Kidney Cancer NCT01120249 Toxicity - Southwest Oncology Group S0931 Adverse Event Form (Form #552) - 2998452v1.0 - Portal de Modelos de Datos Médicos (MDM-Portal)

ID

8401

Descripción

Southwest Oncology Group S0931 Adverse Event Form (Form #552) Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E26385C-8BFB-C34F-E040-BB89AD434A8D

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7E26385C-8BFB-C34F-E040-BB89AD434A8D

Palabras clave

Klinische Studie [Dokumenttyp]

Adverse event

D018675

Kidney Neoplasms

19/9/12 19/9/12 -
8/1/15 8/1/15 - Martin Dugas
9/1/15 9/1/15 - Martin Dugas

Subido en

9 de enero de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy

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Instructions: Please complete this form after each cycle (1 cycle = 42 calendar days, regardless of dose delays). Report adverse events occurring up until the next cycle of treatment begins. Document the worst Grade seen during the reporting period. Do not code a condition existing prior to registration as an adverse event unless it worsens. Category lists may not include all adverse events from that category. Record any observed adverse events not listed on the blank lines at the end. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

1 formularios

StudyEvent: Southwest Oncology Group S0931 Adverse Event Form (Form #552)
1. Instructions: Please complete this form after each cycle (1 cycle = 42 calendar days, regardless of dose delays). Report adverse events occurring up until the next cycle of treatment begins. Document the worst Grade seen during the reporting period. Do not code a condition existing prior to registration as an adverse event unless it worsens. Category lists may not include all adverse events from that category. Record any observed adverse events not listed on the blank lines at the end. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

Header

Descripción

Header

SWOG Patient ID

Descripción

Trial subject ID SWOG

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS CUI-1: C2348585

NCI Thesaurus ObjectClass: C16960

UMLS CUI-2: C1519429

NCI Thesaurus Property: C25364

NCI Thesaurus Property-2: C25699

SWOG Study No.

Descripción

Protocol ID SWOG

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS CUI-1: C3274381

NCI Thesaurus ObjectClass: C25320

UMLS CUI-2: C1519429

NCI Thesaurus Property: C25364

NCI Thesaurus Property-2: C25699

Registration Step

Descripción

Registration Number

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS CUI-1: C1514821

NCI Thesaurus ObjectClass: C25646

UMLS CUI-2: C0237753

NCI Thesaurus Property: C16154

NCI Thesaurus ValueDomain-2: C16154

Patient Initials (L, F M)

Descripción

Patient Initials

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25191

UMLS CUI-1: C2986440

NCI Thesaurus ObjectClass: C16960

NCI Thesaurus Property: C25536

Current Cycle Number

Descripción

Cycle Number Chemotherapeutics

Tipo de datos

integer

Alias

NCI Thesaurus ValueDomain: C25337

UMLS CUI-1: C2045829

NCI Thesaurus Property: C25471

NCI Thesaurus ObjectClass: C15368

NCI Thesaurus Property-2: C25379

Institution/Affiliate

Descripción

Institution Name

Tipo de datos

text

Alias

NCI Thesaurus ObjectClass: C25454

UMLS CUI-1: C1301943

NCI Thesaurus ObjectClass-2: C21541

NCI Thesaurus Property: C25364

NCI Thesaurus ValueDomain: C25191

NCI Thesaurus ValueDomain-2: C21541

Physician

Descripción

Investigator Name

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25191

UMLS CUI-1: C2826892

NCI Thesaurus Property: C25364

NCI Thesaurus ObjectClass: C17089

NCI Thesaurus ObjectClass-2: C25644

Participating Group Name

Descripción

Participating Group

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25191

UMLS CUI-1: C2347449

NCI Thesaurus ObjectClass: C25608

NCI Thesaurus ObjectClass-2: C17005

NCI Thesaurus Property: C25364

Participating Group Study No.

