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  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0227 ADVERSE EVENT FORM
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Name
Type
Description | Question | Decode (Coded Value)
Data type
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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