Please submit this form if the subject has (at least one of the following): 1) completed the post treatment follow-up period per protocol 2) been lost to follow-up 3) has refused follow-up 4) withdrew consent 5) has died. (Note: If all follow-up for a subject has been completed, all subjects (except those never initiating protocol therapy) must have both an Off Protocol Treatment Summary form and Off Study Summary form submitted.)

Off-Study Summary
Description

Off-Study Summary

Alias
UMLS CUI-1
C1518546
UMLS CUI-2
C1706244
Off Study Date
Description

Off-Treatment Study Follow-Up Date

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25601
NCI Thesaurus ObjectClass-2
C15206
NCI Thesaurus Property
C25275
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0011008
mm/dd/yyyy
Off Study Reason (select the primary reason)
Description

Off Study Reason

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25638
NCI Thesaurus Property
C16033
NCI Thesaurus ObjectClass
C25601
NCI Thesaurus ObjectClass-2
C15206
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0566251
Other, specify
Description

Off-Treatment Follow-Up

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus Property
C16033
NCI Thesaurus ObjectClass
C25601
NCI Thesaurus ObjectClass-2
C15206
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C1521902
Comments
Description

Research Comments

Data type

text

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

Similar models

Please submit this form if the subject has (at least one of the following): 1) completed the post treatment follow-up period per protocol 2) been lost to follow-up 3) has refused follow-up 4) withdrew consent 5) has died. (Note: If all follow-up for a subject has been completed, all subjects (except those never initiating protocol therapy) must have both an Off Protocol Treatment Summary form and Off Study Summary form submitted.)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Off-Study Summary
C1518546 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
Off-Treatment Study Follow-Up Date
Item
Off Study Date
date
C25164 (NCI Thesaurus ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C25275 (NCI Thesaurus Property)
C1518544 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Off Study Reason (select the primary reason)
integer
C25638 (NCI Thesaurus ValueDomain)
C16033 (NCI Thesaurus Property)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C1518544 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Off Study Reason (select the primary reason)
CL Item
Protocol-defined Follow-up Completed (1)
C1522577 (UMLS CUI-1)
C0205197 (UMLS CUI-2)
CL Item
Patient lost to follow-up (2)
C2348579 (UMLS CUI-1)
CL Item
Patient refused follow-up (3)
C0580699 (UMLS CUI-1)
CL Item
Death (4)
C0011065 (UMLS CUI-1)
CL Item
Adverse Event/Side Effects/Complications (5)
C0877248 (UMLS CUI-1)
CL Item
Other (6)
C0205394 (UMLS CUI-1)
Off-Treatment Follow-Up
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C16033 (NCI Thesaurus Property)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C1518544 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI [1])