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.

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])
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial