ID

1943

Beschreibung

Treatment Form - Autologous Transplant 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

Stichworte

  1. 19.09.12 19.09.12 -
  2. 28.05.15 28.05.15 -
  3. 03.06.15 03.06.15 -
Hochgeladen am

19. September 2012

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Leukemia NCT00049517 Treatment - Treatment Form - Autologous Transplant - 2053809v3.0

No Instruction available.

  1. StudyEvent: Treatment Form - Autologous Transplant
    1. No Instruction available.
Unnamed1
Beschreibung

Unnamed1

Registration Step
Beschreibung

RegistrationStep

Datentyp

text

Patient?s Name
Beschreibung

Patient'sName

Datentyp

text

ECOG Protocol No.
Beschreibung

ECOGProtocolNo.

Datentyp

text

ECOG Protocol No.
Beschreibung

ECOGProtocolNo.

Datentyp

text

ECOG Patient ID
Beschreibung

ECOGPatientID

Datentyp

text

ECOG Patient ID
Beschreibung

ECOGPatientID

Datentyp

text

Participating Group Protocol No.
Beschreibung

ParticipatingGroupProtocolNo.

Datentyp

text

Participating Group Patient ID
Beschreibung

ParticipatingGroupPatientID

Datentyp

text

Institution/Affiliate
Beschreibung

MainMemberInstitution/Affiliate

Datentyp

text

Unnamed2
Beschreibung

Unnamed2

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

AmendedDataInd

Datentyp

text

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

Vital Status

Patient?s Vital Status
Beschreibung

Patient'sVitalStatus

Datentyp

text

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

DeathDate/LastContactDate

Datentyp

date

Cause of Death (if applicable)
Beschreibung

Causeofdeath

Datentyp

text

High Dose Cytarabine Consolidation Therapy
Beschreibung

High Dose Cytarabine Consolidation Therapy

Cycle Number
Beschreibung

CycleNumber

Datentyp

text

Patient weight
Beschreibung

PatientWeight

Datentyp

double

Treatment Start Date
Beschreibung

TreatmentStartDate

Datentyp

date

Treatment Start Date
Beschreibung

TreatmentStartDate

Datentyp

date

Treatment End Date
Beschreibung

TreatmentEndDate

Datentyp

date

GM-CSF Initial Dose
Beschreibung

AgentInitialDose

Datentyp

double

GM-CSF Initial Dose
Beschreibung

AgentInitialDose

Datentyp

double

Peripheral Bood Stem Cell Harvest
Beschreibung

Peripheral Bood Stem Cell Harvest

Date of initial PBSC harvest
Beschreibung

DateofinitialPBSCharvest

Datentyp

text

Total no. of CD34+ cells harvested
Beschreibung

Totalno.ofCD34+cellsharvested

Datentyp

text

Gemtuzumab-ozogamicin Consolidation Therapy
Beschreibung

Gemtuzumab-ozogamicin Consolidation Therapy

Patient weight
Beschreibung

PatientWeight

Datentyp

double

Cyclophosphamide Total Dose
Beschreibung

AgentTotalDose

Datentyp

double

Treatment Start Date
Beschreibung

TreatmentStartDate

Datentyp

date

Treatment Start Date
Beschreibung

TreatmentStartDate

Datentyp

date

Treatment End Date
Beschreibung

TreatmentEndDate

Datentyp

date

GM-CSF Initial Dose
Beschreibung

AgentInitialDose

Datentyp

double

Transplant Conditioning Regimen
Beschreibung

Transplant Conditioning Regimen

Cyclophosphamide Total Dose
Beschreibung

AgentTotalDose

Datentyp

double

Cyclophosphamide Total Dose
Beschreibung

AgentTotalDose

Datentyp

double

Treatment Start Date
Beschreibung

TreatmentStartDate

Datentyp

date

Treatment End Date
Beschreibung

TreatmentEndDate

Datentyp

date

Pbsc Reinfusion
Beschreibung

Pbsc Reinfusion

Date of last peripheral blood stem cell infusion
Beschreibung

Dateoflastperipheralbloodstemcellinfusion

Datentyp

text

Total number of CD34+ cells infused
Beschreibung

Totalno.ofCD34+cellsinfused

Datentyp

text

Transfusions
Beschreibung

Transfusions

Number of post-transplant platelet transfusions
Beschreibung

Numberofpost-transplantplatelettransfusions

Datentyp

text

Date of most recent platelet transfusion
Beschreibung

PlateletTransfusionReceivedMostRecentDate

Datentyp

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
C25577
UMLS 2011AA ValueDomain
C1513491
Number of post-transplant RBC transfusions
Beschreibung

Numberofpost-transplantRBCtransfusions

Datentyp

text

Date of most recent RBC transfusion
Beschreibung

PackedRedBloodCellTransfusionReceivedMostRecentDate

Datentyp

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
C25577
UMLS 2011AA ValueDomain
C1513491
Reason Treatment Ended (Choose one)
Beschreibung

OffTreatmentReason

Datentyp

text

Specify complicating disease (reason treatment ended)
Beschreibung

OffTreatmentReason,ComplicatingDisease

Datentyp

text

Specify other Reasons (reason treatment ended)
Beschreibung

OffTreatmentReason,Other

Datentyp

text

Comments
Beschreibung

Comments

Comments
Beschreibung

Comments

Datentyp

text

Investigator Signature
Beschreibung

InvestigatorSignature

Datentyp

text

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

InvestigatorSignatureDate

Datentyp

date

Ccrr Module For Treatment Form - Autologous Transplant
Beschreibung

Ccrr Module For Treatment Form - Autologous Transplant

Agent Name
Beschreibung

AgentName

Datentyp

text

Ähnliche Modelle

No Instruction available.

  1. StudyEvent: Treatment Form - Autologous Transplant
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
ECOGPatientID
Item
ECOG Patient ID
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
Item Group
Unnamed2
Item
Are data amended? (If yes, please circle amended items in red)
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Code List
Are data amended? (If yes, please circle amended items in red)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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
double
TreatmentStartDate
Item
Treatment Start Date
date
TreatmentStartDate
Item
Treatment Start Date
date
TreatmentEndDate
Item
Treatment End Date
date
AgentInitialDose
Item
GM-CSF Initial Dose
double
AgentInitialDose
Item
GM-CSF Initial Dose
double
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
PatientWeight
Item
Patient weight
double
AgentTotalDose
Item
Cyclophosphamide Total Dose
double
TreatmentStartDate
Item
Treatment Start Date
date
TreatmentStartDate
Item
Treatment Start Date
date
TreatmentEndDate
Item
Treatment End Date
date
AgentInitialDose
Item
GM-CSF Initial Dose
double
Item Group
Transplant Conditioning Regimen
AgentTotalDose
Item
Cyclophosphamide Total Dose
double
AgentTotalDose
Item
Cyclophosphamide Total Dose
double
TreatmentStartDate
Item
Treatment Start Date
date
TreatmentEndDate
Item
Treatment End Date
date
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)
C1513491 (UMLS 2011AA ValueDomain)
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)
C1513491 (UMLS 2011AA ValueDomain)
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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