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ID
11362
Beschrijving
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
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Versies (3)
- 27-08-12 27-08-12 -
- 09-01-15 09-01-15 - Martin Dugas
- 03-07-15 03-07-15 -
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3 juli 2015
DOI
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Creative Commons BY-NC 3.0 Legacy
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NCT00057928 SOUTHWEST ONCOLOGY GROUP S0227 ADVERSE EVENT FORM
No Instruction available.
- StudyEvent: SOUTHWEST ONCOLOGY GROUP S0227 ADVERSE EVENT FORM
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- StudyEvent: SOUTHWEST ONCOLOGY GROUP S0227 ADVERSE EVENT FORM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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)
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
IntervalReportFromDate
Item
Reporting period start date
date
IntervalReportToDate
Item
Reporting period end date
date
Item
Were toxicities assessed during this time period
text
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCAdverseEventGrade
Item
CTC Adverse Event Grade (1 - 5)
text
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possibly (possible)
CL Item
Probably (probable)
CL Item
Definitely (definite)
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
Comments
Item
Comments
text