ID

11362

Descripción

NCT00057928 SOUTHWEST ONCOLOGY GROUP S0227 ADVERSE EVENT FORM S0227 Comparison of Cisplatin Combined With Either Paclitaxel or Gemcitabine in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A9C36E5D-1E71-3661-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A9C36E5D-1E71-3661-E034-0003BA12F5E7

Palabras clave

Versiones (3)
  1. 27/8/12 27/8/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 3/7/15 3/7/15 -
Subido en

3 de julio de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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NCT00057928 SOUTHWEST ONCOLOGY GROUP S0227 ADVERSE EVENT FORM

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0227 ADVERSE EVENT FORM
    1. No Instruction available.
Header
Descripción

Header

SWOG Patient ID
Descripción

SWOGPatientID

Tipo de datos

text

SWOG Study No.
Descripción

SWOGStudyNo.

Tipo de datos

text

Registration Step
Descripción

RegistrationStep

Tipo de datos

text

Cycle Number
Descripción

CycleNumber

Tipo de datos

text

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
Institution / Affiliate
Descripción

InstitutionName

Tipo de datos

text

Physician (Groups Other than SWOG)
Descripción

RegisteredInvestigator

Tipo de datos

text

Group Name
Descripción

ParticipatingGroupName

Tipo de datos

text

Study No.
Descripción

Particip.GroupProtocolNumber

Tipo de datos

float

Pt. ID (Instructions: Please complete this form after each cycle one cycle = 3 weeks. Report adverse events occuring up until the next cycle of treatment begins. Document the worst Grade seen during the reporting interval. Do not code a pre-existing condition as an adverse event unless it worsens due to treatment. 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.)
Descripción

PatientStudyID,ParticipatingGroup

Tipo de datos

text

Toxicity
Descripción

Toxicity

Reporting period start date
Descripción

IntervalReportFromDate

Tipo de datos

date

Reporting period end date
Descripción

IntervalReportToDate

Tipo de datos

date

Were toxicities assessed during this time period
Descripción

Weretoxicitiesassessedforthisreportinginterval?

Tipo de datos

text

Date of most recent toxicity assessment
Descripción

SymptomAssessmentDate

Tipo de datos

date

Adverse event assessment
Descripción

Adverse event assessment

CTC Adverse Event Term
Descripción

CTCAdverseEventTerm

Tipo de datos

text

CTC Adverse Event Grade (1 - 5)
Descripción

CTCAdverseEventGrade

Tipo de datos

text

CTC Adverse Event Attribution Code (Attribution codes)
Descripción

CTCAdverseEventAttributionCode

Tipo de datos

text

Adverse Event Status Code (Status codes)
Descripción

LateAdverseEventStatus

Tipo de datos

text

CTC Adverse Event Term, Other
Descripción

CTCAdverseEventTerm,Other

Tipo de datos

text

Comments
Descripción

Comments

Comments
Descripción

Comments

Tipo de datos

text

Ccrr Module For Southwest Oncology Group S0227 Adverse Event Form
Descripción

Ccrr Module For Southwest Oncology Group S0227 Adverse Event Form

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Similar models

No Instruction available.

1 formularios
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0227 ADVERSE EVENT FORM
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
SWOGPatientID
Item
SWOG Patient ID
text
SWOGStudyNo.
Item
SWOG Study No.
text
RegistrationStep
Item
Registration Step
text
CycleNumber
Item
Cycle Number
text
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)
InstitutionName
Item
Institution / Affiliate
text
RegisteredInvestigator
Item
Physician (Groups Other than SWOG)
text
ParticipatingGroupName
Item
Group Name
text
Particip.GroupProtocolNumber
Item
Study No.
float
PatientStudyID,ParticipatingGroup
Item
Pt. ID (Instructions: Please complete this form after each cycle one cycle = 3 weeks. Report adverse events occuring up until the next cycle of treatment begins. Document the worst Grade seen during the reporting interval. Do not code a pre-existing condition as an adverse event unless it worsens due to treatment. 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.)
text
Item Group
Toxicity
IntervalReportFromDate
Item
Reporting period start date
date
IntervalReportToDate
Item
Reporting period end date
date
Item
Were toxicities assessed during this time period
text
CL.1
Code List
Were toxicities assessed during this time period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
toxicities were assessed but none were seen (toxicities were assessed but none were seen)
SymptomAssessmentDate
Item
Date of most recent toxicity assessment
date
Item Group
Adverse event assessment
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCAdverseEventGrade
Item
CTC Adverse Event Grade (1 - 5)
text
Item
CTC Adverse Event Attribution Code (Attribution codes)
text
CL.2
Code List
CTC Adverse Event Attribution Code (Attribution codes)
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possibly (possible)
CL Item
Probably (probable)
CL Item
Definitely (definite)
Item
Adverse Event Status Code (Status codes)
text
CL.3
Code List
Adverse Event Status Code (Status codes)
CL Item
New Late Adverse Event (new)
CL Item
persistent (persistent)
CL Item
resolved and recurred (resolved and recurred)
CTCAdverseEventTerm,Other
Item
CTC Adverse Event Term, Other
text
Item Group
Comments
Comments
Item
Comments
text
Item Group
Ccrr Module For Southwest Oncology Group S0227 Adverse Event Form
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