HIV Cidovir High-Grade Squamous Intraepithelial Lesions NCT00550589 AMC-046
AMC-046 Off-Study Summary Form (F50) Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus https://clinicaltrials.gov/ct2/show/NCT00550589

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
Ccrr Module For Off Study Summary - Rf50
C1518546 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
Off-Study Follow-Up End 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])
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)
C2985814 (UMLS CUI [1])
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-Study Follow-Up
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C16033 (NCI Thesaurus Property)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
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])