ID

9235

Beschrijving

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

Trefwoorden

Versies (2)
  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
Geüploaded op

9 januari 2015

DOI

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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

Engels

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 Formulieren  
Header
Beschrijving

Header

SWOG Patient ID
Beschrijving

SWOGPatientID

Datatype

text

SWOG Study No.
Beschrijving

SWOGStudyNo.

Datatype

text

Registration Step
Beschrijving

RegistrationStep

Datatype

text

Patient Initials (L, F M)
Beschrijving

Patient Initials

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Cycle Number
Beschrijving

Cycle Number Chemotherapeutics

Datatype

float

Alias
UMLS CUI-1
C2045829
If cycle #1, then Indicate week number for this submission
Beschrijving

Ifcycle#1,thenIndicateweeknumberforthissubmission

Datatype

text

Institution/Affiliate
Beschrijving

MainMemberInstitution/Affiliate

Datatype

text

Physician
Beschrijving

TreatingPhysician

Datatype

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
Group Name
Beschrijving

ParticipatingGroupName

Datatype

text

Study No.
Beschrijving

StudyNo.

Datatype

text

Pt. ID
Beschrijving

Pt.ID

Datatype

text

Disease Status
Beschrijving

Disease Status

Date of Last Contact or Death
Beschrijving

DeathDate/LastContactDate

Datatype

date

Vital Status
Beschrijving

Patient'sVitalStatus

Datatype

text

Treatment Status
Beschrijving

Treatment Status

Is patient still on protocol treatment?
Beschrijving

Ispatientstillonprotocoltreatment?

Datatype

boolean

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

DoseModification(Change)

Datatype

text

If yes, specify amount and reason
Beschrijving

DoseModificationReason

Datatype

text

Number of Melacine injections
Beschrijving

NumberofMelacineinjections

Datatype

text

First date of treatment during this cycle
Beschrijving

TreatmentFirstDoseBeginDate

Datatype

date

Last date of treatment during this cycle
Beschrijving

TreatmentLastDoseEndDate

Datatype

date

Toxicity
Beschrijving

Toxicity

Were toxicities assessed during this time period?
Beschrijving

Weretoxicitiesassessedduringthistimeperiod?

Datatype

boolean

Date of most recent toxicity assessment
Beschrijving

SymptomAssessmentDate

Datatype

date

Unnamed3
Beschrijving

Unnamed3

Datatype

text

Code
Beschrijving

CTCCode

Datatype

text

Toxicity
Beschrijving

CTCAdverseEventTerm

Datatype

text

CTC 2.0 Grade (0-5)
Beschrijving

CTCAdverseEventGrade

Datatype

text

Treatment Relation
Beschrijving

CTCAdverseEventAttributionCode

Datatype

text

Other Toxicities (specify)
Beschrijving

CTCAdverseEventTerm,Other

Datatype

text

Comments
Beschrijving

Comments

Comments
Beschrijving

Comments

Datatype

text

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

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
SWOGPatientID
Item
SWOG Patient ID
text
SWOGStudyNo.
Item
SWOG Study No.
text
RegistrationStep
Item
Registration Step
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)
Cycle Number Chemotherapeutics
Item
Cycle Number
float
C2045829 (UMLS CUI-1)
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-2)
C1522326 (UMLS 2011AA ObjectClass-2)
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
Ispatientstillonprotocoltreatment?
Item
Is patient still on protocol treatment?
boolean
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
Weretoxicitiesassessedduringthistimeperiod?
Item
Were toxicities assessed during this time period?
boolean
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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