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ID
42230
Descripción
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
Palabras clave
Versiones (4)
- 26/8/12 26/8/12 -
- 26/11/14 26/11/14 - Martin Dugas
- 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
- 13/4/21 13/4/21 - Ahmed Rafee, MD
Titular de derechos de autor
foglt
Subido en
13 de abril de 2021
DOI
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Licencia
Creative Commons BY 4.0
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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
- StudyEvent: AMC-045 Type III Adverse Event Reporting Form (TAE)
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
- StudyEvent: AMC-045 Type III Adverse Event Reporting Form (TAE)
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Visit number
Item
Visit number
text
C25337 (NCI Thesaurus ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
C1549755 (UMLS CUI-1)
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)
(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)
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)
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)
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)
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)
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)
Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI-1)