ID

8512

Beschreibung

GOG-0252 Port Complications (Form PCF) Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6362EF9C-F4F7-7D80-E040-BB89AD433D31

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6362EF9C-F4F7-7D80-E040-BB89AD433D31

Stichworte

  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Fallopian Tube Cancer NCT00951496 Toxicity - GOG-0252 Port Complications (Form PCF) - 2840248v1.0

Summarize port complications which occurred during delivery of this cycle of IP therapy or caused a delay or missed IP cycle.

Header Module
Beschreibung

Header Module

Date form originally completed
Beschreibung

Form Completion Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Date form amended
Beschreibung

Amendment date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C0680532
NCI Thesaurus Property
C25250
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C25416
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Person amending form, last name
Beschreibung

Person Amending Form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1547383
NCI Thesaurus Property
C25364
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Study ID
Beschreibung

Patient Study ID

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Person Completing Form, Last Name
Beschreibung

Person Completing Form Last Name

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
Ovarian Cancer Surgery
Beschreibung

Ovarian Cancer Surgery

Current Cycle Number
Beschreibung

Cycle Number Chemotherapeutics

Datentyp

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25379
Date of complication
Beschreibung

IntraperitonealRouteofAdministrationAdverseEventDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C38258
UMLS 2011AA ObjectClass
C1522583
Port Complications
Beschreibung

Port Complications

Were there complications related to the port
Beschreibung

IntraperitonealRouteofAdministrationAdverseEventInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C38258
UMLS 2011AA ObjectClass
C1522583
Were there complications related to the port
Beschreibung

IntraperitonealRouteofAdministrationAdverseEventType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C38258
UMLS 2011AA ObjectClass
C1522583
Cultures positive
Beschreibung

SurgicalProcedureCultureProcedurePositiveFindingComplicationInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C25300
UMLS 2011AA Property
C0430400
NCI Thesaurus Property-2
C38758
UMLS 2011AA Property-2
C1514241
NCI Thesaurus Property-3
C2959
UMLS 2011AA Property-3
C0009566
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Organism (was)
Beschreibung

SurgicalProcedureCultureProcedurePositiveFindingComplicationText

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C25300
UMLS 2011AA Property
C0430400
NCI Thesaurus Property-2
C38758
UMLS 2011AA Property-2
C1514241
NCI Thesaurus Property-3
C2959
UMLS 2011AA Property-3
C0009566
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Access device replaced or revised
Beschreibung

IntraperitonealRouteofAdministrationMedicalDeviceReplacementInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C16830
UMLS 2011AA Property
C0025080
NCI Thesaurus Property-2
C53610
UMLS 2011AA Property-2
C0559956
NCI Thesaurus ObjectClass
C38258
UMLS 2011AA ObjectClass
C1522583
Was IP chemotherapy regimen stopped prematurely
Beschreibung

OffTreatmentIntraperitonealChemotherapyAdministeredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass-2
C15581
UMLS 2011AA ObjectClass-2
C0281548
Was IP chemotherapy regimen stopped prematurely
Beschreibung

OffTreatmentIntraperitonealChemotherapyReason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus ObjectClass-2
C15581
UMLS 2011AA ObjectClass-2
C0281548
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Grade
Beschreibung

CommonToxicityCriteriaAdverseEventReportingGrade

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Attempted port replacement
Beschreibung

IntraperitonealRouteofAdministrationMedicalDeviceAttemptReplacementInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C38258
UMLS 2011AA ObjectClass
C1522583
NCI Thesaurus Property
C16830
UMLS 2011AA Property
C0025080
NCI Thesaurus Property-2
C53610
UMLS 2011AA Property-2
C0559956
NCI Thesaurus Property-3
C39769
UMLS 2011AA Property-3
C1516084
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Other specify
Beschreibung

OffTreatmentIntraperitonealChemotherapyReasonSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus ObjectClass-2
C15581
UMLS 2011AA ObjectClass-2
C0281548
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Footer Module
Beschreibung

Footer Module

Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393

Ähnliche Modelle

Summarize port complications which occurred during delivery of this cycle of IP therapy or caused a delay or missed IP cycle.

