Information:
Error:
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.)
- StudyEvent: AMC-045 Off Study Summary Form (F50)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Off Study Date
Item
Off Study Date
date
C25164 (NCI Thesaurus ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2985813 (UMLS CUI [1])
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2985813 (UMLS CUI [1])
Item
Off Study Reason (select the primary reason)
text
C25638 (NCI Thesaurus ValueDomain)
C16033 (NCI Thesaurus Property)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C2985814 (UMLS CUI [1,1])
C16033 (NCI Thesaurus Property)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C2985814 (UMLS CUI [1,1])
CL Item
Protocol-defined Follow-up Completed (Protocol-defined follow-up completed)
C1522577 (UMLS CUI-1)
C0205197 (UMLS CUI-2)
C0205197 (UMLS CUI-2)
CL Item
Lost To Follow-up (Patient lost to follow-up)
CL310949 (NCI Metathesaurus)
C1302313 (UMLS CUI-1)
C1302313 (UMLS CUI-1)
CL Item
Patient Refused Follow-up (Patient refused follow-up)
C0580699 (UMLS CUI-1)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS CUI-1)
C0011065 (UMLS CUI-1)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
C0877248 (UMLS CUI-1)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS CUI-1)
C0205394 (UMLS CUI-1)
Off Treatment Reason
Item
Off-Treatment Study Follow-Up Specify
text
C25685 (NCI Thesaurus ValueDomain)
C16033 (NCI Thesaurus Property)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C2985814 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C16033 (NCI Thesaurus Property)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C2985814 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Comments
Item
Research Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI [1])
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI [1])