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-061 Off Study Summary Form (F50)
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Off-TreatmentStudyFollow-UpEndDate
Item
Off Study Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Off Study Reason (select the primary reason)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C0392360 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
CL Item
Protocol-defined Follow-up Completed (Protocol-defined follow-up completed)
CL Item
Lost To Follow-up (Patient lost to follow-up)
CL310949 (NCI Metathesaurus)
CL Item
Patient Refused Follow-up (Patient refused follow-up)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
C0011065 (UMLS 2011AA)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C0205394 (UMLS 2011AA)
Off-TreatmentStudyFollow-UpSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C1521902 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)