ID

1864

Descrição

CALGB: 10201 Treatment FORM Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD83D624-B33F-3003-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD83D624-B33F-3003-E034-0003BA12F5E7

Palavras-chave

  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
Transferido a

19 de setembro de 2012

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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Leukemia NCT00085124 Treatment - CALGB: 10201 Treatment FORM - 2031608v3.0

Instructions: Complete and submit thie form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Cirlce amended items and check "Amended data" box to teh right. If submitting by mail, retain a copy for your records and send the original form for mazimum clarity in transmission and fax to 919-416-4990. If submistting electronically, click the Send button when you have completed the PDF version of the form.

Calgb Form
Descrição

Calgb Form

CALGB Study No.
Descrição

CALGBProtocolNumber

Tipo de dados

text

CALGB Patient ID
Descrição

CALGBPatientID

Tipo de dados

text

Are data amended?
Descrição

AmendedDataInd

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25474 (undefined)
UMLS 2011AA ObjectClass
C1511726 (Data)
NCI Thesaurus Property
C25416 (undefined)
UMLS 2011AA Property
C1691222 (Amended)
Patient's Initials (Last, First, Middle)
Descrição

PatientInitialsName

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25191 (undefined)
UMLS 2011AA ValueDomain
C1547383 (Person Name)
SNOMED
734006007
NCI Thesaurus ObjectClass
C16960 (undefined)
UMLS 2011AA ObjectClass
C0030705 (Patients)
SNOMED
116154003
NCI Thesaurus Property
C25536 (undefined)
UMLS 2011AA Property
C1555582 (Initial (abbreviation))
Participating Group
Descrição

ParticipatingGroup

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C17005 (undefined)
UMLS 2011AA ObjectClass
C1257890 (Population Group)
SNOMED
389109008
LOINC
LA12078-4
NCI Thesaurus Property
C25364 (undefined)
UMLS 2011AA Property
C0600091 (Identifier)
SNOMED
118522005
LOINC
LP31795-5
Patient Hospital No.
Descrição

PatientHospitalNumber

Tipo de dados

text

Participating Group Protocol No.
Descrição

ParticipatingGroupProtocolNo.

Tipo de dados

text

Institution/Affiliate
Descrição

MainMemberInstitution/Affiliate

Tipo de dados

text

Participating Group Patient ID:
Descrição

ParticipatingGroupPatientID

Tipo de dados

text

Reporting period Start Date
Descrição

IntervalReportFromDate

Tipo de dados

date

Reporting period Start Date
Descrição

IntervalReportFromDate

Tipo de dados

date

Reporting period End Date (MM DD YYYY)
Descrição

IntervalReportToDate

Tipo de dados

date

Reporting period End Date (MM DD YYYY)
Descrição

IntervalReportToDate

Tipo de dados

date

Treatment Phase Information
Descrição

Treatment Phase Information

Treatment Phase (Mark one with an X)
Descrição

TreatmentPhase

Tipo de dados

text

Other, specify (treatment phase)
Descrição

TreatmentPhase,Other

Tipo de dados

text

Leukemia Treatment Plan
Descrição

Leukemia Treatment Plan

Did the patient receive any protocol treatment?
Descrição

ProtocolTreatmentInd

Tipo de dados

text

Date of first dose for this reporting period (MM DD YYYY)
Descrição

TreatmentFirstDoseBeginDate

Tipo de dados

date

Number of courses or cycles given this reporting period
Descrição

TotalCourseNumber

Tipo de dados

double

Date of last dose for this reporting period (MM DD YYYY)
Descrição

TreatmentLastDoseEndDate

Tipo de dados

date

G3139 (dose) (mg)
Descrição

AgentTotalDose

Tipo de dados

double

G3139 (dose) (mg)
Descrição

AgentTotalDose

Tipo de dados

double

G3139 (dose) (mg)
Descrição

AgentTotalDose

Tipo de dados

double

If the treatment ended this period, reason treatment ended or not given (Mark one with an X)
Descrição

