ID

6782

Beschreibung

E1609 Long-Term Follow-up Form Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III or Stage IV Melanoma That Has Been Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=97EE23A9-7DEA-11D3-E040-BB89AD437097

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=97EE23A9-7DEA-11D3-E040-BB89AD437097

Stichworte

Klinische Studie [Dokumenttyp]

Melanom

Verlaufsstudien

19.09.12 19.09.12 -
08.01.15 08.01.15 - Martin Dugas

Hochgeladen am

8. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Melanoma (Skin) NCT01274338 Follow-Up - E1609 Long-Term Follow-up Form - 3173517v1.0

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Details

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule). Submit original to the ECOG Coordinating Center. Keep a copy for your files. NOTE: This form is required at the specified report periods regardless of whether new information is available

1 Formulare

StudyEvent: E1609 Long-Term Follow-up Form
1. INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule). Submit original to the ECOG Coordinating Center. Keep a copy for your files. NOTE: This form is required at the specified report periods regardless of whether new information is available

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header Module

Item Group

Header

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)

Registration Number

Item

Registration Step (Place ID Label Here)

text

C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)

Patient Initials

Item

Patient Initials (Last, First)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Study Number Participating Group

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

OFF TREATMENT

Item Group

Off Treatment

PersonOff-TreatmentTimePeriodType

Item

Off Treatment Report Period (Choose one)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.1

Code List

Off Treatment Report Period (Choose one)

CL Item

3 Months (3 Months Post Registration)

CL Item

6 Months (6 Months Post Registration)

CL Item

9 Months (9 Months Post Registration)

CL Item

12 Months (12 Months Post Registration)

CL Item

15 Months (15 Months Post Registration)

CL Item

18 Months (18 Months Post Registration)

CL Item

21 Months Post Registration (21 Months Post Registration)

CL Item

2 Years (24 Months Post Registration)

CL Item

30 Months (30 Months Post Registration)

CL Item

3 Years (36 Months Post Registration)

CL Item

42 Months (42 Months Post Registration)

CL Item

4 Years (48 Months Post Registration)

CL Item

54 Months (54 Months Post Registration)

CL Item

5 Years (60 Months Post Registration)

CL Item

6 Years (72 Months Post Registration)

CL Item

84 Months Post Registration (84 Months Post Registration)

CL Item

8 Years (96 months post registration)

CL Item

9 Years (108 months post registration)

CL Item

10 Years (120 months post registration)

CL Item

11 Years Post Registration (132 Months Post Registration)

CL Item

12 Years Post Registration (144 Months Post Registration)

CL Item

13 Years Post Registration (156 Months Post Registration)

CL Item

14 Years Post Registration (168 Months Post Registration)

CL Item

15 Years Post Registration (180 Months Post Registration)

CL Item

16 Years Post Registration (192 Months Post Registration)

CL Item

17 Years Post Registration (204 Months Post Registration)

CL Item

18 Years Post Registration (216 Months Post Registration)

CL Item

19 Years Post Registration (228 Months Post Registration)

CL Item

20 Years Post Registration (240 Months Post Registration)

Header

Item Group

Unnamed2

Data amended

Item

Please mark an 'X' if data have been amended. (Please circle amended items in red)

text

C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Data amended date

Item

Date data amended (s M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

ECOG Performance Status

Item Group

Ecog Performance Status

ECOG Performance Status

Item

ECOG Performance Status

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.2

Code List

ECOG Performance Status

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

CL Item

Dead (5)

Section I - Vital Status

Item Group

Vital Status

Patient Status

Item

Patient's Vital Status

text

C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)

CL.3

Code List

Patient's Vital Status

CL Item

Alive (Alive)

CL Item

Dead (Dead)

Date last contact

Item

Date of Last Contact or Death (m d y)

date

C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Primary Cause of Death

Item

Primary Cause of Death (if applicable)

text

C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)

CL.4

Code List

Primary Cause of Death (if applicable)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To This Disease (Due to this disease)

CL Item

Due To Other Cause (Due to other cause)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Cause of Death, specify

Item

Describe cause of death

text

C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)

