ID

11924

Beschrijving

GOG-0241 Cycle Dose Drug Form (D2R) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Trefwoorden

  1. 18-12-14 18-12-14 - Martin Dugas
  2. 22-08-15 22-08-15 - Martin Dugas
Geüploaded op

22 augustus 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

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Cycle Dose Drug Form (D2R) GOG-0241

No Instruction available.

  1. StudyEvent: SE.0000
    1. No Instruction available.
Header Module
Beschrijving

Header Module

Date form originally completed (m d y)
Beschrijving

FormOriginalCompleteDate

Datatype

date

Date form amended (m d y)
Beschrijving

FormAmendedCompleteDate

Datatype

date

Person amending form, last name
Beschrijving

ResponsiblePersonReportingChangeLastName

Datatype

text

Patient Initials (First, Middle, Last)
Beschrijving

PatientInitialsName

Datatype

text

Patient Study ID
Beschrijving

PatientGynecologicOncologyGroupIdentifierNumber

Datatype

text

Person Completing Form, Last Name
Beschrijving

ResponsiblePersonLastName

Datatype

text

Comments
Beschrijving

ResearchCommentsText

Datatype

text

Treatment Cycle And Modification
Beschrijving

Treatment Cycle And Modification

Current Cycle Number
Beschrijving

TreatmentCurrentCourseNumber

Datatype

float

Cycle Delayed?
Beschrijving

TreatmentDelayedCycleInd-3

Datatype

boolean

Number of days treatment cycle was delayed
Beschrijving

TreatmentDelayDayCount

Datatype

float

Cycle delayed reason
Beschrijving

TreatmentDelayedCycleReason

Datatype

text

Cycle start date (Day 1 m d y)
Beschrijving

TreatmentCourseBeginDate

Datatype

date

Agent Name
Beschrijving

Agent Name

Datatype

text

Alias
UMLS CUI [1]
C1521826
Agent Dose level (e.g. 175 mg/m^2)
Beschrijving

AgentDoseLevelValue

Datatype

text

Dose modification status
Beschrijving

DoseModificationStatus

Datatype

text

Dose Modification (Change)
Beschrijving

DoseModificationInd

Datatype

text

Dose Modification Reason
Beschrijving

DoseModificationReason

Datatype

text

Adverse Event
Beschrijving

DoseAdverseEventModificationReason

Datatype

text

Agent Total Dose
Beschrijving

AgentCourseTotalDose

Datatype

float

Units (e.g. kgs)
Beschrijving

AgentDoseUOM

Datatype

text

Body weight
Beschrijving

Body weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Beschrijving

Body surface area

Datatype

float

Maateenheden
Alias
UMLS CUI [1]
C0005902
ECOG performance status grade
Beschrijving

ECOG performance status grade

Datatype

integer

Alias
UMLS CUI [1]
C1632812
Pretreatment Hematology And Chemistry Values
Beschrijving

Pretreatment Hematology And Chemistry Values

Assessment Date (m d y)
Beschrijving

LesionAssessmentDate

Datatype

date

Hemoglobin
Beschrijving

Hemoglobin

Datatype

float

Maateenheden
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Peripheral Hematocrit Count (1000/L)
Beschrijving

LaboratoryProcedureErythrocyteResultCount

Datatype

float

WBC
Beschrijving

WBC

Datatype

float

Maateenheden
  • /ul
Alias
UMLS CUI [1]
C0023508
/ul
ANC
Beschrijving

ANC

Datatype

float

Maateenheden
  • 1000/ul
Alias
UMLS CUI [1]
C0200633
1000/ul
Peripheral Platelet Count
Beschrijving

Peripheral Platelet Count

Datatype

float

Maateenheden
  • 1000/uL
Alias
UMLS CUI [1]
C0005821
1000/uL
PT (sec)
Beschrijving

LaboratoryProcedureProthrombinTimeResultValue

Datatype

float

Maateenheden
  • seconds
seconds
PTT
Beschrijving

PTT

Datatype

float

Maateenheden
  • seconds
Alias
UMLS CUI [1]
C0030605
seconds
UPCR
Beschrijving

UrinaryCreatinineProteinAssessmentValue

Datatype

float

BUN
Beschrijving

BUN

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0005845
mg/dL
Creatinine
Beschrijving

Creatinine

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Creatinine Clearance
Beschrijving

Creatinine Clearance

Datatype

float

Maateenheden
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
AST (SGOT)
Beschrijving

AST (SGOT)

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
Bilirubin, total
Beschrijving

Bilirubin, total

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
Alkaline Phosphatase
Beschrijving

Alkaline Phosphatase

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Result of CA125 (IU/ml)
Beschrijving

LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

Datatype

float

INR
Beschrijving

INR

Datatype

float

Alias
UMLS CUI [1]
C0525032
Other, specify test
Beschrijving

LaboratoryProcedureSecondOptionalPerformedSpecify

Datatype

text

Other specify value
Beschrijving

LaboratoryProcedurePerformedValue

Datatype

float

Similar models

No Instruction available.

  1. StudyEvent: SE.0000
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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