ID

506

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

Versies (4)
  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 augustus 2012

DOI

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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

Engels

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 Formulieren  
Unnamed1
Beschrijving

Unnamed1

Visit number
Beschrijving

HospitalAdmissionOrdinalNumber

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16696
UMLS 2011AA ObjectClass
C0019994
NCI Thesaurus Property
C25385
UMLS 2011AA Property
C0809949
Type Iii Adverse Events
Beschrijving

Type Iii Adverse Events

Has the patient experienced a Type III adverse event
Beschrijving

ProtocolSpecifiedAdverseEventOccurrenceInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C38024
UMLS 2011AA ObjectClass
C0205369
NCI Metathesaurus Property
CL209504
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was RT interrupted for more than one week?
Beschrijving

RadiationTherapyInterruptionInd-2

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
Days Treatment Was Interrupted
Beschrijving

TreatmentInterruptionDayDuration

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25330
UMLS 2011AA ValueDomain
C0449238
NCI Thesaurus Property
C25542
UMLS 2011AA Property
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

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C376
UMLS 2011AA ObjectClass
C0008838
NCI Thesaurus ObjectClass
C1723
UMLS 2011AA ObjectClass
C0879636
NCI Thesaurus ObjectClass
C505
UMLS 2011AA ObjectClass
C0016360
NCI Thesaurus Property
C27990
UMLS 2011AA Property
C0600688
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Metathesaurus Property
CL212531
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the subject failed to complete the prescribed course of irradiation due to toxicity
Beschrijving

RadiationTherapyRegimenInterruptedToxicityInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C27990
UMLS 2011AA Property
C0600688
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Metathesaurus Property
CL212531
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Comments
Beschrijving

Comments

Comments
Beschrijving

ResearchCommentsText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed1
HospitalAdmissionOrdinalNumber
Item
Visit number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25385 (NCI Thesaurus Property)
C0809949 (UMLS 2011AA Property)
Item Group
Type Iii Adverse Events
Item
Has the patient experienced a Type III adverse event
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C38024 (NCI Thesaurus ObjectClass)
C0205369 (UMLS 2011AA ObjectClass)
CL209504 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.1
Code List
Has the patient experienced a Type III adverse event
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was RT interrupted for more than one week?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
CL.2
Code List
Was RT interrupted for more than one week?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
TreatmentInterruptionDayDuration
Item
Days Treatment Was Interrupted
double
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
Item
Has the subject failed to receive 6 courses of cetuximab and 2 cycles of cisplatin and 5-FU due to toxicity
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C376 (NCI Thesaurus ObjectClass)
C0008838 (UMLS 2011AA ObjectClass)
C1723 (NCI Thesaurus ObjectClass)
C0879636 (UMLS 2011AA ObjectClass)
C505 (NCI Thesaurus ObjectClass)
C0016360 (UMLS 2011AA ObjectClass)
C27990 (NCI Thesaurus Property)
C0600688 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
CL212531 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.3
Code List
Has the subject failed to receive 6 courses of cetuximab and 2 cycles of cisplatin and 5-FU due to toxicity
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Has the subject failed to complete the prescribed course of irradiation due to toxicity
text
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C27990 (NCI Thesaurus Property)
C0600688 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
CL212531 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.4
Code List
Has the subject failed to complete the prescribed course of irradiation due to toxicity
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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