Section II - Reporting Period

Item Group

Section Ii - Reporting Period

Reporting Period Start Date

Item

Reporting Period Start Date (M D Y)

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

Reporting Period End Date

Item

Reporting Period End Date (M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)

Section III - Notice of New Primary

Item Group

Section Iv - Notice Of New Primary

NewCancerDiagnosisInd-3

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.5

Code List

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

NewCancerSiteText

Item

Site of new primary (s If new primary site is AML/MDS/ALL, submit NCI AML/MDS/ALL form If new primary site is other than AML/MDS/ALL, submit ECOG Second Primary Form)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)

Section IV - Disease Follow-up Status

Item Group

Section Iii - Disease Follow-up Status

Documented clinical assessment for this cancer

Item

Has the patient had a documented clinical assessment for this cancer?

text

C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)

CL.6

Code List

Has the patient had a documented clinical assessment for this cancer?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CancerUnknownFollow-upAssessmentSpecify

Item

If unknown, please explain

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17998 (NCI Thesaurus Property-2)
C0439673 (UMLS 2011AA Property-2)
C16033 (NCI Thesaurus Property-3)
C1522577 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Follow-Up Date

Item

Date of last clinical assessment (If yes M D Y Submit Follow-up Disease Evaluation Form RECIST)

date

C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

DiseaseProgressionInd-3

Item

Has the patient developed a first progression that has not been previously reported? (or relapse)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

CL.7

Code List

Has the patient developed a first progression that has not been previously reported? (or relapse)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

ProgressiveDiseaseUnknownAssessmentSpecify

Item

If unknown, please explain

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25254 (NCI Thesaurus ObjectClass-2)
C0205329 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17998 (NCI Thesaurus Property-2)
C0439673 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

DiseaseProgressionDate

Item

Date of progression (relapse Submit Follow-up Disease Evaluation Form RECIST)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

Progression Sites

Item

Site(s) of progression

text

C25704 (NCI Thesaurus ValueDomain)
C0280457 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C25331 (NCI Thesaurus ObjectClass)

PhysicianProgressiveDiagnosisInd-3

Item

Did a physician make a formal diagnosis of progressive disease?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25254 (NCI Thesaurus Property)
C0205329 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)

CL.8

Code List

Did a physician make a formal diagnosis of progressive disease?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

ProgressionDiagnosisSpecify

Item

Specify basis of progression (If no or unknown )

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

Section V - Salvage Therapy

Item Group

Section V - Salvage Therapy

SalvageTherapyAdministeredInd-3

Item

Has the patient received any salvage therapy after recurrence

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15359 (NCI Thesaurus ObjectClass)
C0085405 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

SalvageTherapyIdentifierType

Item

Type of Salvage Therapy

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15359 (NCI Thesaurus ObjectClass)
C0085405 (UMLS 2011AA ObjectClass)

CL.10

Code List

Type of Salvage Therapy

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

CL Item

Radiation Therapy (Radiation Therapy)

C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)

CL Item

Immunotherapy (Immunotherapy)

C15262 (NCI Thesaurus)
C0021083 (UMLS 2011AA)

CL Item

Chemotherapy (Chemotherapy)

C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)

CL Item

Anti-pd1 Antibody (Anti-PD1 antibody)

CL Item

Anti-pd-l1 Antibody (Anti-PDL1 antibody)

SalvageTherapyAnti-PD-1MonoclonalAntibodyAdministerSpecify

Item

Anti-PD1 antibody, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15359 (NCI Thesaurus ObjectClass)
C0085405 (UMLS 2011AA ObjectClass)
C71014 (NCI Thesaurus Property)
C2346821 (UMLS 2011AA Property)
C64912 (NCI Thesaurus Property-2)
C1621583 (UMLS 2011AA Property-2)

SalvageTherapyAnti-PD-1MonoclonalAntibodyOtherAdministerSpecify

Item

Anti-PDL1 antibody, specify

text

C15359 (NCI Thesaurus ObjectClass)
C0085405 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C71014 (NCI Thesaurus Property-2)
C2346821 (UMLS 2011AA Property-2)
C64912 (NCI Thesaurus Property-3)
C1621583 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

