ID

1961

Descrizione

E1900 Induction Treatment Form 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=A7294EC6-E15C-2FD0-E034-0003BA0B1A09

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7294EC6-E15C-2FD0-E034-0003BA0B1A09

Keywords

versioni (3)
  1. 19/09/12 19/09/12 -
  2. 28/05/15 28/05/15 -
  3. 03/06/15 03/06/15 -
Caricato su

19 settembre 2012

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00049517 Treatment - E1900 Induction Treatment Form - 2054254v3.0

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: E1900 Induction Treatment Form
    1. No Instruction available.
Unnamed1
Descrizione

Unnamed1

Registration Step
Descrizione

RegistrationStep

Tipo di dati

text

Patient?s Name
Descrizione

Patient'sName

Tipo di dati

text

ECOG Protocol No.
Descrizione

ECOGProtocolNo.

Tipo di dati

text

ECOG Protocol No.
Descrizione

ECOGProtocolNo.

Tipo di dati

text

ECOG Patient ID
Descrizione

ECOGPatientID

Tipo di dati

text

ECOG Patient ID
Descrizione

ECOGPatientID

Tipo di dati

text

Participating Group Protocol No.
Descrizione

ParticipatingGroupProtocolNo.

Tipo di dati

text

Participating Group Patient ID
Descrizione

ParticipatingGroupPatientID

Tipo di dati

text

Institution/Affiliate
Descrizione

MainMemberInstitution/Affiliate

Tipo di dati

text

Unnamed2
Descrizione

Unnamed2

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

AmendedDataInd

Tipo di dati

text

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

Vital Status

Patient?s Vital Status
Descrizione

Patient'sVitalStatus

Tipo di dati

text

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

DeathDate/LastContactDate

Tipo di dati

date

Cause of Death (if applicable)
Descrizione

Causeofdeath

Tipo di dati

text

Describe cause of death
Descrizione

DeathReason,Specify

Tipo di dati

text

Treatment Cycle Information
Descrizione

Treatment Cycle Information

Assigned Treatment Arm (Choose one)
Descrizione

TreatmentArmNumber

Tipo di dati

text

Cycle
Descrizione

CourseIdentification

Tipo di dati

text

Weight for this cycle (kg)
Descrizione

PatientWeight

Tipo di dati

double

Treatment Begin Date
Descrizione

TreatmentBeginDate

Tipo di dati

date

Cytarabine Initial Dose
Descrizione

AgentInitialDose

Tipo di dati

double

Cytarabine Initial Dose
Descrizione

AgentInitialDose

Tipo di dati

double

Number of days GM-CSF was given
Descrizione

AgentDuration

Tipo di dati

double

GM-CSF Total Cumulative Dose
Descrizione

AgentTotalCumulativeDose

Tipo di dati

double

Was intrathecal methotrexate or cytarabine administered? (choose one)
Descrizione

Wasintrathecalmethotrexateorcytarabineadministered?

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
Descrizione

DoseModification(Change)

Tipo di dati

text

Was any non-protocol therapy given during protocol treatment? (not previously reported)
Descrizione

Non-ProtocolTherapyInd,DuringTreatment

Tipo di dati

text

Last date (any modality of) protocol therapy was given
Descrizione

TreatmentEndDate

Tipo di dati

date

Reason Treatment Ended (Choose one)
Descrizione

OffTreatmentReason

Tipo di dati

text

Specify complicating disease (reason treatment ended)
Descrizione

OffTreatmentReason,ComplicatingDisease

Tipo di dati

text

Specify other Reasons (reason treatment ended)
Descrizione

OffTreatmentReason,Other

Tipo di dati

text

Comments
Descrizione

Comments

Comments
Descrizione

Comments

Tipo di dati

text

Investigator Signature
Descrizione

InvestigatorSignature

Tipo di dati

text

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

InvestigatorSignatureDate

Tipo di dati

date

Ccrr Module For E1900 Induction Treatment Form
Descrizione

Ccrr Module For E1900 Induction Treatment Form

Agent Name
Descrizione

AgentName

Tipo di dati

text

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Similar models

No Instruction available.

1 moduli
  1. StudyEvent: E1900 Induction Treatment Form
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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)
CL.1
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
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)
DeathReason,Specify
Item
Describe cause of death
text
Item Group
Treatment Cycle Information
Item
Assigned Treatment Arm (Choose one)
text
CL.4
Code List
Assigned Treatment Arm (Choose one)
CL Item
Arm A - Daunorubicin 45 mg/m2 (Arm A - Daunorubicin 45 mg/m2)
CL Item
Arm B - Daunorubicin 90 mg/m2 (Arm B - Daunorubicin 90 mg/m2)
Item
Cycle
text
CL.5
Code List
Cycle
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 2 (Cycle 2)
PatientWeight
Item
Weight for this cycle (kg)
double
TreatmentBeginDate
Item
Treatment Begin Date
date
AgentInitialDose
Item
Cytarabine Initial Dose
double
AgentInitialDose
Item
Cytarabine Initial Dose
double
AgentDuration
Item
Number of days GM-CSF was given
double
AgentTotalCumulativeDose
Item
GM-CSF Total Cumulative Dose
double
Item
Was intrathecal methotrexate or cytarabine administered? (choose one)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.6
Code List
Was intrathecal methotrexate or cytarabine administered? (choose one)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
text
CL.7
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
Item
Was any non-protocol therapy given during protocol treatment? (not previously reported)
text
CL.8
Code List
Was any non-protocol therapy given during protocol treatment? (not previously reported)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
TreatmentEndDate
Item
Last date (any modality of) protocol therapy was given
date
Item
Reason Treatment Ended (Choose one)
text
CL.9
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 E1900 Induction Treatment Form
AgentName
Item
Agent Name
text
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