ID

2525

Description

S0201 Melacine Arm Cycle-Specific Toxicity and Dosage Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A93417EC-7384-694A-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A93417EC-7384-694A-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Melanoma (Skin) null Toxicity - S0201 Melacine Arm Cycle-Specific Toxicity and Dosage Form - 2055710v3.0

English

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

1 forms  
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
Cycle Number
Description

CurrentCourseNumber

Data type

double

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

Ifcycle#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

Treatment Status
Description

Treatment Status

Is patient still on protocol treatment?
Description

Ispatientstillonprotocoltreatment?

Data type

text

Were there any additions, adjustments or omissions to protocol treatment?
Description

DoseModification(Change)

Data type

text

If yes, specify amount and reason
Description

DoseModificationReason

Data type

text

Number of Melacine injections
Description

NumberofMelacineinjections

Data type

text

First date of treatment during this cycle
Description

TreatmentFirstDoseBeginDate

Data type

date

Last date of treatment during this cycle
Description

TreatmentLastDoseEndDate

Data type

date

Toxicity
Description

Toxicity

Were toxicities assessed during this time period?
Description

Weretoxicitiesassessedduringthistimeperiod?

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

Toxicity
Description

CTCAdverseEventTerm

Data type

text

CTC 2.0 Grade (0-5)
Description

CTCAdverseEventGrade

Data type

text

Treatment Relation
Description

CTCAdverseEventAttributionCode

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 Melacine Arm Cycle-specific Toxicity And Dosage Form
Description

Ccrr Module For S0201 Melacine Arm Cycle-specific Toxicity And Dosage Form

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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

1 forms
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)
CurrentCourseNumber
Item
Cycle Number
double
Item
If cycle #1, then Indicate week number for this submission
text
CL.1
Code List
If cycle #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
CL.2
Code List
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item Group
Treatment Status
Item
Is patient still on protocol treatment?
text
CL.3
Code List
Is patient still on protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Were there any additions, adjustments or omissions to protocol treatment?
text
CL.4
Code List
Were there any additions, adjustments or omissions to protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned (per protocol guidelines))
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned (not per protocol guidelines))
DoseModificationReason
Item
If yes, specify amount and reason
text
NumberofMelacineinjections
Item
Number of Melacine injections
text
TreatmentFirstDoseBeginDate
Item
First date of treatment during this cycle
date
TreatmentLastDoseEndDate
Item
Last date of treatment during this cycle
date
Item Group
Toxicity
Item
Were toxicities assessed during this time period?
text
CL.5
Code List
Were toxicities assessed during this time period?
CL Item
No2005340 (No)
CL Item
Yes2005341 (Yes)
SymptomAssessmentDate
Item
Date of most recent toxicity assessment
date
Item
Unnamed3
text
CL.6
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
Toxicity
text
Item
CTC 2.0 Grade (0-5)
text
CL.7
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)
Item
Treatment Relation
text
CL.8
Code List
Treatment Relation
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)
CTCAdverseEventTerm,Other
Item
Other Toxicities (specify)
text
Item Group
Comments
Comments
Item
Comments
text
Item Group
Ccrr Module For S0201 Melacine Arm Cycle-specific Toxicity And Dosage Form
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