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. mg/m^2)
text
Item
Were there any dose modifications or additions/omissions to protocol treatment (1=Yes, planned; 2 =Yes, unplanned; 3=No)
text
Code List
Were there any dose modifications or additions/omissions to protocol treatment (1=Yes, planned; 2 =Yes, unplanned; 3=No)
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)
AgentCourseTotalDose
Item
Total dose of agents/drugs for this cycle
double
AgentDoseUOM
Item
Units (eg. mg, kg)
text
PatientWeightMeasurement
Item
Patient weight (kg)
double
PersonBodySurfaceAreaValue
Item
Body Surface Area (m^2)
double
Item
Performance status (Zubrod)
text
Code List
Performance status (Zubrod)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
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 (mm3)
double
LaboratoryProcedurePlateletResultSpecifiedValue
Item
Peripheral Platelet Count (mm3)
double
LaboratoryProcedureProthrombinTimeResultValue
Item
PT (sec)
double
LaboratoryProcedurePartialThromboplastinTimeResultValue
Item
PTT (sec) (sec)
double
LaboratoryProcedureBloodUreaNitrogenResultUnspecifiedValue
Item
BUN (mg/dl)
double
LaboratoryProcedureCreatinineResultSpecifiedValue
Item
Creatinine (mg/dl)
double
LaboratoryProcedureCreatinineClearanceOutcomeValue
Item
Creatinine Clearance (ml/min)
double
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue
Item
SGOT
double
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin
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