ID

10581

Beschrijving

Treatment Form - Autologous Transplant NCT00049517 Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A727E609-20CC-2F84-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A727E609-20CC-2F84-E034-0003BA0B1A09

Trefwoorden

  1. 19-09-12 19-09-12 -
  2. 28-05-15 28-05-15 -
  3. 03-06-15 03-06-15 -
Geüploaded op

3 juni 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Treatment Form - Autologous Transplant NCT00049517

No Instruction available.

  1. StudyEvent: Treatment Form - Autologous Transplant
    1. No Instruction available.
ECOG clinical trial administrative data
Beschrijving

ECOG clinical trial administrative data

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

Registration Step
Beschrijving

RegistrationStep

Datatype

text

Patient?s Name
Beschrijving

Patient'sName

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Participating Group Patient ID
Beschrijving

ParticipatingGroupPatientID

Datatype

text

Institution/Affiliate
Beschrijving

MainMemberInstitution/Affiliate

Datatype

text

Are data amended? (If yes, please circle amended items in red)
Beschrijving

AmendedDataInd

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Vital Status
Beschrijving

Vital Status

Patient?s Vital Status
Beschrijving

Patient'sVitalStatus

Datatype

text

Date of Last Contact or Death (M D Y)
Beschrijving

DeathDate/LastContactDate

Datatype

date

Cause of Death (if applicable)
Beschrijving

Causeofdeath

Datatype

text

High Dose Cytarabine Consolidation Therapy
Beschrijving

High Dose Cytarabine Consolidation Therapy

Cycle Number
Beschrijving

CycleNumber

Datatype

text

Patient weight
Beschrijving

PatientWeight

Datatype

float

Treatment Start Date
Beschrijving

TreatmentStartDate

Datatype

date

GM-CSF Initial Dose
Beschrijving

AgentInitialDose

Datatype

float

Treatment End Date
Beschrijving

TreatmentEndDate

Datatype

date

Peripheral Bood Stem Cell Harvest
Beschrijving

Peripheral Bood Stem Cell Harvest

Date of initial PBSC harvest
Beschrijving

DateofinitialPBSCharvest

Datatype

text

Total no. of CD34+ cells harvested
Beschrijving

Totalno.ofCD34+cellsharvested

Datatype

text

Gemtuzumab-ozogamicin Consolidation Therapy
Beschrijving

Gemtuzumab-ozogamicin Consolidation Therapy

Cyclophosphamide Total Dose
Beschrijving

AgentTotalDose

Datatype

float

Transplant Conditioning Regimen
Beschrijving

Transplant Conditioning Regimen

Pbsc Reinfusion
Beschrijving

Pbsc Reinfusion

Date of last peripheral blood stem cell infusion
Beschrijving

Dateoflastperipheralbloodstemcellinfusion

Datatype

text

Total number of CD34+ cells infused
Beschrijving

Totalno.ofCD34+cellsinfused

Datatype

text

Transfusions
Beschrijving

Transfusions

Number of post-transplant platelet transfusions
Beschrijving

Numberofpost-transplantplatelettransfusions

Datatype

text

Date of most recent platelet transfusion
Beschrijving

PlateletTransfusionReceivedMostRecentDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C15366
UMLS 2011AA ObjectClass
C0086818
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Number of post-transplant RBC transfusions
Beschrijving

Numberofpost-transplantRBCtransfusions

Datatype

text

Date of most recent RBC transfusion
Beschrijving

PackedRedBloodCellTransfusionReceivedMostRecentDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C15409
UMLS 2011AA ObjectClass
C0199962
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Reason Treatment Ended (Choose one)
Beschrijving

OffTreatmentReason

Datatype

text

Specify complicating disease (reason treatment ended)
Beschrijving

OffTreatmentReason,ComplicatingDisease

Datatype

text

Specify other Reasons (reason treatment ended)
Beschrijving

OffTreatmentReason,Other

Datatype

text

Comments
Beschrijving

Comments

Comments
Beschrijving

Comments

Datatype

text

Investigator Signature
Beschrijving

InvestigatorSignature

Datatype

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Beschrijving

InvestigatorSignatureDate

Datatype

date

Ccrr Module For Treatment Form - Autologous Transplant
Beschrijving

Ccrr Module For Treatment Form - Autologous Transplant

Agent Name
Beschrijving

AgentName

Datatype

text

Similar models

No Instruction available.

  1. StudyEvent: Treatment Form - Autologous Transplant
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
ECOG clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended? (If yes, please circle amended items in red)
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Vital Status
Item
Patient?s Vital Status
text
Code List
Patient?s Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
DeathDate/LastContactDate
Item
Date of Last Contact or Death (M D Y)
date
Item
Cause of Death (if applicable)
text
Code List
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)
Item Group
High Dose Cytarabine Consolidation Therapy
Item
Cycle Number
text
Code List
Cycle Number
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 2 (Cycle 2)
PatientWeight
Item
Patient weight
float
TreatmentStartDate
Item
Treatment Start Date
date
AgentInitialDose
Item
GM-CSF Initial Dose
float
TreatmentEndDate
Item
Treatment End Date
date
Item Group
Peripheral Bood Stem Cell Harvest
DateofinitialPBSCharvest
Item
Date of initial PBSC harvest
text
Totalno.ofCD34+cellsharvested
Item
Total no. of CD34+ cells harvested
text
Item Group
Gemtuzumab-ozogamicin Consolidation Therapy
AgentTotalDose
Item
Cyclophosphamide Total Dose
float
Item Group
Transplant Conditioning Regimen
Item Group
Pbsc Reinfusion
Dateoflastperipheralbloodstemcellinfusion
Item
Date of last peripheral blood stem cell infusion
text
Totalno.ofCD34+cellsinfused
Item
Total number of CD34+ cells infused
text
Item Group
Transfusions
Numberofpost-transplantplatelettransfusions
Item
Number of post-transplant platelet transfusions
text
PlateletTransfusionReceivedMostRecentDate
Item
Date of most recent platelet transfusion
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
Numberofpost-transplantRBCtransfusions
Item
Number of post-transplant RBC transfusions
text
PackedRedBloodCellTransfusionReceivedMostRecentDate
Item
Date of most recent RBC transfusion
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
Item
Reason Treatment Ended (Choose one)
text
Code List
Reason Treatment Ended (Choose one)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Death After Beginning Protocol Therapy (Death after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Other complicating disease)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OffTreatmentReason,ComplicatingDisease
Item
Specify complicating disease (reason treatment ended)
text
OffTreatmentReason,Other
Item
Specify other Reasons (reason treatment ended)
text
Item Group
Comments
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
Item Group
Ccrr Module For Treatment Form - Autologous Transplant
AgentName
Item
Agent Name
text

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