ID

10581

Description

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

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 5/28/15 5/28/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Treatment Form - Autologous Transplant NCT00049517

English

No Instruction available.

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

ECOG clinical trial administrative data

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Registration Step
Description

RegistrationStep

Data type

text

Patient?s Name
Description

Patient'sName

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Data type

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

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

AmendedDataInd

Data type

boolean

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

Vital Status

Patient?s Vital Status
Description

Patient'sVitalStatus

Data type

text

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

DeathDate/LastContactDate

Data type

date

Cause of Death (if applicable)
Description

Causeofdeath

Data type

text

High Dose Cytarabine Consolidation Therapy
Description

High Dose Cytarabine Consolidation Therapy

Cycle Number
Description

CycleNumber

Data type

text

Patient weight
Description

PatientWeight

Data type

float

Treatment Start Date
Description

TreatmentStartDate

Data type

date

GM-CSF Initial Dose
Description

AgentInitialDose

Data type

float

Treatment End Date
Description

TreatmentEndDate

Data type

date

Peripheral Bood Stem Cell Harvest
Description

Peripheral Bood Stem Cell Harvest

Date of initial PBSC harvest
Description

DateofinitialPBSCharvest

Data type

text

Total no. of CD34+ cells harvested
Description

Totalno.ofCD34+cellsharvested

Data type

text

Gemtuzumab-ozogamicin Consolidation Therapy
Description

Gemtuzumab-ozogamicin Consolidation Therapy

Cyclophosphamide Total Dose
Description

AgentTotalDose

Data type

float

Transplant Conditioning Regimen
Description

Transplant Conditioning Regimen

Pbsc Reinfusion
Description

Pbsc Reinfusion

Date of last peripheral blood stem cell infusion
Description

Dateoflastperipheralbloodstemcellinfusion

Data type

text

Total number of CD34+ cells infused
Description

Totalno.ofCD34+cellsinfused

Data type

text

Transfusions
Description

Transfusions

Number of post-transplant platelet transfusions
Description

Numberofpost-transplantplatelettransfusions

Data type

text

Date of most recent platelet transfusion
Description

PlateletTransfusionReceivedMostRecentDate

Data type

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
Description

Numberofpost-transplantRBCtransfusions

Data type

text

Date of most recent RBC transfusion
Description

PackedRedBloodCellTransfusionReceivedMostRecentDate

Data type

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)
Description

OffTreatmentReason

Data type

text

Specify complicating disease (reason treatment ended)
Description

OffTreatmentReason,ComplicatingDisease

Data type

text

Specify other Reasons (reason treatment ended)
Description

OffTreatmentReason,Other

Data type

text

Comments
Description

Comments

Comments
Description

Comments

Data type

text

Investigator Signature
Description

InvestigatorSignature

Data type

text

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

InvestigatorSignatureDate

Data type

date

Ccrr Module For Treatment Form - Autologous Transplant
Description

Ccrr Module For Treatment Form - Autologous Transplant

Agent Name
Description

AgentName

Data type

text

Back to the top of the page

Similar models

No Instruction available.

1 forms
  1. StudyEvent: Treatment Form - Autologous Transplant
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
CL.2
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
CL.3
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
CL.4
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
CL.5
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
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial