Document text
16.2.1.1 Listing of Subjects Withdrawn From the Study – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Randomized) Subject Dose
No. Rel
Daya Withdrawal
Date Study
Phase Withdrawal
Reason Commentb
No subject meets the
reporting criteria.
a. Relative Day (Rel Day) = date of withdrawal - date of last vaccination + 1. For a withdrawal that occurred before the date of the first study
vaccination, +1 was not added to compute relative day.
b. MedDRA (v23.0) coding dictionary applied.
PFIZER CO NFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adds Table Generation: 29AUG2020 (08:38)
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: (CDISC)/C4591001 IA P1/adds l001 p1
090177e194d7854e\Final\Final On: 07-Sep-2020 03:52 (GMT)
Page 1
FDA-CBER-2021-5683-0128990
16.2.1.1.1 Listing of Subjects Withdrawn From the Study Before Dose 2 – Phase 1 – BNT162b1 (100 μg )
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Randomized) Subject Dose
No. Rel
Daya Withdrawal
Date Study
Phase Withdrawal
Reason Commentb
No subject meets the
reporting criteria.
a. Relative Day (Rel Day) = date of withdrawal - date of last vaccination + 1. For a withdrawal that occurred before the date of the first study
vaccination, +1 was not added to compute relative day.
b. MedDRA (v23.0) coding dictionary applied.
PFIZER CO NFIDENTIAL SDTM Creation: 28AUG2020 (16:27) Source Data: adds Table Generation: 19SEP2020 (10:19)
(Cutoff Date: 24AUG2020, Snapshot Date: 28AUG2020) Output File: ./nda3/C4591001 IA P1 100/adds l001 100 p1
090177e194fbc02f\Final\Final On: 22-Sep-2020 14:25 (GMT)
Page 2
FDA-CBER-2021-5683-0128991
16.2.1.2 Listing of Subjects Withdrawn From the Study – Phase 2
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal
Reason Commentb
18-55 C4591001 1079
10791004 1 23 20AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/ADENOCARCINOMA
GASTRIC
1 30 27AUG2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
a. Relative Day (Rel Day) = date of withdrawal - date of last vaccination + 1. For a withdrawal that occurred before the date of the first study vaccination, +
1 was not added to compute relative day.
b. MedDRA (v23.0) coding dictionary applied.
PFIZER C ONFIDENTIAL SDTM Creation: 05SEP2020 (14:11) Source Data: adds Table Generation: 09SEP2020 (23:17)
(Cutoff Date: 02SEP2020, Snapshot Date: 04SEP2020) Output File: ./nda2 unblinded/C4591001 IA P2/adds l001 withdraw p2
090177e194e7a3aa\Final\Final On: 14-Sep-2020 01:45 (GMT)
Page 3
FDA-CBER-2021-5683-0128992
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
16-55 C4591001
1001
10011125 1 37 09SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Withdrew consent and decided not to continue in study.
1 37 09SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient withdrew consent
C4591001
1003
10031140
04AUG2020 FOLLOW -UP PROTOCOL
DEVIATION Randomized in error.
C4591001
1003
10031143
04AUG2020 FOLLOW -UP PROTOCOL
DEVIATION Randomized in error.
C4591001
1005
10051308 1 1 19OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT busy work schedule
1 1 19OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT busy work schedule
C4591001
1005
10051341 1 2 22OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject tested COVID positive between visits 1 and 2
C4591001
1005
10051381
28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject decided to withdraw consent after randomized in
IVRS but before given vaccine
C4591001
1007
10071179 2 29 01OCT2020 VACCINATION LOST TO FOLLOW -UP phone attempt 01oct2020, 02oct2020, 05oct2020; certified
letter 05o ct2020
2 29 01OCT2020 FOLLOW -UP LOST TO FOLLOW -UP phone attempt 01oct2020, 02oct2020,05oct2020; certified
letter 05oct2020
C4591001
1007
10071407 1 15 05NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion # 5; Subject has diagnosis of COVID -19 with
positive PCR and symptoms
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 4
FDA-CBER-2021-5683-0128993
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1008
10081529 1 5 29SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject tested positive for COVID19
C4591001
1008
10081721 1 13 10NOV2020 VACCINATIO N NO LONGER MEETS
ELIGIBILITY CRITERIA subject tested positive for COVID 19
C4591001
1009
10091211 1 19 03NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject tested positive for COVID -19
C4591001
1009
10091257 1 10 05NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA positive for COVID -19
C4591001
1012
10121001 1 26 28AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject refused second vaccination; will continue in study
for follow -up.
