ID

24000

Description

CALGB: OFF TREATMENT NOTICE Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Leukemia NCT00085124 Off Treatment - CALGB: OFF TREATMENT NOTICE - 2076876v3.0 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B229F9FE-3D25-514D-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B229F9FE-3D25-514D-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 7/21/17 7/21/17 - Martin Dugas
Uploaded on

July 21, 2017

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License

Creative Commons BY-NC 3.0
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AML Daunorubicin Cytarabine NCT00085124 CALGB

English

INSTRUCTIONS: Complete and submit this 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. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Data Management Center. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 forms  
Off Treatment Notice
Description

Off Treatment Notice

Alias
UMLS CUI-1
C1518544
CALGB Form
Description

CALGB Form

Data type

text

Alias
UMLS CUI [1,1]
C0376315
UMLS CUI [1,2]
C1516238
CALGB Study No
Description

CALGB Protocol Number

Data type

text

Alias
UMLS CUI [1,1]
C1516238
UMLS CUI [1,2]
C2603343
CALGB Patient ID
Description

CALGB Patient ID

Data type

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C1516238
Amended data?
Description

Amended Data

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
UMLS CUI [1,1]
C1511726
UMLS CUI [1,2]
C1691222
Patient's Name
Description

Patient's Name

Data type

text

Alias
UMLS CUI [1]
C1299487
Participating Group
Description

Participating Group Name

Data type

text

Alias
UMLS CUI [1]
C2347449
Patient Hospital Number
Description

Hospital Number

Data type

text

Alias
UMLS CUI [1]
C0806432
Participating Group Protocol No
Description

Participating Group Protocol Number

Data type

float

Alias
UMLS CUI [1,1]
C3274381
UMLS CUI [1,2]
C2347449
Main Member Institution/Adjunct
Description

Main Member Institution/Affiliate

Data type

text

Alias
UMLS CUI [1]
C1301943
Participating Group Patient No
Description

Participating Group Patient ID

Data type

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C2347449
REASON OFF TREATMENT
Description

(select ONE REASON ONLY by placing an X in the appropriate box)

Data type

text

Alias
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0566251
Patient developed other disease. Specify
Description

other disease

Data type

text

Alias
UMLS CUI [1]
C2359476
Reason why treatment was not started
Description

Reason treatment not started

Data type

text

Alias
UMLS CUI [1]
C3539764
Specify type of non-protocol treatment:
Description

Non-Protocol Therapy

Data type

text

Alias
NCI Thesaurus ObjectClass
C25590
NCI Thesaurus ObjectClass-2
C2167
NCI Thesaurus Property
C25382
UMLS CUI [1,1]
C1518384
UMLS CUI [1,2]
C0087111
Other, specify (off treatment reason)
Description

Off treatment reason

Data type

text

Alias
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0566251
LAST DATE OF PROTOCOL TREATMENT
Description

Treatment End Date

Data type

date

Measurement units
  • M D Y
Alias
UMLS CUI [1]
C1531784
M D Y
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS CUI [1]
C0947611
Completed By
Description

Completed By

Data type

text

Alias
UMLS CUI [1]
C1550483
Date Completed
Description

Form Original Complete Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C19464
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI [1]
C1549507
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Similar models

INSTRUCTIONS: Complete and submit this 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. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Data Management Center. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Off Treatment Notice
C1518544 (UMLS CUI-1)
CALGB Form
Item
CALGB Form
text
C0376315 (UMLS CUI [1,1])
C1516238 (UMLS CUI [1,2])
CALGB Protocol Number
Item
CALGB Study No
text
C1516238 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
CALGB Patient ID
Item
CALGB Patient ID
text
C2348585 (UMLS CUI [1,1])
C1516238 (UMLS CUI [1,2])
Amended Data
Item
Amended data?
boolean
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C1511726 (UMLS CUI [1,1])
C1691222 (UMLS CUI [1,2])
Patient's Name
Item
Patient's Name
text
C1299487 (UMLS CUI [1])
Participating Group Name
Item
Participating Group
text
C2347449 (UMLS CUI [1])
Hospital Number
Item
Patient Hospital Number
text
C0806432 (UMLS CUI [1])
Participating Group Protocol Number
Item
Participating Group Protocol No
float
C3274381 (UMLS CUI [1,1])
C2347449 (UMLS CUI [1,2])
Main Member Institution/Affiliate
Item
Main Member Institution/Adjunct
text
C1301943 (UMLS CUI [1])
Participating Group Patient ID
Item
Participating Group Patient No
text
C2348585 (UMLS CUI [1,1])
C2347449 (UMLS CUI [1,2])
Item
REASON OFF TREATMENT
text
C1518544 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
CL.2
Code List
REASON OFF TREATMENT
CL Item
Adverse event (Adverse event)
C0877248 (UMLS CUI-1)
(Comment:en)
CL Item
Patient refused further protocol treatment, but consented to be followed. (Patient refused further protocol treatment, but consented to be followed.)
C3845227 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
(Comment:en)
CL Item
Patient refused further protocol treatment, withdrew consent to be followed. Patient is lost to follow-up. (Patient refused further protocol treatment, withdrew consent to be followed. Patient is lost to follow-up.)
C3845227 (UMLS CUI-1)
C0420315 (UMLS CUI-2)
(Comment:en)
CL Item
Treatment never started (Treatment never started)
C0087111 (UMLS CUI-1)
C1444646 (UMLS CUI-2)
(Comment:en)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy.)
C2825032 (UMLS CUI-1)
(Comment:en)
CL Item
Other, Specify (Other, specify)
C3845569 (UMLS CUI-1)
(Comment:en)
CL Item
Treatment completed per protocol (Treatment completed per protocol)
C0580352 (UMLS CUI-1)
(Comment:en)
CL Item
Patient had disease progression or relapse during active treatment. (Disease progression or relapse)
C1335499 (UMLS CUI-1)
C0277556 (UMLS CUI-2)
(Comment:en)
CL Item
Patient did not respond to therapy (Non-responder)
C0919875 (UMLS CUI-1)
(Comment:en)
CL Item
Patient died during treatment (Patient died)
C1306577 (UMLS CUI-1)
(Comment:en)
CL Item
Patient developed other disease (other disease)
C2359476 (UMLS CUI-1)
(Comment:en)
CL Item
Patient taken off of protocol treatment to receive non-protocol therapy during active protocol treatment. (Non-protocol therapy)
C1518384 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
(Comment:en)
other disease
Item
Patient developed other disease. Specify
text
C2359476 (UMLS CUI [1])
Reason treatment not started
Item
Reason why treatment was not started
text
C3539764 (UMLS CUI [1])
Non-Protocol Therapy
Item
Specify type of non-protocol treatment:
text
C25590 (NCI Thesaurus ObjectClass)
C2167 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1518384 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Off treatment reason
Item
Other, specify (off treatment reason)
text
C1518544 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Treatment End Date
Item
LAST DATE OF PROTOCOL TREATMENT
date
C1531784 (UMLS CUI [1])
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI [1])
Completed By
Item
Completed By
text
C1550483 (UMLS CUI [1])
Form Original Complete Date
Item
Date Completed
date
C19464 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C1549507 (UMLS CUI [1])
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