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  1. StudyEvent: SE.0000
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
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
ResearchCommentsText
Item
Comments
text
Item Group
Treatment Cycle And Modification
TreatmentCurrentCourseNumber
Item
Current Cycle Number
float
TreatmentDelayedCycleInd-3
Item
Cycle Delayed?
boolean
TreatmentDelayDayCount
Item
Number of days treatment cycle was delayed
float
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
Agent
Item
Agent Name
text
C1521826 (UMLS CUI [1])
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)
CL Item
No (No)
DoseModificationReason
Item
Dose Modification Reason
text
DoseAdverseEventModificationReason
Item
Adverse Event
text
AgentCourseTotalDose
Item
Agent Total Dose
float
AgentDoseUOM
Item
Units (e.g. kgs)
text
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
BSA
Item
Body surface area
float
C0005902 (UMLS CUI [1])
Item
ECOG performance status grade
integer
C1632812 (UMLS CUI [1])
Code List
ECOG performance status grade
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0) (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) (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) (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3) (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4) (4)
CL Item
Dead (5) (5)
Item Group
Pretreatment Hematology And Chemistry Values
LesionAssessmentDate
Item
Assessment Date (m d y)
date
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
LaboratoryProcedureErythrocyteResultCount
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])
LaboratoryProcedureProthrombinTimeResultValue
Item
PT (sec)
float
PTT
Item
PTT
float
C0030605 (UMLS CUI [1])
UrinaryCreatinineProteinAssessmentValue
Item
UPCR
float
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])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
LaboratoryProcedureCA-125AntigenTumorMarkerResultValue
Item
Result of CA125 (IU/ml)
float
INR
Item
INR
float
C0525032 (UMLS CUI [1])
LaboratoryProcedureSecondOptionalPerformedSpecify
Item
Other, specify test
text
LaboratoryProcedurePerformedValue
Item
Other specify value
float

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