OffTreatmentReason

Tipo de dados

text

Other, specify (reason treatment ended)
Descrição

OffTreatmentReason,Other

Tipo de dados

text

Were there any dose modifications or additions/omissions to protocol treatment (Mark one with an X)
Descrição

DoseModification(Change)

Tipo de dados

text

If yes, unplanned, specify change
Descrição

DoseModificationReason

Tipo de dados

text

Completed by (First Name, Last Name)
Descrição

CompletedBy

Tipo de dados

text

Ccrr Module For Calgb: 10201 Treatment Form
Descrição

Ccrr Module For Calgb: 10201 Treatment Form

Similar models

Instructions: Complete and submit thie form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Cirlce amended items and check "Amended data" box to teh right. If submitting by mail, retain a copy for your records and send the original form for mazimum clarity in transmission and fax to 919-416-4990. If submistting electronically, click the Send button when you have completed the PDF version of the form.

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Calgb Form
CALGBProtocolNumber
Item
CALGB Study No.
text
CALGBPatientID
Item
CALGB Patient ID
text
AmendedDataInd
Item
Are data amended?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient's Initials (Last, First, Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital No.
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID:
text
IntervalReportFromDate
Item
Reporting period Start Date
date
IntervalReportFromDate
Item
Reporting period Start Date
date
IntervalReportToDate
Item
Reporting period End Date (MM DD YYYY)
date
IntervalReportToDate
Item
Reporting period End Date (MM DD YYYY)
date
Item Group
Treatment Phase Information
Item
Treatment Phase (Mark one with an X)
text
Code List
Treatment Phase (Mark one with an X)
CL Item
Current Phase Of Leukemia Treatment For Patient Is Induction (Induction)
CL Item
Current Phase Of Leukemia Treatment For Patient Is Consolidation (Consolidation)
CL Item
Current Phase Of Leukemia Treatment For Patient Is Follow-up, Or Patient Is Off Therapy (Follow-Up/Off Therapy)
CL Item
Current Phase Of Leukemia Treatment For Patient Is Specified Other Phase (Other, specify)
TreatmentPhase,Other
Item
Other, specify (treatment phase)
text
Item Group
Leukemia Treatment Plan
Item
Did the patient receive any protocol treatment?
text
Code List
Did the patient receive any protocol treatment?
CL Item
Null (No)
CL Item
Null (Yes)
TreatmentFirstDoseBeginDate
Item
Date of first dose for this reporting period (MM DD YYYY)
date
TotalCourseNumber
Item
Number of courses or cycles given this reporting period
double
TreatmentLastDoseEndDate
Item
Date of last dose for this reporting period (MM DD YYYY)
date
AgentTotalDose
Item
G3139 (dose) (mg)
double
AgentTotalDose
Item
G3139 (dose) (mg)
double
AgentTotalDose
Item
G3139 (dose) (mg)
double
Item
If the treatment ended this period, reason treatment ended or not given (Mark one with an X)
text
Code List
If the treatment ended this period, reason treatment ended or not given (Mark one with an X)
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
Progression Of Disease Occurred Prior To The Patient Beginning Protocol Therapy (Disease progression, relapse prior to beginning protocol therapy)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdraw or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdraw or refusal before beginning protocol therapy)
CL Item
Death Of Patient Occurred After The Patient Began Protocol Therapy (Death after beginning protocol therapy)
CL Item
Death Prior To Beginning Protocol Therapy (Death prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Other (Other complicating disease)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other, Specify (Other, specify)
OffTreatmentReason,Other
Item
Other, specify (reason treatment ended)
text
Item
Were there any dose modifications or additions/omissions to protocol treatment (Mark one with an X)
text
Code List
Were there any dose modifications or additions/omissions to protocol treatment (Mark one with an X)
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)
DoseModificationReason
Item
If yes, unplanned, specify change
text
CompletedBy
Item
Completed by (First Name, Last Name)
text
Item Group
Ccrr Module For Calgb: 10201 Treatment Form

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