Instructions: Complete at the end of weeks 12, 27, 54, 81. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in a Comments section. Place an X in appropriate boxes. Circle AMENDED items

Unnamed1
Description

Unnamed1

SWOG Patient ID
Description

SWOGPatientID

Data type

text

SWOG Study No.
Description

SWOGStudyNo.

Data type

text

Registration Step
Description

RegistrationStep

Data type

text

Patient Initials (L, F M)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Reporting interval number
Description

Reportingintervalnumber

Data type

text

If reporting interval #1, then Indicate week number for this submission
Description

Ifreportinginterval#1,thenIndicateweeknumberforthissubmission

Data type

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

Physician
Description

TreatingPhysician

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass
C25705
UMLS 2011AA ObjectClass
C1522326
Group Name
Description

ParticipatingGroupName

Data type

text

Study No.
Description

StudyNo.

Data type

text

Pt. ID
Description

Pt.ID

Data type

text

Disease Status
Description

Disease Status

Date of Last Contact or Death
Description

DeathDate/LastContactDate

Data type

date

Vital Status
Description

Patient'sVitalStatus

Data type

text

Reporting interval start date
Description

IntervalReportFromDate

Data type

date

Reporting interval end date
Description

IntervalReportToDate

Data type

date

Adverse Events
Description

Adverse Events

Were adverse events assessed during this time period?
Description

Weretoxicitiesassessedforthisreportinginterval?

Data type

text

Date of most recent toxicity assessment
Description

SymptomAssessmentDate

Data type

date

Unnamed3
Description

Unnamed3

Data type

text

Code
Description

CTCCode

Data type

text

Adverse Event
Description

CTCAdverseEventTerm

Data type

text

CTC 2.0 Grade (0-5)
Description

CTCAdverseEventGrade

Data type

text

Other Toxicities (specify)
Description

CTCAdverseEventTerm,Other

Data type

text

Comments
Description

Comments

Comments
Description

Comments

Data type

text

Ccrr Module For S0201 Observation Arm Assessment Form
Description

Ccrr Module For S0201 Observation Arm Assessment Form

Similar models

Instructions: Complete at the end of weeks 12, 27, 54, 81. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in a Comments section. Place an X in appropriate boxes. Circle AMENDED items

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
SWOGPatientID
Item
SWOG Patient ID
text
SWOGStudyNo.
Item
SWOG Study No.
text
RegistrationStep
Item
Registration Step
text
PatientInitialsName
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
Reportingintervalnumber
Item
Reporting interval number
text
Item
If reporting interval #1, then Indicate week number for this submission
text
Code List
If reporting interval #1, then Indicate week number for this submission
CL Item
Week 12 (Week 12)
CL Item
Week 27 (week 27)
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
TreatingPhysician
Item
Physician
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass)
C1522326 (UMLS 2011AA ObjectClass)
ParticipatingGroupName
Item
Group Name
text
StudyNo.
Item
Study No.
text
Pt.ID
Item
Pt. ID
text
Item Group
Disease Status
DeathDate/LastContactDate
Item
Date of Last Contact or Death
date
Item
Vital Status
text
Code List
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
IntervalReportFromDate
Item
Reporting interval start date
date
IntervalReportToDate
Item
Reporting interval end date
date
Item Group
Adverse Events
Item
Were adverse events assessed during this time period?
text
Code List
Were adverse events 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)
SymptomAssessmentDate
Item
Date of most recent toxicity assessment
date
Item
Unnamed3
text
Code List
Unnamed3
CL Item
Mark Box If Toxicities Were Assessed But None Were Seen. (Mark box if toxicities were assessed but none were seen.)
CTCCode
Item
Code
text
CTCAdverseEventTerm
Item
Adverse Event
text
Item
CTC 2.0 Grade (0-5)
text
Code List
CTC 2.0 Grade (0-5)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CTCAdverseEventTerm,Other
Item
Other Toxicities (specify)
text
Item Group
Comments
Comments
Item
Comments
text
Item Group
Ccrr Module For S0201 Observation Arm Assessment Form