Descripción

Study Number Participating Group

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS CUI-1: C3274381

NCI Thesaurus ObjectClass: C25320

UMLS CUI-2: C2347449

NCI Thesaurus Property: C25608

NCI Thesaurus Property-2: C25364

Participating Group Patient ID

Descripción

Trial subject ID Participating Group

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS CUI-1: C2348585

NCI Thesaurus ObjectClass: C16960

UMLS CUI-2: C2347449

NCI Thesaurus Property: C25608

NCI Thesaurus Property-2: C25364

Comments

Descripción

Comments

Descripción

Research Comments

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25704

UMLS CUI-1: C0947611

NCI Thesaurus ObjectClass: C15319

NCI Thesaurus Property: C25393

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Instructions: Please complete this form after each cycle (1 cycle = 42 calendar days, regardless of dose delays). Report adverse events occurring up until the next cycle of treatment begins. Document the worst Grade seen during the reporting period. Do not code a condition existing prior to registration as an adverse event unless it worsens. Category lists may not include all adverse events from that category. Record any observed adverse events not listed on the blank lines at the end. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

1 formularios

StudyEvent: Southwest Oncology Group S0931 Adverse Event Form (Form #552)
1. Instructions: Please complete this form after each cycle (1 cycle = 42 calendar days, regardless of dose delays). Report adverse events occurring up until the next cycle of treatment begins. Document the worst Grade seen during the reporting period. Do not code a condition existing prior to registration as an adverse event unless it worsens. Category lists may not include all adverse events from that category. Record any observed adverse events not listed on the blank lines at the end. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Header Module

Item Group

Header

Trial subject ID SWOG

Item

SWOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)

Protocol ID SWOG

Item

SWOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)

Registration Number

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)

Patient Initials

Item

Patient Initials (L, F M)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Cycle Number Chemotherapeutics

Item

Current Cycle Number

integer

C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Investigator Name

Item

Physician

text

C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)

Participating Group

Item

Participating Group Name

text

C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Adverse Events

Item Group

Adverse Events

Reporting Period Start Date

Item

Reporting Period Start Date (MM DD YYYY Day 1 of this Cycle)

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Item

CTC Adverse Event Term (Other)

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)

Reporting Period End Date

Item

Reporting Period End Date (MM DD YYYY Day one of next cycle. If final cycle, date of first visit or contact after resolution of acute adverse events.)

date

C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)

AdverseEventSeverityGrade

Item

CTC AE Grade

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)

CL.6

Code List

CTC AE Grade

CL Item

Mild Adverse Event (1)

C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)

CL Item

Life Threatening Adverse Event (4)

C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

AdverseEventCurrentAssessmentInd

Item

Were adverse events assessed during this time period?

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)

CL.1

Code List

Were adverse events assessed during this time period?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)

CL Item

Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)

CTC Adverse Event Attribution Category

Item

CTC Adverse Event Attribution Code

text

C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)

CL.7

Code List

CTC Adverse Event Attribution Code

CL Item

Definite (Definite)

CL209464 (NCI Metathesaurus)

CL Item

Possible (Possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (Probable)

C0332148 (NCI Metathesaurus)

CL Item

Unlikely (Unlikely)

CL Item

Unrelated (Unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

AdverseEventCourseAssessmentStatus

Item

Adverse event status code

text

C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25379 (NCI Thesaurus Property-2)
C0750729 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.8

Code List

Adverse event status code

CL Item

Continues At Same Or Lower Grade (Continues at same or lower grade)

CL Item

Increased Grade Or Improved Then Worsened (Increased grade or improved then worsened)

CL Item

New (New)

C25586 (NCI Thesaurus)
C0205314 (UMLS 2011AA)

CTC Adverse Event Term, Other

Item Group

Ctc Adverse Event Term, Other

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Item

CTC Adverse Event Term (Other)

text

AdverseEventSeverityGrade

Item

CTC AE Grade

text

CL.6

Code List

CTC AE Grade

CL Item

Mild Adverse Event (1)

C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)

CL Item

Life Threatening Adverse Event (4)

C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

CTC Adverse Event Attribution Category

Item

CTC Adverse Event Attribution Code

text

C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)

CL.7

Code List

CTC Adverse Event Attribution Code

CL Item

Definite (Definite)

CL209464 (NCI Metathesaurus)

CL Item

Possible (Possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (Probable)

C0332148 (NCI Metathesaurus)

CL Item

Unlikely (Unlikely)

CL Item

Unrelated (Unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

AdverseEventCourseAssessmentStatus

Item

Adverse event status code

text

CL.8

Code List

Adverse event status code

CL Item

Continues At Same Or Lower Grade (Continues at same or lower grade)

CL Item

Increased Grade Or Improved Then Worsened (Increased grade or improved then worsened)

CL Item

New (New)

C25586 (NCI Thesaurus)
C0205314 (UMLS 2011AA)

Comments

Item Group

Comments

Research Comments

Item

Comments

text

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

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Versiones (3)

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Kidney Cancer NCT01120249 Toxicity - Southwest Oncology Group S0931 Adverse Event Form (Form #552) - 2998452v1.0

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