C4591001
1012
10121103 2 2 23SEP2020 VACCINATION MEDICATION ERROR
WITHOUT
ASSOCIATED
ADVERSE EVENT MEDICATION ERROR WITHOUT ASSOCIATED
ADVERSE EVENT
2 2 23SEP2020 FOLLOW -UP MEDICATION ERROR
WITHOUT
ASSOCIATED
ADVERSE EVENT MEDICATION ERROR WITHOUT ASSOCIATED
ADVERSE EVENT
C4591001
1012
10121163 1 16 24SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/INJECTION SITE DERMATITIS
1 39 17OCT2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
C4591001
1013
10131017
30JUL2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT FROM STUDY.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 5
FDA-CBER-2021-5683-0128994
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1013
10131046 2 70 27OCT2020 VACCINATION LOST TO FOLLOW -UP subject is lost to follow up. certified letter sent and emailed
10-02-2020
2 70 27OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT IS LOST TO FOLLOW UP.
C4591001
1013
10131048 2 28 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT New job
2 28 17SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT New Job
C4591001
1013
10131054 2 7 30AUG2020 VACCINATION LOST TO FOLLOW -UP Attempted contact
2 7 30AUG2020 FOLLOW -UP LOST TO FOLLOW -UP Contact attempted
C4591001
1013
10131131 2 36 07OCT2020 VACCINATION LOST TO FOLLOW -UP Certified letter sent
2 36 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent
C4591001
1013
10131138 1 23 02SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT FROM THE STUDY
1 23 02SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT.
C4591001
1013
10131216 1 46 02OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew from study
1 46 02OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT DUE TO FAMILY
SITUATION.
C4591001
1013
10131332 2 56 09NOV2020 VACCINATION LOST TO FOLLOW -UP UNKOWN
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 6
FDA-CBER-2021-5683-0128995
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 56 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP UNKNOWN
C4591001
1013
10131426 1 1 03SEP2020 VACCINATION LOST TO FOLLOW -UP subject has not returned for next visit. is now considered
lost to follow up
1 1 03SEP2020 FOLLOW -UP LOST TO FOLLOW -UP subject is lost to follow up.
C4591001
1013
10131592 2 31 11NO V2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent from study.
2 31 11NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT MOVED OUT OF STATE NO LONGER WANTED TO
PARTICIPATE.
C4591001
1013
10131670† 1 4 11OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA SUBJECT TESTED POSITIVE FOR COVID -19
C4591001
1013
10131740
15OCT2020 FOLLOW -UP OTHER randomized in error, needed to wait until course of
antibiotics was done.
C4591001
1013
10131746 1 22 09NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Currently taking corticosteroids
1 22 09NOV2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY C RITERIA Currently taking exclusionary medication
C4591001
1015
10151030 2 64 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject lost to follow up after multiple contact attempts and
reciept of certified letter
2 64 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up after multiple contact attempts and
reciept of certified letter
C4591001
1015
10151134 1 72 06NOV2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/VERTIGO
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0128996
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1015
10151199 1 24 01OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject decided not to continue with study.
1 24 01OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent.
C4591001
1016
10161047 1 24 27AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject stated at visit 2, had positive COVID test
C4591001
1016
10161087 1 22 31AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/INJECTION SITE SWELLING
C4591001
1016
10161126 1 39 21SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject declined further study vaccines,subject will
continue with rest of visits and procedures
C4591001
1016
10161341 1 10 31OCT2020 VACCI NATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject with a positive covid -19 test
C4591001
1018
10181025 1 45 16SEP2020 VACCINATION LOST TO FOLLOW -UP Follow -up attempts made on 21 -Aug, 1 -Sep, and 4 -Sep
with no response.
