ID

6057

Beschrijving

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

Trefwoorden

  1. 26-08-12 26-08-12 -
  2. 26-11-14 26-11-14 - Martin Dugas
  3. 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
  4. 13-04-21 13-04-21 - Ahmed Rafee, MD
Geüploaded op

26 november 2014

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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

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

Header module
Beschrijving

Header module

Alias
UMLS CUI-1
C1320722
Visit number
Beschrijving

HospitalAdmissionOrdinalNumber

Datatype

text

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

Type III Adverse Events

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

ProtocolSpecifiedAdverseEventOccurrenceInd-2

Datatype

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?
Beschrijving

RadiationTherapyInterruptionInd-2

Datatype

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
Beschrijving

TreatmentInterruptionDayDuration

Datatype

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
Beschrijving

CetuximabCisplatinFluorouracilChemotherapyRegimenInterruptedToxicityInd-2

Datatype

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
Beschrijving

RadiationTherapyRegimenInterruptedToxicityInd-2

Datatype

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
Beschrijving

Comments

Comments
Beschrijving

ResearchCommentsText

Datatype

text

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

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

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI-1)

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