ID

42230

Description

AMC-045 Type III Adverse Event Reporting Form (TAE) Cisplatin, Fluorouracil, Cetuximab, and Radiation Therapy in Treating Patients With HIV and Stage I, Stage II, or Stage III Anal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1C146B28-823F-583B-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1C146B28-823F-583B-E044-0003BA3F9857

Keywords

Versions (4)
  1. 8/26/12 8/26/12 -
  2. 11/26/14 11/26/14 - Martin Dugas
  3. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  4. 4/13/21 4/13/21 - Ahmed Rafee, MD
Copyright Holder

foglt

Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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Anal Cancer NCT00324415 Toxicity - AMC-045 Type III Adverse Event Reporting Form (TAE) - 2516535v1.0

English

This form should be completed at week 18 for Type III Adverse Events. Type III Adverse Event - (1) any interruption in radiation therapy lasting more that 7 days, (2) failure to complete at least 6 courses of cetuximab and 2 cycles of cisplatin and 5-FU due to toxicity, (3) failure to complete the prescribed course of irradiation due to toxicity

1 forms  
Header module
Description

Header module

Alias
UMLS CUI-1
C1320722
Visit number
Description

HospitalAdmissionOrdinalNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus Property
C25385
UMLS CUI-1
C1549755
Type III Adverse Events
Description

Type III Adverse Events

Alias
UMLS CUI-1
C1519275
UMLS CUI-2
Has the patient experienced a Type III adverse event
Description

ProtocolSpecifiedAdverseEventOccurrenceInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus ObjectClass
C38024
NCI Metathesaurus Property
CL209504
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1507394
UMLS CUI-2
C0877248
UMLS CUI-3
C0205369
UMLS CUI-4
C1512698
Was RT interrupted for more than one week?
Description

RadiationTherapyInterruptionInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus Property
C25542
UMLS CUI-1
C1512698
UMLS CUI-2
C1522449
UMLS CUI-3
C1512900
Days Treatment Was Interrupted
Description

TreatmentInterruptionDayDuration

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25301
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25330
NCI Thesaurus Property
C25542
UMLS CUI-1
C0439228
UMLS CUI-2
C0449238
UMLS CUI-3
C1512900
Has the subject failed to receive 6 courses of cetuximab and 2 cycles of cisplatin and 5-FU due to toxicity
Description

CetuximabCisplatinFluorouracilChemotherapyRegimenInterruptedToxicityInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15632
NCI Thesaurus ObjectClass
C376
NCI Thesaurus ObjectClass
C1723
NCI Thesaurus ObjectClass
C505
NCI Thesaurus Property
C27990
NCI Thesaurus Property
C15697
NCI Metathesaurus Property
CL212531
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0392920
UMLS CUI-2
C0008838
UMLS CUI-3
C0879636
UMLS CUI-4
C0016360
UMLS CUI-5
C0600688
UMLS CUI-6
C0040808
UMLS CUI-7
C1512698
Has the subject failed to complete the prescribed course of irradiation due to toxicity
Description

RadiationTherapyRegimenInterruptedToxicityInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus Property
C27990
NCI Thesaurus Property
C15697
NCI Metathesaurus Property
CL212531
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1522449
UMLS CUI-2
C0600688
UMLS CUI-3
C0040808
UMLS CUI-4
C1512698
Comments
Description

Comments

Alias
UMLS CUI-1
C0947611
Comments
Description

ResearchCommentsText

Data type

text

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

This form should be completed at week 18 for Type III Adverse Events. Type III Adverse Event - (1) any interruption in radiation therapy lasting more that 7 days, (2) failure to complete at least 6 courses of cetuximab and 2 cycles of cisplatin and 5-FU due to toxicity, (3) failure to complete the prescribed course of irradiation due to toxicity

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header module
C1320722 (UMLS CUI-1)
Visit number
Item
Visit number
text
C25337 (NCI Thesaurus ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
C1549755 (UMLS CUI-1)
Item Group
Type III Adverse Events
C1519275 (UMLS CUI-1)
(UMLS CUI-2)
ProtocolSpecifiedAdverseEventOccurrenceInd-2
Item
Has the patient experienced a Type III adverse event
boolean
C25320 (NCI Thesaurus ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C38024 (NCI Thesaurus ObjectClass)
CL209504 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1507394 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0205369 (UMLS CUI-3)
C1512698 (UMLS CUI-4)
RadiationTherapyInterruptionInd-2
Item
Was RT interrupted for more than one week?
boolean
C38147 (NCI Thesaurus ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C25542 (NCI Thesaurus Property)
C1512698 (UMLS CUI-1)
C1522449 (UMLS CUI-2)
C1512900 (UMLS CUI-3)
TreatmentInterruptionDayDuration
Item
Days Treatment Was Interrupted
integer
C25301 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25330 (NCI Thesaurus ValueDomain)
C25542 (NCI Thesaurus Property)
C0439228 (UMLS CUI-1)
C0449238 (UMLS CUI-2)
C1512900 (UMLS CUI-3)
CetuximabCisplatinFluorouracilChemotherapyRegimenInterruptedToxicityInd-2
Item
Has the subject failed to receive 6 courses of cetuximab and 2 cycles of cisplatin and 5-FU due to toxicity
boolean
C15632 (NCI Thesaurus ObjectClass)
C376 (NCI Thesaurus ObjectClass)
C1723 (NCI Thesaurus ObjectClass)
C505 (NCI Thesaurus ObjectClass)
C27990 (NCI Thesaurus Property)
C15697 (NCI Thesaurus Property)
CL212531 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C0392920 (UMLS CUI-1)
C0008838 (UMLS CUI-2)
C0879636 (UMLS CUI-3)
C0016360 (UMLS CUI-4)
C0600688 (UMLS CUI-5)
C0040808 (UMLS CUI-6)
C1512698 (UMLS CUI-7)
RadiationTherapyRegimenInterruptedToxicityInd-2
Item
Has the subject failed to complete the prescribed course of irradiation due to toxicity
boolean
C15313 (NCI Thesaurus ObjectClass)
C27990 (NCI Thesaurus Property)
C15697 (NCI Thesaurus Property)
CL212531 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C0600688 (UMLS CUI-2)
C0040808 (UMLS CUI-3)
C1512698 (UMLS CUI-4)
Item Group
Comments
C0947611 (UMLS CUI-1)
Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI-1)
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