ID

6661

Beschreibung

CALGB 40503 Supplemental Adverse Event (AE) Form Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=604DB84A-54BF-38D2-E040-BB89AD43495E

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=604DB84A-54BF-38D2-E040-BB89AD43495E

Stichworte

  1. 26.08.12 26.08.12 -
  2. 08.01.15 08.01.15 - Martin Dugas
Hochgeladen am

8. Januar 2015

DOI

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Breast Cancer NCT00601900 Toxicity - CALGB 40503 Supplemental Adverse Event (AE) Form - 2823361v1.0

If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records.

Header
Beschreibung

Header

CALGB Form
Beschreibung

Form ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No
Beschreibung

Protocol ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Beschreibung

Trial subject ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Reporting Period Start Date (MM DD YYYY)
Beschreibung

Reporting Period Start Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (MM DD YYYY)
Beschreibung

Reporting Period End Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Are data amended
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unnamed2
Beschreibung

Unnamed2

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 Hospital No.
Beschreibung

Medical Record Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Beschreibung

Institution Name

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group (Country name for International sites)
Beschreibung

Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Beschreibung

Study Number Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beschreibung

Trial subject ID Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Expected Adverse Events
Beschreibung

Expected Adverse Events

MedDRA Code
Beschreibung

MedDRACode

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
MedDRA Code
Beschreibung

MedDRACode

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC adverse event term
Beschreibung

CommonToxicityCriteriaAdverseEventTermType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC adverse event term
Beschreibung

CommonToxicityCriteriaAdverseEventTermType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC AE grade (^1)
Beschreibung

CommonToxicityCriteriaAdverseEventGrade

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC AE grade (^1)
Beschreibung

CommonToxicityCriteriaAdverseEventGrade

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Duration (in days of highest grade during assessment period)
Beschreibung

AdverseEventWorstSymptomDayDuration

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Thesaurus Property-2
C25719
UMLS 2011AA Property-2
C1522166
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
Duration (in days of highest grade during assessment period)
Beschreibung

AdverseEventWorstSymptomDayDuration

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
NCI Thesaurus Property-2
C25719
UMLS 2011AA Property-2
C1522166
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
Attributable to which medication (Mark all that apply)
Beschreibung

AgentAdverseEventAttributionName

Datentyp

text

Alias
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property-2
C25358
UMLS 2011AA Property-2
C0596130
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Attributable to which medication (Mark all that apply)
Beschreibung

AgentAdverseEventAttributionName

Datentyp

text

Alias
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property-2
C25358
UMLS 2011AA Property-2
C0596130
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Completed by (Last name, First name)
Beschreibung

Person Completing Form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date form completed (MM DD YYYY)
Beschreibung

Date Form Completed

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367

Ähnliche Modelle

If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records.

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period Start Date
Item
Reporting Period Start Date (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Unnamed2
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group (Country name for International sites)
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Expected Adverse Events
MedDRACode
Item
MedDRA Code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
MedDRACode
Item
MedDRA Code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
CommonToxicityCriteriaAdverseEventTermType
Item
CTC adverse event term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventTermType
Item
CTC adverse event term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC AE grade (^1)
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC AE grade (^1)
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
AdverseEventWorstSymptomDayDuration
Item
Duration (in days of highest grade during assessment period)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
AdverseEventWorstSymptomDayDuration
Item
Duration (in days of highest grade during assessment period)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
Item
Attributable to which medication (Mark all that apply)
text
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property-2)
C0596130 (UMLS 2011AA Property-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Attributable to which medication (Mark all that apply)
CL Item
Tamoxifen Letrozole (Letrozole/Tamoxifen)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
C855 (NCI Thesaurus-3)
C0039286 (UMLS 2011AA-4)
CL Item
Placebo Bevacizumab (Bevacizumab/Placebo)
C753 (NCI Thesaurus)
C0032042 (UMLS 2011AA)
C2039 (NCI Thesaurus-3)
C0796392 (UMLS 2011AA-4)
Item
Attributable to which medication (Mark all that apply)
text
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property-2)
C0596130 (UMLS 2011AA Property-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Attributable to which medication (Mark all that apply)
CL Item
Tamoxifen Letrozole (Letrozole/Tamoxifen)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
C855 (NCI Thesaurus-3)
C0039286 (UMLS 2011AA-4)
CL Item
Placebo Bevacizumab (Bevacizumab/Placebo)
C753 (NCI Thesaurus)
C0032042 (UMLS 2011AA)
C2039 (NCI Thesaurus-3)
C0796392 (UMLS 2011AA-4)
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date form completed (MM DD YYYY)
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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