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
Form Completion Date
Item
Date form originally completed
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Amendment date
Item
Date form amended
date
C19464 (NCI Thesaurus ObjectClass)
C0680532 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Person Amending Form
Item
Person amending form, last name
text
C25191 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1547383 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Person Completing Form Last Name
Item
Person Completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Item Group
Ovarian Cancer Surgery
Cycle Number Chemotherapeutics
Item
Current Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)
IntraperitonealRouteofAdministrationAdverseEventDate
Item
Date of complication
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C38258 (NCI Thesaurus ObjectClass)
C1522583 (UMLS 2011AA ObjectClass)
Item Group
Port Complications
IntraperitonealRouteofAdministrationAdverseEventInd-2
Item
Were there complications related to the port
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C38258 (NCI Thesaurus ObjectClass)
C1522583 (UMLS 2011AA ObjectClass)
Item
Were there complications related to the port
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C38258 (NCI Thesaurus ObjectClass)
C1522583 (UMLS 2011AA ObjectClass)
Code List
Were there complications related to the port
CL Item
Abdominal Pain Sufficient To Prevent Treatment (Abdominal pain sufficient to prevent treatment)
CL Item
Abscess In Abdomen Or Pelvis By Ct Or Surgically Drained (Abscess in abdomen or pelvis by CT or surgically drained)
CL Item
Bowel Complication Not Requiring Surgery (Bowel complication not requiring surgery)
CL Item
Bowel Complication Requiring Surgery (Bowel complication requiring surgery)
CL Item
Cellutitis Surrounding Port (Cellutitis surrounding port)
CL Item
Dyspnea With Ip Chemotherapy Infusion (Dyspnea with IP chemotherapy infusion)
CL Item
Fever, Abdominal Pain, And Hospitalization Suspected To Be Peritonitis (Fever, abdominal pain, and hospitalization suspected to be peritonitis)
CL Item
Leaking Of Ascites Or Chemotherapy Out Vagina Or Wound (Leaking of ascites or chemotherapy out vagina or wound)
CL Item
Reflux Of Fluid Or Leaking Of Fluid Around Port Pocket (Reflux of fluid or leaking of fluid around port pocket)
CL Item
Removal Of Port Required (Removal of port required)
CL Item
Unable To Access Port With Huber Needle (Unable to access port with huber needle)
CL Item
Unable To Infuse Ip Chemotherapy (i.e., Blocked Catheter) (Unable to infuse IP chemotherapy (i.e., blocked catheter))
SurgicalProcedureCultureProcedurePositiveFindingComplicationInd-2
Item
Cultures positive
boolean
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25300 (NCI Thesaurus Property)
C0430400 (UMLS 2011AA Property)
C38758 (NCI Thesaurus Property-2)
C1514241 (UMLS 2011AA Property-2)
C2959 (NCI Thesaurus Property-3)
C0009566 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SurgicalProcedureCultureProcedurePositiveFindingComplicationText
Item
Organism (was)
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25300 (NCI Thesaurus Property)
C0430400 (UMLS 2011AA Property)
C38758 (NCI Thesaurus Property-2)
C1514241 (UMLS 2011AA Property-2)
C2959 (NCI Thesaurus Property-3)
C0009566 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
IntraperitonealRouteofAdministrationMedicalDeviceReplacementInd-2
Item
Access device replaced or revised
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16830 (NCI Thesaurus Property)
C0025080 (UMLS 2011AA Property)
C53610 (NCI Thesaurus Property-2)
C0559956 (UMLS 2011AA Property-2)
C38258 (NCI Thesaurus ObjectClass)
C1522583 (UMLS 2011AA ObjectClass)
OffTreatmentIntraperitonealChemotherapyAdministeredInd-2
Item
Was IP chemotherapy regimen stopped prematurely
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C15581 (NCI Thesaurus ObjectClass-2)
C0281548 (UMLS 2011AA ObjectClass-2)
Item
Was IP chemotherapy regimen stopped prematurely
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15581 (NCI Thesaurus ObjectClass-2)
C0281548 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Was IP chemotherapy regimen stopped prematurely
CL Item
Abdominal Pain (Abdominal pain)
CL Item
Bowel Complication (Bowel complication)
CL Item
Disease Progression (Disease progression)
C17747 (NCI Thesaurus)
C0242656 (UMLS 2011AA)
CL Item
Fluid Out Vagina Or Wound (Fluid out vagina or wound)
CL Item
Nausea/vomiting/dehydration (Nausea/vomiting/dehydration)
CL Item
Neuropathy (Neuropathy)
C4731 (NCI Thesaurus)
C0031117 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Refusal (Patient refusal)
CL Item
Port Complication (Port complication)
CL Item
Renal/metabolic (Renal/metabolic)
CommonToxicityCriteriaAdverseEventReportingGrade
Item
Grade
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
IntraperitonealRouteofAdministrationMedicalDeviceAttemptReplacementInd-2
Item
Attempted port replacement
boolean
C38258 (NCI Thesaurus ObjectClass)
C1522583 (UMLS 2011AA ObjectClass)
C16830 (NCI Thesaurus Property)
C0025080 (UMLS 2011AA Property)
C53610 (NCI Thesaurus Property-2)
C0559956 (UMLS 2011AA Property-2)
C39769 (NCI Thesaurus Property-3)
C1516084 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
OffTreatmentIntraperitonealChemotherapyReasonSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15581 (NCI Thesaurus ObjectClass-2)
C0281548 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Footer Module
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

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