Disposition

Reported Term for the Disposition Event
SUBJECT REQUESTED TO BE UNBLINDED AS SHE IS SCHEDULED TO RECEIVE EUA COVID-19 VACCINE THROUGH HER WORK. PI UNBLINDED AND SUBJECT WAS WITHDRAWN FROM STUDY.
PT RECEIVED PFIZER COVID-19 VACCINE UNDER EUA, OUTSIDE OF STUDY. WITHDRAWN, PER SPONSOR INSTRUCTIONS.
SUBJECT BEGAN TAKING HYDROXYCHLOROQUINE FOR COVID-19 PREVENTION. IMMUNOSUPPRESSANT DRUGS ARE EXCLUSIONARY FOR THIS STUDY. SUBJECT HAS BEEN WITHDRAWN.
SUBJECT RECEIVED COVID-19 VACCINE UNDER EUA, OUTSIDE OF THE STUDY. WITHDRAWN PER SPONSOR INSTRUCTION.
SUBJECT MOVED OUT OF STATE. PER PI, UNABLE TO PROPERLY FOLLOW COMPLIANCE REQUIREMENTS.
PT RECEIVED J & J COVID 19 VACCINE OUTSIDE OF STUDY ON 03/06/2021
SUBJECT IS UNABLE TO PARTICIPATE IN DECISION VISIT
EUA COVID-19 VACCINE "REQUEST TO UNBLIND"
REQUEST TO UNBLIND/ EUA COVID-19 VACCINE
SUBJECT RECEIVING VACCINE OUTSIDE OF THE STUDY (EUA)
FALSE POSITIVE COVID RESULT REPORTED FROM CENTRAL LAB
REQUEST TO UNBLIND / EUA COVID-19 VACCINE
VACCINATION OUTSIDE OF THE STUDY AND PROTOCOL DEVIATION
SUBJECT RECEIVED A COVID VACCINE THROUGH THEIR WORKPLACE.
SUBJECT RECIEVED A VACCINATION FROM THEIR PLACE FO WORK
FALSE POSITIVE COVID INFECTION RESULTED BY CENTRAL LAB
PATIENT WITHDREW FROM STUDY- DID NOT WANT TO PROCEED.
DID NOT WANT TO PROCEED- PATIENT WITHDREW FROM STUDY
WILL RECEIVE VACCINE AT HER JOB ON 01/19/2021
SUBJECT WAS SCREENED AS A SENTINEL SUBJECT AND VISIT WINDOW CLOSED BEFORE DAY 1 VISIT. SUBJECT IS A SF AND WILL BE RESCREENED WHEN COHORT 2 OPENS AGAIN.
SCREENING VISIT AND DAY 1 WERE OUTSIDE VISIT WINDOW. SUBJECT IS A SF AND WILL BE RESCREENED.
SUBJECT WAS SCREENED AS A SENTIEL SUBJECT. SENTINEL GROUP CLOSED PRIOR TO DAY 1 VISIT. SUBJECT WINDOW WAS UP BEFORE COHORT 2 OPENED. SUBJECT NOTED AS A SF AND WILL BE RE-SCREENED.
SUBJECT RECEIVED COVID VACCINE THROUGH OUTSIDE VENDOR WHILE PARTICIPATING IN THE TRIAL
PATIENT UNBLINDED, DISENROLLED DUE TO PATIENT DESIRE TO RECEIVE OUTSIDE VACCINE OF ANOTHER MANUFACTURER.
PER CRA, POSITIVE COVID SWAB WAS REPORTED IN ERROR BY PPD LABS. PATIENT IS NO LONGER WITHIN WINDOW TO RECEIVE 2ND DOSE.
DR. WILLIAMS DOES NOT FEEL THAT SUBJECT SHOULD RECEIVE ANOTHER DOSE OF STUDY VACCINE DUE TO SAES. DR. WILLIAMS DETERMINED IT WAS IN THE SUBJECT'S BEST INTEREST TO NO LONGER PARTICIPATE.