1 45 16SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Follow -up attempts made on 21 -Aug, 1 -Sep, and 4 -Sep.
Certified letter sent 9 -Sep-2020.
C4591001
1018
10181036 1 45 16SEP2020 VACCINATION LOST TO FOLLOW -UP Subject missed V2 and did not respond to 3 Follow -up
attempts.
1 45 16SEP2020 FOLLOW -UP LOST TO FOLLOW -UP no response to multiple follow up calls and contact
attempts
C4591001
1018
10181054 1 39 11SEP2020 VACCINATION LOST TO FOLLOW -UP patient returned to home country, did not respond to
outreach, certified letter sent
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 8
FDA-CBER-2021-5683-0128997
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 39 11SEP2020 FOLLOW -UP LOST TO FOLLOW -UP subject returned to home country, according to call to
emergency contact
C4591001
1018
10181142 1 33 14SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject did not arrive at scheduled second visit and texted
no longer wants to participate in study.
1 33 14SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject did not arrive at scheduled second visit and texted
no longer wants to participate in study.
C4591001
1018
10181266 1 41 14OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT withdraw from study due to work schedule
1 41 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdraw from study due to work schedule
C4591001
1019
10191098 1 18 11SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Pt discontinued due to positive covid test. Will f/u with pt
C4591001
1019
10191166 1 22 25SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent.
1 22 25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent.
C4591001
1027
10271105 1 15 11SEP2020 VACCINATION ADVERSE EVENT Subject has discontinued Study Drug. Subject has agreed to
continue with follow -up visits./ALLERGY TO VACCINE
C4591001
1028
10281072 1 55 20OCT2020 VACCINATION LOST TO FOLLOW -UP certified letter returned unclaimed 20oct2020
1 55 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter came back unclaimed on 20Oct2020
C4591001
1028
10281294 1 7 04NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA patient had positive covid test prior to V2
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 9
FDA-CBER-2021-5683-0128998
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1036
10361011 1 1 20AUG2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up
1 1 20AUG2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1036
10361032 2 48 03NOV2020 VACCINATION LOST TO FOLLOW -UP unreachable
2 48 03NOV2020 FOLLOW -UP LOST TO FOLLOW -UP unreachable
C4591001
1036
10361050
31AUG2020 FOLLOW -UP OTHER Subject randomized in error due to prohibitive drug.
C4591001
1037
10371068 1 3 27AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA SUBJECT MET EXCL CRIT # 13
C4591001
1037
10371077 1 66 30OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT SPOKE WITH SUBJECT ON 30 OCT. DUE TO
SCHEDULE, HE CAN NO LONGER CONTINUE WITH
STUDY VISITS
1 66 30OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SPOKE WITH SUBJECT ON 30 OCT. DUE TO
SCHEDULE, HE CAN NO LONGER ATTEND VISITS
C4591001
1037
10371078 1 44 08OCT2020 VACCINATION LOST TO FOLLOW -UP SITE ATTEMPTED CONTACT ON 22 SEP 30 SEP AND
CERTIFIED LETTER SENT 8 OCT NO RESPONSE
1 44 08OCT2020 FOL LOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 8 ONT. PT DID NOT
RESPOND
C4591001
1039
10391021 1 24 17SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Patient tested positive for COVID -19.
C4591001
1039
10391080 1 21 23SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Patient withdrew consent. Patient will not be participating
in follow -ups.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 10
FDA-CBER-2021-5683-0128999
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 21 23SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient withdrew from study and follow up.
C4591001
1042
10421069 1 22 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
1 22 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1042
10421079 2 55 02NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to follow -up after unsuccessful attempts to contact
2 55 02NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up after unsuccessful attempts to make
contact.
C4591001
1042
10421092 2 27 06OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject called the office in withdrew consent -they will not
be returning to the site for future visi
2 27 06OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew from study participation
C4591001
1042
10421093 2 48 19OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up after unsuccessful attempts to make
contact.