SalvageTherapyAdministeredDate

Item

Date of salvage therapy (if applicable)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15359 (NCI Thesaurus ObjectClass)
C0085405 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

SalvageTherapyReceiveType

Item

Did the patient receive any of the following as part of salvage therapy

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15359 (NCI Thesaurus ObjectClass)
C0085405 (UMLS 2011AA ObjectClass)

CL.11

Code List

Did the patient receive any of the following as part of salvage therapy

CL Item

Interferon Alpha (Interferon-alpha)

C20494 (NCI Thesaurus)
C1610033 (UMLS 2011AA)

CL Item

Ipilimumab (Ipilimumab)

C2654 (NCI Thesaurus)
C1367202 (UMLS 2011AA)

CL Item

Tremelimumab (Tremelimumab)

C49085 (NCI Thesaurus)
C1367202 (UMLS 2011AA)

CL Item

Plx4032 (rg7204; Ro5185426) (PLX4032 (RG7204; RO5185426))

CL Item

Braf Inhibitor Gsk2118436 (GSK2118436)

C82386 (NCI Thesaurus)
C2826139 (UMLS 2011AA)

CL Item

Raf265 (RAF265)

CL Item

Other (Other)

SalvageTherapyReceiveSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15359 (NCI Thesaurus ObjectClass)
C0085405 (UMLS 2011AA ObjectClass)

Non-ProtocolSystemicTherapyAdministeredDate

Item

Date of any other non-protocol systemic treatment

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Section VI - BRAF Mutation

Item Group

Unnamed3

LaboratoryProcedureBRAFGeneOutcomeInd-2

Item

Was BRAF Gene Analysis performed (If yes, submit E1609 Source Document Tracking Coversheet)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C18363 (NCI Thesaurus Property-2)
C0812241 (UMLS 2011AA Property-2)

LaboratoryProcedureBRAFGeneOutcomeType

Item

BRAF Mutation Result (If Yes:)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C18363 (NCI Thesaurus Property-2)
C0812241 (UMLS 2011AA Property-2)

CL.13

Code List

BRAF Mutation Result (If Yes:)

CL Item

Wild Type (Wild Type)

C62195 (NCI Thesaurus)
C1883559 (UMLS 2011AA)

CL Item

V600e (V600E)

CL Item

V600k (V600K)

CL Item

Other (Other)

CL Item

Unknown (Unknown)

LaboratoryProcedureBRAFGeneOutcomeSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C18363 (NCI Thesaurus Property-2)
C0812241 (UMLS 2011AA Property-2)

LaboratoryProcedureBRAFGeneOutcomeDate

Item

Date of Test (BRAF Mutation)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C18363 (NCI Thesaurus Property-2)
C0812241 (UMLS 2011AA Property-2)

Section VI - Adverse Events

Item Group

Section V - Adverse Events

AdverseEventPriorCancerProgressionRecurrentNeoplasmPresentInd-3

Item

Has the patient experienced any reportable long term toxicity that has not been previously reported (prior to diagnosis of progression/relapse)

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C19987 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C4798 (NCI Thesaurus Property-4)
C0521158 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.14

Code List

Has the patient experienced any reportable long term toxicity that has not been previously reported (prior to diagnosis of progression/relapse)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Section VII - Non-Protocol Therapy Prior To Progression

Item Group

Section Vi - Non-protocol Therapy Prior To Progression

Non-ProtocolTherapyPriorCancerProgressionAdministrationInd-3

Item

Has the patient received any non-protocol cancer therapy prior to first progression (If yes, submit ECOG Non-Protocol Therapy Form - Note: Only the first occurrence of non-protocol therapy should be reported.)

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property-2)
C0242656 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.15

Code List

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Footer Module

Item Group

Comments

Investigator Signature

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

Investigator Signature Date

Item

Investigator Signature Date (M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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Item Kommentare für :

Melanoma (Skin) NCT01274338 Follow-Up - E1609 Long-Term Follow-up Form - 3173517v1.0

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