ID

1864

Description

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

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

September 19, 2012

DOI

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License

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
Description

Calgb Form

CALGB Study No.
Description

CALGBProtocolNumber

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

Are data amended?
Description

AmendedDataInd

Data type

text

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

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Participating Group
Description

ParticipatingGroup

Data type

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital No.
Description

PatientHospitalNumber

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

Participating Group Patient ID:
Description

ParticipatingGroupPatientID

Data type

text

Reporting period Start Date
Description

IntervalReportFromDate

Data type

date

Reporting period Start Date
Description

IntervalReportFromDate

Data type

date

Reporting period End Date (MM DD YYYY)
Description

IntervalReportToDate

Data type

date

Reporting period End Date (MM DD YYYY)
Description

IntervalReportToDate

Data type

date

Treatment Phase Information
Description

Treatment Phase Information

Treatment Phase (Mark one with an X)
Description

TreatmentPhase

Data type

text

Other, specify (treatment phase)
Description

TreatmentPhase,Other

Data type

text

Leukemia Treatment Plan
Description

Leukemia Treatment Plan

Did the patient receive any protocol treatment?
Description

ProtocolTreatmentInd

Data type

text

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

TreatmentFirstDoseBeginDate

Data type

date

Number of courses or cycles given this reporting period
Description

TotalCourseNumber

Data type

double

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

TreatmentLastDoseEndDate

Data type

date

G3139 (dose) (mg)
Description

AgentTotalDose

Data type

double

G3139 (dose) (mg)
Description

AgentTotalDose

Data type

double

G3139 (dose) (mg)
Description

AgentTotalDose

Data type

double

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

OffTreatmentReason

Data type

text

Other, specify (reason treatment ended)
Description

OffTreatmentReason,Other

Data type

text

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

DoseModification(Change)

Data type

text

If yes, unplanned, specify change
Description

DoseModificationReason

Data type

text

Completed by (First Name, Last Name)
Description

CompletedBy

Data type

text

Ccrr Module For Calgb: 10201 Treatment Form
Description

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
Type
Description | Question | Decode (Coded Value)
Data type
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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