ID

7480

Beschreibung

E2906 Acute Graft vs. Host Disease Form - Arm G Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=758358AD-52B1-2ABE-E040-BB89AD430F03

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=758358AD-52B1-2ABE-E040-BB89AD430F03

Stichworte

  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Leukemia NCT01041703 Treatment - E2906 Acute Graft vs. Host Disease Form - Arm G - 2951629v1.0

INSTRUCTIONS: Complete at 100 days and 1 year post transplant . Submit original to the ECOG Coordinating Center. Keep a copy for your files

Header
Beschreibung

Header

DCI Name
Beschreibung

Generic drug form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step (Place ID Label Here)
Beschreibung

Registration Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (Last, First)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Protocol Number
Beschreibung

Protocol Number ECOG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Protocol Number
Beschreibung

Protocol Number ECOG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beschreibung

Patient ID ECOG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beschreibung

Patient ID ECOG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Participating Group Protocol Number
Beschreibung

Study Number Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beschreibung

Trial subject ID Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Beschreibung

Institution Name

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
On Treatment
Beschreibung

On Treatment

Report Period
Beschreibung

Clinical Trial Period

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Unnamed2
Beschreibung

Unnamed2

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

Data amended

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s M D Y)
Beschreibung

Data amended date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Gvhd Information
Beschreibung

Gvhd Information

Did acute GVHD occur
Beschreibung

TransplantAcuteGVHDOccurrenceInd

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Thesaurus Property
C14140
UMLS 2011AA Property
C0205178
NCI Metathesaurus Property
C0018133
Acute GVHD onset date (M D Y If yes)
Beschreibung

TransplantAcuteGVHDBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Thesaurus Property
C14140
UMLS 2011AA Property
C0205178
NCI Metathesaurus Property
C0018133
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Acute GVHD end date (M D Y If yes)
Beschreibung

TransplantAcuteGVHDEndDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Thesaurus Property
C14140
UMLS 2011AA Property
C0205178
NCI Metathesaurus Property
C0018133
Gvhd Prophylaxis
Beschreibung

Gvhd Prophylaxis

Specify therapy used to treat acute GVHD (Record an answer "yes" or "no" for each of the following)
Beschreibung

MedicationGraftVersusHostDiseaseAdministeredType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Metathesaurus ObjectClass
C0018133
Other, specify
Beschreibung

AcuteGraftVersusHostDIseaseTransplantTreatmentText

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C14140
UMLS 2011AA ObjectClass
C0205178
NCI Metathesaurus ObjectClass
C0018133
NCI Thesaurus Property
C12981
UMLS 2011AA Property
C0332835
NCI Thesaurus Property-2
C15368
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Agent Name
Beschreibung

Agent

Datentyp

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Date Agent Administered (M D Y Day+1 Day+3 Day+6 Day+11)
Beschreibung

Agent Administered Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0450442
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
UMLS CUI-3
C0011008
Agent Dose (mg)
Beschreibung

Medication Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS CUI-1
C3174092
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain-2
C1708
NCI Thesaurus Property
C25382
Comments
Beschreibung

Comments

Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date (MM DD YYYY)
Beschreibung

Investigator Signature Date

Datentyp

date

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

Ähnliche Modelle

INSTRUCTIONS: Complete at 100 days and 1 year post transplant . Submit original to the ECOG Coordinating Center. Keep a copy for your files

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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)
Item Group
On Treatment
Item
Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
Code List
Report Period
CL Item
100 Days Post Transplant (100 Days Post Transplant)
CL Item
1 Year Post Transplant (1 Year Post Transplant)
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)
Item Group
Gvhd Information
TransplantAcuteGVHDOccurrenceInd
Item
Did acute GVHD occur
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C14140 (NCI Thesaurus Property)
C0205178 (UMLS 2011AA Property)
C0018133 (NCI Metathesaurus Property)
TransplantAcuteGVHDBeginDate
Item
Acute GVHD onset date (M D Y If yes)
date
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C14140 (NCI Thesaurus Property)
C0205178 (UMLS 2011AA Property)
C0018133 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
TransplantAcuteGVHDEndDate
Item
Acute GVHD end date (M D Y If yes)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C14140 (NCI Thesaurus Property)
C0205178 (UMLS 2011AA Property)
C0018133 (NCI Metathesaurus Property)
Item Group
Gvhd Prophylaxis
Item
Specify therapy used to treat acute GVHD (Record an answer "yes" or "no" for each of the following)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C0018133 (NCI Metathesaurus ObjectClass)
Code List
Specify therapy used to treat acute GVHD (Record an answer "yes" or "no" for each of the following)
CL Item
Tacrolimus (Tacrolimus)
C1311 (NCI Thesaurus)
C0085149 (UMLS 2011AA)
CL Item
Cyclosporine (cyclosporine)
C406 (NCI Thesaurus)
C0010592 (UMLS 2011AA)
CL Item
Daclizumab (Daclizumab)
C1569 (NCI Thesaurus)
C0281549 (UMLS 2011AA)
CL Item
Sirolimus (Rapamycin)
C1212 (NCI Thesaurus)
C0072980 (UMLS 2011AA)
CL Item
Mycophenolate Mofetil (Mycophenolate Mofetil)
C1468 (NCI Thesaurus)
C0209368 (UMLS 2011AA)
CL Item
Corticosteroid (Corticosteroids)
C2322 (NCI Thesaurus)
C0001617 (UMLS 2011AA)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AcuteGraftVersusHostDIseaseTransplantTreatmentText
Item
Other, specify
text
C14140 (NCI Thesaurus ObjectClass)
C0205178 (UMLS 2011AA ObjectClass)
C0018133 (NCI Metathesaurus ObjectClass)
C12981 (NCI Thesaurus Property)
C0332835 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Administered Date
Item
Date Agent Administered (M D Y Day+1 Day+3 Day+6 Day+11)
date
C25164 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
C0011008 (UMLS CUI-3)
Medication Dose
Item
Agent Dose (mg)
float
C25488 (NCI Thesaurus ValueDomain)
C3174092 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
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 (MM DD YYYY)
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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