2 48 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up after unsuccessful attempts to make
contact.
C4591001
1042
10421129 2 41 19OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up after unsuccessful attempts to make
contact.
2 41 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up after unsuccessful attempts to make
contact.
C4591001
1042
10421250 1 58 13NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up
1 58 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 11
FDA-CBER-2021-5683-0129000
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1042
10421251 1 58 13NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up
1 58 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1046
10461040 1 15 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject chose to discontinue due to personal reasons.
1 15 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Decision
C4591001
1046
10461049 2 31 09OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject Withdrew
2 31 09OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject decision
C4591001
1046
10461099 1 64 27OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject Decision
1 64 27OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Decision
C4591001
1046
10461140 1 22 19SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject Decision
1 22 19SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Decision
C4591001
1047
10471221 1 44 29OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent
1 44 29OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 12
FDA-CBER-2021-5683-0129001
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1047
10471314 1 32 12NOV2020 VACCINATION LOST TO FOLLOW -UP Subject is lost to follow up
C4591001
1052
10521021 2 63 11NOV2020 VACCINATION LOST TO FOLLOW -UP lost to follow up
2 63 11NOV2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1052
10521022 2 63 11NOV2020 VACCINATION LOST TO FOLLOW -UP lost to follow up
2 63 11NOV2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1052
10521054 1 25 21SEP2020 VACCINATION LOST TO FOLLOW -UP n/a
1 25 21SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1052
10521057 1 25 21SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent
1 25 21SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrawal by subject
C4591001
1052
10521058 1 25 21SEP2020 VACCINATION LOST TO FOLLOW -UP lost to follow up
1 25 21SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1052
10521064 1 25 24SEP2020 VACCINATION LOST TO FOLLOW -UP n/a
1 25 24SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost of follow up
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0129002
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1052
10521080 1 28 29SEP2020 VACCINATION LOST TO FOLLOW -UP lost of follow up
1 28 29SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost of follow up
C4591001
1054
10541022 1 64 23OCT2020 VACCINATION LOST TO FOLLOW -UP Pt deemed LTFU by site.
1 64 23OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Pt deemed LTFU by site.
C4591001
1054
10541023 1 64 23OCT2020 VACCINATION LOST TO FOLLOW -UP Pt deemed LTFU by site.
1 64 23OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Pt deemed LTFU by site.
C4591001
1054
10541033 1 21 11SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Per sponsor, participant met EXC #5, and should not
receive VAX2 but may remain in study.
C4591001
1054
10541055 1 59 23OCT2020 VACCINATION LOST TO FOLLOW -UP Pt deemed LTFU by site.
1 59 23OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Pt deemed LTFU by site.
C4591001
1054
10541064 1 78 12NOV2020 VACCINATION LOST TO FOLLOW -UP > 3 attempts at contacting pt via telephone; certified letter
sent
1 78 12NOV2020 FOLLOW -UP LOST TO FOLLOW -UP > 3 attempts at contacting pt via telephone; certified letter
sent
C4591001
1054
10541138 1 23 02OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject doesn't want to continue in study.
1 23 02OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject doesn't want to continue in study.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 14
FDA-CBER-2021-5683-0129003
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1054
10541150 1 22 05OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT No longer interested in study, and walked out of clinic w/o
talking to Investigator.
1 22 05OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt is no longer interested in study. Walked out of clinic w/o
seeing the Investigator.
C4591001
1055
10551145 1 48 14OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DYSPHAGIA
C4591001
1056
10561027 1 35 25SEP2020 VACCINATION LOST TO FOLLOW -UP Subject couldn't be reached. Caregiver states he left the
house and nobody knows where he is.
1 35 25SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject couldn't be reached. Caregiver states he left the
house and nobody knows where he is.
C4591001
1056
10561129 1 24 25SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject states he doesn't want to continue in the study
1 24 25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject states he doesn't want to continue in the study
C4591001
1056
10561152 1 27 29SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT STATED HE DOES NOT WANT TO
CONTINUE HIS PARTICIPATION IN THE STUDY.
