationReason
Item
Dose Modification Reason
text
DoseAdverseEventModificationReason
Item
Adverse Event
text
AgentCourseTotalDose
Item
Agent Total Dose
double
AgentDoseUOM
Item
Units (e.g. kgs)
text
PatientWeightMeasurement
Item
Patient weight (kg)
double
PersonBodySurfaceAreaValue
Item
Body Surface Area (m^2)
double
PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale
Item
Performance status (Zubrod)
text
LesionAssessmentDate
Item
Assessment Date (m d y)
date
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin
double
LaboratoryProcedureErythrocyteResultCount
Item
Peripheral Hematocrit Count (1000/L)
double
LaboratoryProcedureLeukocyteResultSpecifiedValue
Item
Peripheral WBC Count (mm3)
double
LaboratoryProcedureGranulocyteResultCount
Item
Peripheral Granulocytes Count (ANC mm3)
double
LaboratoryProcedurePlateletResultSpecifiedValue
Item
Peripheral Platelet Count (mm3)
double
LaboratoryProcedureProthrombinTimeResultValue
Item
PT (sec)
double
LaboratoryProcedurePartialThromboplastinTimeResultValue
Item
PTT (sec) (sec)
double
UrinaryCreatinineProteinAssessmentValue
Item
UPCR
double
LaboratoryProcedureBloodUreaNitrogenResultUnspecifiedValue
Item
BUN (mg/dl)
double
LaboratoryProcedureCreatinineResultSpecifiedValue
Item
Creatinine (mg/dl)
double
LaboratoryProcedureCreatinineClearanceOutcomeValue
Item
Creatinine Clearance (ml/min)
double
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue
Item
SGOT (IU/ml)
double
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin (mg %)
double
LaboratoryProcedureAlkalinePhosphataseResultValue
Item
Alkaline Phosphatase
double
LaboratoryProcedureCA-125AntigenTumorMarkerResultValue
Item
Result of CA125 (IU/ml)
double
LaboratoryProcedureInternationalNormalizationRatioResultValue
Item
International Normalization Ratio (INR)
double
LaboratoryProcedureSecondOptionalPerformedSpecify
Item
Other, specify test
text
LaboratoryProcedurePerformedValue
Item
Other specify value
double