ID

9529

Description

Z1031: Adverse Events Form Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FAD7AE3C-C9A3-1CD3-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FAD7AE3C-C9A3-1CD3-E034-0003BA3F9857

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 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 NCT00265759 Toxicity - Z1031: Adverse Events Form - 2316417v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: Z1031: Adverse Events Form
    1. No Instruction available.
Header Module
Description

Header Module

Visit
Description

AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C19712
UMLS 2011AA ObjectClass
C1515944
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Patient ID (Pt. ID issued during registration or previously issued Patient ID)
Description

Patient Study ID

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Institution No.
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Patient Initials (F M L)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Instructions
Description

Instructions

Date of Symptom/Event Assessment
Description

AdverseEventAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Was patient hospitalized during this reporting interval
Description

HospitalizationReportPeriodInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25375
UMLS 2011AA Property-2
C0684224
NCI Thesaurus ObjectClass
C25179
UMLS 2011AA ObjectClass
C0019993
Has an Adverse Event Expedited (AdEERS) Report been submitted
Description

AdverseEventReportInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass-2
C17648
UMLS 2011AA ObjectClass-2
C0439064
Ae Module
Description

Ae Module

Common Toxicity Criteria Adverse Event Term Type
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
Not Assessed
Description

AdverseEventNoAssessmentText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C25217
UMLS 2011AA Property-2
C1516048
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
CTC Adverse Event Grade (1-5)
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
Not present
Description

AdverseEventAbsentText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48190
UMLS 2011AA Property
C0332197
CTC AE Attribution Code (see above)
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
Header
Description

Header

Check box if no additional adverse events were experienced by patient
Description

AdverseEventNegativeAssessmentText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C38757
UMLS 2011AA Property-2
C1513916
Other Ae Module
Description

Other Ae Module

CTC Adverse Event Term Specify
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Grade (1-5)
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 AE Attribution Code (see above)
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
Completed by
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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No Instruction available.