1 27 29SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT STATED HE DOES NOT WANT TO
CONTINUE HIS PARTICIPATION IN THE STUDY.
C4591001
1056
10561253 2 32 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT MOVED OUT OF STATE AND HE IS
UNABLE TO CONTINUE PARTICIPATING IN THE
STUDY.
2 32 05NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT MOVED OUT OF STATE AND HE IS
UNABLE TO CONTINUE PARTICIPATING IN THE
STUDY.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 15
FDA-CBER-2021-5683-0129004
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1056
10561293 1 50 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
1 50 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
C4591001
1056
10561372 1 38 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
1 38 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
C4591001
1056
10561395 1 25 29OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT MOVED TO ANOTHER TOWN
1 25 29OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject moved out of town .
C4591001
1057
10571031
18AUG2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA met delay criteria, reported by subject after subject was
randomized, discontinued prior to vaccine
C4591001
1057
10571211
18SEP2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA subject was randomized but failed to meet entry criteria, no
vaccine wa s given
C4591001
1057
10571212
18SEP2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA subject was randomized and then failed to meet criteria, no
vaccine was administered
C4591001
1057
10571215
18SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT refused further study procedures
C4591001
1057
10571216 2 30 10NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT MOVED TO SAN FRANCISCO
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 16
FDA-CBER-2021-5683-0129005
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 30 10NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT MOVED TO SAN FRANCISCO
C4591001
1057
10571248 1 36 30OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject refused to return for Visit 2, withdrew consent, No
adverse events reported
1 36 30OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent from further study participation
C4591001
1057
10571268
06OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT w/d consent
C4591001
1066
10661335
14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent to participate
C4591001
1071
10711095 1 61 24OCT2020 VACCINATION LOST TO FOLLOW -UP SUBJECT IS LOST TO FOLLOW UP
1 61 24OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT IS LOST TO FOLLOW UP
C4591001
1071
10711162
11SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT During discussing the diary, the subject withdrew consent
and subject left.
11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1071
10711211 1 32 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT TO 2ND
INJECTION BUT WILL RETURN FOR FOLLOW UP
VST
C4591001
1072
10721051 1 12 06SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA diagnosis COVID -19 exclusion 5
C4591001
1073
10731038 1 37 10SEP2020 VACCINATION LOST TO FOLLOW -UP Subject was Discontinue
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 17
FDA-CBER-2021-5683-0129006
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 37 10SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Discontinue
C4591001
1079
10791004 1 23 20AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/ADENOCARCINOMA GASTRIC
1 30 27AUG2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
C4591001
1079
10791040 2 45 07OCT2020 VACCINATION LOST TO FOLLOW -UP Subject has not returned calls, emails or letters
2 45 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject is lost to follow up
C4591001
1079
10791130 1 1 17AUG2020 VACCINATION MEDICATION ERROR
WITHOUT
ASSOCIATED
ADVERSE EVENT MEDICATION ERROR WITHOUT ASSOCIATED
ADVERSE EVENT
C4591001
1079
10791253 1 67 13NOV2020 VACCINATION LOST TO FOLLOW -UP patient unresponsive
C4591001
1081
10811071 1 48 05OCT2020 VACCINATION LOST TO FOLLOW -UP lack of follow -up, does not return calls & had multiple no
show appointments
1 48 05OCT2020 FOLLOW -UP LOST TO FOLLOW -UP unable to reach subj, multiple no -show appts. This was the
last scheduled visit that was a no -show.
C4591001
1081
10811105
26AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1081
10811194 2 34 01NOV2020 FOLLOW -UP DEATH DEATH
C4591001
1082
10821013
03AUG2020 FOLLOW -UP PROTOCOL
DEVIATION Subject was randomized but left site prior to receiving
vaccination.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 18
FDA-CBER-2021-5683-0129007
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1082
10821077 1 22 28AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT scheduling conflicts. live out of state .
1 22 28AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1082
10821078 1 22 28AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT scheduling conflicts. live out of state.
