ID

1745

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

Versionen (2)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

19. September 2012

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

Englisch

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

1 Formulare  
Header Module
Beschreibung

Header Module

Date form originally completed
Beschreibung

FormOriginalCompleteDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25604
UMLS 2011AA Property
C0205313
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Date form amended
Beschreibung

FormAmendedCompleteDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Person amending form, last name
Beschreibung

ResponsiblePersonReportingChangeLastName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Initials
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Study ID
Beschreibung

PatientCoordinatingIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25462
UMLS 2011AA Property
C0700114
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Person Completing Form, Last Name
Beschreibung

ResponsiblePersonLastName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Ovarian Cancer Surgery
Beschreibung

Ovarian Cancer Surgery

Current Cycle Number
Beschreibung

TreatmentCurrentCourseNumber

Datentyp

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
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

text

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

text

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

IntraperitonealRouteofAdministrationMedicalDeviceReplacementInd-2

Datentyp

text

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

OffTreatmentIntraperitonealChemotherapyAdministeredInd-2

Datentyp

text

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
C15581
UMLS 2011AA ObjectClass
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
C15581
UMLS 2011AA ObjectClass
C0281548
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Grade
Beschreibung

CommonToxicityCriteriaAdverseEventReportingGrade

Datentyp

double

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
C25365
UMLS 2011AA Property
C0678257
Attempted port replacement
Beschreibung

IntraperitonealRouteofAdministrationMedicalDeviceAttemptReplacementInd-2

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C38258
UMLS 2011AA ObjectClass
C1522583
NCI Thesaurus Property
C16830
UMLS 2011AA Property
C0025080
NCI Thesaurus Property
C53610
UMLS 2011AA Property
C0559956
NCI Thesaurus Property
C39769
UMLS 2011AA Property
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
C15581
UMLS 2011AA ObjectClass
C0281548
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Footer Module
Beschreibung

Footer Module

Comments
Beschreibung

ResearchCommentsText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
FormOriginalCompleteDate
Item
Date form originally completed
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
FormAmendedCompleteDate
Item
Date form amended
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
ResponsiblePersonReportingChangeLastName
Item
Person amending form, last name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientCoordinatingIdentifierNumber
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
Item Group
Ovarian Cancer Surgery
TreatmentCurrentCourseNumber
Item
Current Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
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
Item
Were there complications related to the port
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C38258 (NCI Thesaurus ObjectClass)
C1522583 (UMLS 2011AA ObjectClass)
CL.1
Code List
Were there complications related to the port
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
CL.2
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))
Item
Cultures positive
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25300 (NCI Thesaurus Property)
C0430400 (UMLS 2011AA Property)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.3
Code List
Cultures positive
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
C1514241 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item
Access device replaced or revised
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16830 (NCI Thesaurus Property)
C0025080 (UMLS 2011AA Property)
C53610 (NCI Thesaurus Property)
C0559956 (UMLS 2011AA Property)
C38258 (NCI Thesaurus ObjectClass)
C1522583 (UMLS 2011AA ObjectClass)
CL.4
Code List
Access device replaced or revised
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was IP chemotherapy regimen stopped prematurely
text
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)
C0281548 (UMLS 2011AA ObjectClass)
CL.5
Code List
Was IP chemotherapy regimen stopped prematurely
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
C0281548 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.6
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)
Item
Grade
double
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)
C0678257 (UMLS 2011AA Property)
CL.7
Code List
Grade
CL Item
No Adverse Event Or Within Normal Limits (0)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
Attempted port replacement
text
C38258 (NCI Thesaurus ObjectClass)
C1522583 (UMLS 2011AA ObjectClass)
C16830 (NCI Thesaurus Property)
C0025080 (UMLS 2011AA Property)
C53610 (NCI Thesaurus Property)
C0559956 (UMLS 2011AA Property)
C39769 (NCI Thesaurus Property)
C1516084 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.8
Code List
Attempted port replacement
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
C0281548 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Footer Module
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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