ID

10580

Description

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

Lien

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

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 28/05/2015 28/05/2015 -
  3. 03/06/2015 03/06/2015 -
Téléchargé le

3 juin 2015

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0 Legacy
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E1900 Induction Treatment Form NCT00049517

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: E1900 Induction Treatment Form
    1. No Instruction available.
ECOG clinical trial administrative data
Description

ECOG clinical trial administrative data

ECOG Protocol No.
Description

ECOGProtocolNo.

Type de données

text

ECOG Patient ID
Description

ECOGPatientID

Type de données

text

Registration Step
Description

RegistrationStep

Type de données

text

Patient?s Name
Description

Patient'sName

Type de données

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Type de données

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Type de données

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Type de données

text

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

AmendedDataInd

Type de données

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

Type de données

text

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

DeathDate/LastContactDate

Type de données

date

Cause of Death (if applicable)
Description

Causeofdeath

Type de données

text

Describe cause of death
Description

DeathReason,Specify

Type de données

text

Treatment Cycle Information
Description

Treatment Cycle Information

Assigned Treatment Arm (Choose one)
Description

TreatmentArmNumber

Type de données

text

Cycle
Description

CourseIdentification

Type de données

text

Weight for this cycle (kg)
Description

PatientWeight

Type de données

float

Treatment Begin Date
Description

TreatmentBeginDate

Type de données

date

Cytarabine Initial Dose
Description

AgentInitialDose

Type de données

float

Number of days GM-CSF was given
Description

AgentDuration

Type de données

float

GM-CSF Total Cumulative Dose
Description

AgentTotalCumulativeDose

Type de données

float

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

Wasintrathecalmethotrexateorcytarabineadministered?

Type de données

boolean

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

DoseModification(Change)

Type de données

text

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

Non-ProtocolTherapyInd,DuringTreatment

Type de données

boolean

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

TreatmentEndDate

Type de données

date

Reason Treatment Ended (Choose one)
Description

OffTreatmentReason

Type de données

text

Specify complicating disease (reason treatment ended)
Description

OffTreatmentReason,ComplicatingDisease

Type de données

text

Specify other Reasons (reason treatment ended)
Description

OffTreatmentReason,Other

Type de données

text

Comments
Description

Comments

Comments
Description

Comments

Type de données

text

Investigator Signature
Description

InvestigatorSignature

Type de données

text

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

InvestigatorSignatureDate

Type de données

date

Ccrr Module For E1900 Induction Treatment Form
Description

Ccrr Module For E1900 Induction Treatment Form

Agent Name
Description

AgentName

Type de données

text

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Similar models

No Instruction available.

1 Formulaires
  1. StudyEvent: E1900 Induction Treatment Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
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)
float
TreatmentBeginDate
Item
Treatment Begin Date
date
AgentInitialDose
Item
Cytarabine Initial Dose
float
AgentDuration
Item
Number of days GM-CSF was given
float
AgentTotalCumulativeDose
Item
GM-CSF Total Cumulative Dose
float
Wasintrathecalmethotrexateorcytarabineadministered?
Item
Was intrathecal methotrexate or cytarabine administered? (choose one)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
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)
Non-ProtocolTherapyInd,DuringTreatment
Item
Was any non-protocol therapy given during protocol treatment? (not previously reported)
boolean
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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