1 22 28AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1082
10821145 2 30 23OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent due to occupation
2 30 23OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent due to occupation
C4591001
1083
10831029 1 20 23AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/ATRIAL FIBRILLATION
C4591001
1083
10831060 1 9 14AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DIVERTICULAR PERFORATION
C4591001
1083
10831141 1 34 23SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject no longers wants to participate in the study subject
was offered safety F/U Sub Declined
1 34 23SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject decision Subject no longers wants to participate in
the study subject was offered safety F/U
C4591001
1083
10831187 2 28 22OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT MOVE OUT OF STATE
2 28 22OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT 22OCT2020 subject was contacted for V3 Appointment
reminder 23OCT2020 and verbally withdrew consent
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 19
FDA-CBER-2021-5683-0129008
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1083
10831219 2 37 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject was contacted to reschedule Visit 3 and he
withdrew consent
2 37 05NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT 05NOV2020 After mulitple attempts to contact subj to
reschedule V3 subj returned call and WC
C4591001
1084
10841035 1 22 24AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT subject does not want to do study anymore; now engaged
and wants to start a family
1 22 24AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent because subject wants to start a family
C4591001
1084
10841057 1 35 08SEP2020 VACCINATION LOST TO FOLLOW -UP subject never answered phone calls; certified letter sent
1 35 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP subject never answered phone calls; certified letter sent
C4591001
1084
10841119 2 38 07OCT2020 VACCINATION LOST TO FOLLOW -UP certified letter sent
2 38 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject LTFU; certified letter sent
C4591001
1084
10841272 1 32 22SEP2020 VACCINATION LOST TO FOLLOW -UP LTFU
1 32 22SEP2020 FOLLOW -UP LOST TO FOLLOW -UP LTFU
C4591001
1085
10851286 1 34 12OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Positive COVID -19 test result prior to vaccination 2 as
such subject meets exclusion criteria.
1 58 05NOV2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Positive Covid test prior to vaccine 2
C4591001
1087
10871085 2 13 20SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Pt moved to another State for job. Closest Site 1+ hr away
from pt's new location. Withdrew consent.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 20
FDA-CBER-2021-5683-0129009
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 13 20SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt moved to another State for job. Closest Site 1+ hr away
from pt's new location. Withdrew consent.
C4591001
1087
10871089 1 19 04SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criteria #5
C4591001
1087
10871209 1 7 31AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject has met exclusion #5
1 38 01OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject chose to withdraw from study because felt no
longer necessary due to positive COVID dx.
C4591001
1087
10871336 1 61 02NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up
1 61 02NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1087
10871354 1 10 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject does not feel comfortable continuing in the study .
Withdrawal of participation and consent.
1 10 17SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject does not feel comfortable continuing in study.
Withdrawal of participation & consent.
C4591001
1087
10871356 1 54 31OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up.
1 54 31OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up.
C4591001
1087
10871557 1 23 05NOV2020 VACCINATION PREGNANCY PREGNANCY
C4591001
1089
10891076 1 22 27AUG2020 VACCINATION LOST TO FOLLOW -UP 8/25-# out of service, sent email 8/27 -no response, sent
certified letter
1 22 27AUG2020 FOLLOW -UP LOST TO FOLLOW -UP number invaild and sent certified letter. no response
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 21
FDA-CBER-2021-5683-0129010
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1089
10891158 1 44 02OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA site was notified that subject has been incarcerated and will
not be able to complete study vi sit
1 44 02OCT2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA site was notified that subject has been incarcerated and will
not be able to complete study visit
C4591001
1089
10891346
22SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent prior to receiving vaccine
C4591001
1089
10891351
25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent, and left office prior to
vaccination
C4591001
1090
10901047 2 45 07OCT2020 VACCINAT ION LOST TO FOLLOW -UP Pt was not reachable the last 2 weeks. HE is in prison per
his sister. Pt will be discontinued.
