ID

11362

Descrizione

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

collegamento

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

Keywords

versioni (3)
  1. 27/08/12 27/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 03/07/15 03/07/15 -
Caricato su

3 luglio 2015

DOI

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Licenza

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

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0227 ADVERSE EVENT FORM
    1. No Instruction available.
Header
Descrizione

Header

SWOG Patient ID
Descrizione

SWOGPatientID

Tipo di dati

text

SWOG Study No.
Descrizione

SWOGStudyNo.

Tipo di dati

text

Registration Step
Descrizione

RegistrationStep

Tipo di dati

text

Cycle Number
Descrizione

CycleNumber

Tipo di dati

text

Patient Initials (L, F M)
Descrizione

Patient Initials

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution / Affiliate
Descrizione

InstitutionName

Tipo di dati

text

Physician (Groups Other than SWOG)
Descrizione

RegisteredInvestigator

Tipo di dati

text

Group Name
Descrizione

ParticipatingGroupName

Tipo di dati

text

Study No.
Descrizione

Particip.GroupProtocolNumber

Tipo di dati

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.)
Descrizione

PatientStudyID,ParticipatingGroup

Tipo di dati

text

Toxicity
Descrizione

Toxicity

Reporting period start date
Descrizione

IntervalReportFromDate

Tipo di dati

date

Reporting period end date
Descrizione

IntervalReportToDate

Tipo di dati

date

Were toxicities assessed during this time period
Descrizione

Weretoxicitiesassessedforthisreportinginterval?

Tipo di dati

text

Date of most recent toxicity assessment
Descrizione

SymptomAssessmentDate

Tipo di dati

date

Adverse event assessment
Descrizione

Adverse event assessment

CTC Adverse Event Term
Descrizione

CTCAdverseEventTerm

Tipo di dati

text

CTC Adverse Event Grade (1 - 5)
Descrizione

CTCAdverseEventGrade

Tipo di dati

text

CTC Adverse Event Attribution Code (Attribution codes)
Descrizione

CTCAdverseEventAttributionCode

Tipo di dati

text

Adverse Event Status Code (Status codes)
Descrizione

LateAdverseEventStatus

Tipo di dati

text

CTC Adverse Event Term, Other
Descrizione

CTCAdverseEventTerm,Other

Tipo di dati

text

Comments
Descrizione

Comments

Comments
Descrizione

Comments

Tipo di dati

text

Ccrr Module For Southwest Oncology Group S0227 Adverse Event Form
Descrizione

Ccrr Module For Southwest Oncology Group S0227 Adverse Event Form

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Similar models

No Instruction available.

1 moduli
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0227 ADVERSE EVENT FORM
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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