ID

8187

Description

Gynecologic Oncology Group Follow-Up Period Adverse Event Reporting Form (TLC) Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=644E86D7-E1C5-D7C8-E040-BB89AD4321CC

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=644E86D7-E1C5-D7C8-E040-BB89AD4321CC

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Endometrial Cancer NCT00942357 Toxicity - Gynecologic Oncology Group Follow-Up Period Adverse Event Reporting Form (TLC) - 2845009v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: Gynecologic Oncology Group Follow-Up Period Adverse Event Reporting Form (TLC)
    1. No Instruction available.
Header Module
Description

Header Module

Date form originally completed (m d y)
Description

Form Completion Date

Data type

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 (m d y)
Description

Amendment date

Data type

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
Description

Person Amending Form

Data type

text

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

Patient Initials

Data type

text

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

Patient ID GOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512288
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25521
Person Completing Form, Last Name
Description

Person Completing Form Last Name

Data type

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
Adverse Events - Section 1
Description

Adverse Events - Section 1

Reporting Period
Description

Clinical Trial Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Are there any adverse events to report
Description

AdverseEventNewPeriodicReportInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property-2
C25375
UMLS 2011AA Property-2
C0684224
NCI Metathesaurus Property
CL158136
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Date of Most Recent Adverse Event Assessment (m d y)
Description

AdverseEventMostRecentAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C25577
UMLS 2011AA Property-2
C1513491
Was patient hospitalized as a result of reported adverse events? (during this reporting period)
Description

Hospitalization

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0019993
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus ObjectClass-2
C25182
NCI Thesaurus Property
C25385
Adverse Events - Section 3
Description

Adverse Events - Section 3

CTC Adverse Event Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Grade
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
SAE report submitted
Description

SAE report

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1519255
NCI Thesaurus ObjectClass
C41331
UMLS CUI-2
C0684224
NCI Thesaurus Property
C25375
NCI Thesaurus ObjectClass-2
C54035
AE Onset Date
Description

Adverse Event Onset Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985916
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25279
Present Status
Description

AdverseEventContinueStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C53279
UMLS 2011AA Property
C0549178
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Comments
Description

Comments

COMMENTS
Description

Research Comments

Data type

text

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

No Instruction available.

1 forms
  1. StudyEvent: Gynecologic Oncology Group Follow-Up Period Adverse Event Reporting Form (TLC)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Form Completion Date
Item
Date form originally completed (m d y)
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 (m d y)
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 ID GOG
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512288 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25521 (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
Adverse Events - Section 1
Clinical Trial Period
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
Item
Are there any adverse events to report
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property-2)
CL158136 (NCI Metathesaurus Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.1
Code List
Are there any adverse events to report
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Patient Not Evaluated (Patient not evaluated)
AdverseEventMostRecentAssessmentDate
Item
Date of Most Recent Adverse Event Assessment (m d y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
Hospitalization
Item
Was patient hospitalized as a result of reported adverse events? (during this reporting period)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0019993 (UMLS CUI-1)
C16696 (NCI Thesaurus ObjectClass)
C25182 (NCI Thesaurus ObjectClass-2)
C25385 (NCI Thesaurus Property)
Item Group
Adverse Events - Section 3
CTC Adverse Event Term
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.3
Code List
CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
SAE report
Item
SAE report submitted
boolean
C38148 (NCI Thesaurus ValueDomain)
C1519255 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass)
C0684224 (UMLS CUI-2)
C25375 (NCI Thesaurus Property)
C54035 (NCI Thesaurus ObjectClass-2)
Adverse Event Onset Date
Item
AE Onset Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985916 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
Item
Present Status
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C53279 (NCI Thesaurus Property)
C0549178 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.5
Code List
Present Status
CL Item
Fatal Or Died (Fatal/Died)
CL Item
Intervention For Adverse Event Continues (Intervention for AE Continues)
CL Item
Ae Status Not Evaluated (AE status not evaluated)
CL Item
Not Recovered Or Not Resolved (Not recovered/Not resolved)
C49494 (NCI Thesaurus)
C1709277 (UMLS 2011AA)
CL Item
Recovered Or Resolved With Sequelae (Recovered/Resolved with Sequelae)
C49495 (NCI Thesaurus)
C1709862 (UMLS 2011AA)
CL Item
Recovered Or Resolved Without Sequelae (Recovered/Resolved without Sequelae)
C85257 (NCI Thesaurus)
C2827606 (UMLS 2011AA)
CL Item
Recovering Or Resolving (Recovering/Resolving)
C49496 (NCI Thesaurus)
C1709864 (UMLS 2011AA)
Item Group
Comments
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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