1 forms
  1. StudyEvent: Z1031: Adverse Events Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Item
Visit
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
CL.1
Code List
Visit
CL Item
Day 1 (Day 1)
CL Item
Week 4 (Week 4)
CL Item
Week 8 (Week 8)
CL Item
Week 12 (Week 12)
CL Item
Week 15 (Week 15)
CL Item
Week 16 (Week 16)
CL Item
Surgery (Surgery)
CL Item
30 Days Post Surgery (30 days post surgery)
Patient Study ID
Item
Patient ID (Pt. ID issued during registration or previously issued Patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials (F M L)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Item Group
Instructions
AdverseEventAssessmentDate
Item
Date of Symptom/Event Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
HospitalizationReportPeriodInd-2
Item
Was patient hospitalized during this reporting interval
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property-2)
C25179 (NCI Thesaurus ObjectClass)
C0019993 (UMLS 2011AA ObjectClass)
AdverseEventReportInd-3
Item
Has an Adverse Event Expedited (AdEERS) Report been submitted
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C17648 (NCI Thesaurus ObjectClass-2)
C0439064 (UMLS 2011AA ObjectClass-2)
Item Group
Ae Module
Item
Common Toxicity Criteria Adverse Event Term Type
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CL.4
Code List
Common Toxicity Criteria Adverse Event Term Type
CL Item
Dyspnoea Nos (Dyspnea (shortness of breath))
CL Item
Fatigue (Fatigue (asthenia, lethargy, malaise))
C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)
CL Item
Menopausal Symptoms (Hot flashes/flushes)
CL Item
Mood Alteration - Agitation (Mood alteration - agitation)
CL Item
Anxiety Nec (Mood alteration - anxiety)
CL Item
Depression Nec (Mood alteration - depression)
CL Item
Euphoric Mood (Mood alteration - euphoria)
C27011 (NCI Thesaurus)
C0235146 (UMLS 2011AA)
CL Item
Muscle Weakness Nos (Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized)
C0151786 (NCI Metathesaurus)
CL Item
Nausea (Nausea)
C3258 (NCI Thesaurus)
C0027497 (UMLS 2011AA)
CL Item
Pain (Pain - Back)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
C3303 (NCI Thesaurus-3)
C0030193 (UMLS 2011AA-4)
C3303 (NCI Thesaurus-5)
C0030193 (UMLS 2011AA-6)
C3303 (NCI Thesaurus-7)
C0030193 (UMLS 2011AA-8)
C3303 (NCI Thesaurus-9)
C0030193 (UMLS 2011AA-10)
C3303 (NCI Thesaurus-11)
C0030193 (UMLS 2011AA-12)
C3303 (NCI Thesaurus-13)
C0030193 (UMLS 2011AA-14)
C3303 (NCI Thesaurus-15)
C0030193 (UMLS 2011AA-16)
C3303 (NCI Thesaurus-17)
C0030193 (UMLS 2011AA-18)
C3303 (NCI Thesaurus-19)
C0030193 (UMLS 2011AA-20)
C3303 (NCI Thesaurus-21)
C0030193 (UMLS 2011AA-22)
C3303 (NCI Thesaurus-23)
C0030193 (UMLS 2011AA-24)
C3303 (NCI Thesaurus-25)
C0030193 (UMLS 2011AA-26)
C3303 (NCI Thesaurus-27)
C0030193 (UMLS 2011AA-28)
C3303 (NCI Thesaurus-29)
C0030193 (UMLS 2011AA-30)
C3303 (NCI Thesaurus-31)
C0030193 (UMLS 2011AA-32)
C3303 (NCI Thesaurus-33)
C0030193 (UMLS 2011AA-34)
C3303 (NCI Thesaurus-35)
C0030193 (UMLS 2011AA-36)
C3303 (NCI Thesaurus-37)
C0030193 (UMLS 2011AA-38)
C3303 (NCI Thesaurus-39)
C0030193 (UMLS 2011AA-40)
C3303 (NCI Thesaurus-41)
C0030193 (UMLS 2011AA-42)
C3303 (NCI Thesaurus-43)
C0030193 (UMLS 2011AA-44)
C3303 (NCI Thesaurus-45)
C0030193 (UMLS 2011AA-46)
C3303 (NCI Thesaurus-47)
C0030193 (UMLS 2011AA-48)
C3303 (NCI Thesaurus-49)
C0030193 (UMLS 2011AA-50)
C3303 (NCI Thesaurus-51)
C0030193 (UMLS 2011AA-52)
C3303 (NCI Thesaurus-53)
C0030193 (UMLS 2011AA-54)
C3303 (NCI Thesaurus-55)
C0030193 (UMLS 2011AA-56)
C3303 (NCI Thesaurus-57)
C0030193 (UMLS 2011AA-58)
C3303 (NCI Thesaurus-59)
C0030193 (UMLS 2011AA-60)
C3303 (NCI Thesaurus-61)
C0030193 (UMLS 2011AA-62)
C3303 (NCI Thesaurus-63)
C0030193 (UMLS 2011AA-64)
C3303 (NCI Thesaurus-65)
C0030193 (UMLS 2011AA-66)
C3303 (NCI Thesaurus-67)
C0030193 (UMLS 2011AA-68)
C3303 (NCI Thesaurus-69)
C0030193 (UMLS 2011AA-70)
C3303 (NCI Thesaurus-71)
C0030193 (UMLS 2011AA-72)
C3303 (NCI Thesaurus-73)
C0030193 (UMLS 2011AA-74)
C3303 (NCI Thesaurus-75)
C0030193 (UMLS 2011AA-76)
CL Item
Headache Nos (Pain - Head/headache)
CL Item
Arthralgia (Pain - Joint)
C0003862 (NCI Metathesaurus)
CL Item
Myalgia (Pain - Muscle)
C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)
CL Item
Vomiting Nos (Vomiting)
AdverseEventNoAssessmentText
Item
Not Assessed
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C25217 (NCI Thesaurus Property-2)
C1516048 (UMLS 2011AA Property-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade (1-5)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
AdverseEventAbsentText
Item
Not present
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48190 (NCI Thesaurus Property)
C0332197 (UMLS 2011AA Property)
Item
CTC AE Attribution Code (see above)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.8
Code List
CTC AE Attribution Code (see above)
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)
Item Group
Header
AdverseEventNegativeAssessmentText
Item
Check box if no additional adverse events were experienced by patient
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C38757 (NCI Thesaurus Property-2)
C1513916 (UMLS 2011AA Property-2)
Item Group
Other Ae Module
CTC Adverse Event Term
Item
CTC Adverse Event Term Specify
text
C25685 (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 (1-5)
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC AE Attribution Code (see above)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.8
Code List
CTC AE Attribution Code (see above)
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)
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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