Details Anal Cancer NCT00324415 Toxicity - AMC-045 Type III Adverse Event Reporting Form (TAE) - 2516535v1.0 - Portal für Medizinische Datenmodelle (MDM-Portal)

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 Formulare

StudyEvent: AMC-045 Type III Adverse Event Reporting Form (TAE)
1. 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

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Administrative

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)

Severe Adverse Event (Grade 3)

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)

Comments

Item Group

Comments

Item

Comments

text

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

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