2 45 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP pt in prison
C4591001
1090
10901068 1 29 02SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT pt is not willing to come to any m visits
1 29 02SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject no longer interested in study
C4591001
1090
10901379 1 54 02NOV2020 VACCINATION LOST TO FOLLOW -UP pt never contacted us to reschedule V2
1 54 02NOV2020 FOLLOW -UP LOST TO FOLLOW -UP unable to contact
C4591001
1090
10901507 1 20 04NOV2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/URTICARIA
C4591001
1091
10911039 1 50 22SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent to future visits
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 22
FDA-CBER-2021-5683-0129011
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 50 22SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrew consent to further visits
C4591001
1091
10911077 1 22 27AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Patient agrees to stay in the trial for follow up but denied
second vaccination.
C4591001
1091
10911083 1 23 28AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Did not want to come to scheduled visits
1 23 28AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject no longer wanted to come to study appointments
C4591001
1091
10911352 1 23 28OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject was a NCNS for his V2 today. Stated over the
phone he would like to withdraw consent
1 23 28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject was a NCNS for his V2. Stated over the phone he
would like to withdraw consent
C4591001
1091
1091138 7 1 5 09NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA NO LONGER MEETS ELIGIBILITY CRITERIA
C4591001
1092
10921080 1 22 16SEP2020 VACCINATION OTHER Incarcerated 09Sep2020
1 22 16SEP2020 FOLLOW -UP OTHER Incarcerated
C4591001
1092
10921082 2 35 20OCT2020 VACCINATION LOST TO FOLLOW -UP unable to make contact with subject
2 35 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject is Lost to follow up
C4591001
1092
10921128
01SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt withdrew consent due to anxiety of having blood drawn
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 23
FDA-CBER-2021-5683-0129012
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1092
10921130 2 21 12OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA confirmed covid illness
C4591001
1093
10931055
31AUG2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA UNABLE TO OBTAIN BLOOD FROM SUBJECT.
C4591001
1093
10931058 1 25 18SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/EXPOSURE DURING
PREGNANCY
C4591001
1093
10931065 1 81 14NOV2020 VACCINATION LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER AND
WAS UNABLE TO BE CONTACTED MULTIPLE
TIMES.
1 81 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER AND
WAS UNABLE TO BE CONTACTED MULTIPLE
TIMES.
C4591001
1093
1093109 4 1 76 14NOV2020 VACCINATION LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER AFTER
MULTIPLE ATTEMPTS TO CONTACT THEM.
1 76 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER AFTER
MULTIPLE ATTEMPTS TO CONTACT THEM.
C4591001
1095
10951056 1 35 08SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Participant is no longer able to participate
1 37 10SEP2020 FOLLOW -UP OTHER Participant not able to continue in study at this time.
Participant did not withdraw consent
C4591001
1095
10951110 1 71 28OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT completed Vac 1, but declined vac 2 but will participate in
all other study procedures. approved MD
C4591001
1095
10951141 1 22 16SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 24
FDA-CBER-2021-5683-0129013
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 22 16SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/DIABETIC FOOT
C4591001
1095
10951168 1 48 15OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject will not receive vaccination however will
participate in all other study procedures
C4591001
1095
10951173 1 8 05SEP2020 VACCINATION ADVERSE E VENT ADVERSE EVENT/ACUTE MYOCARDIAL
INFARCTION
C4591001
1096
10961031 1 22 04SEP2020 VACCINATION PREGNANCY PREGNANCY
C4591001
1096
10961081 1 54 12OCT2020 VACCINATION LOST TO FOLLOW -UP LTFU, unresponsive to contact attempts
1 54 12OCT2020 FOLLOW -UP LOST TO FOLLOW -UP site unable to contact subject after multiple attempts and
certified letter sent
C4591001
1096
10961141 1 22 16SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA per protocol
C4591001
1096
10961276 1 21 25SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT due to moving out of town unexpectedly
1 21 25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT due to moving out of town unexpectedly
C4591001
1096
10961321 1 22 03OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject met exclusion #1 on visit 2 (suicidal ideation) so no
vaccine was administered
C4591001
1096
10961388 1 21 29OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject was diagnosed with COVID between vaccination
one and vaccination two
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 25
FDA-CBER-2021-5683-0129014
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1098
10981001 1 31 17SEP2020 VACCINATION LOST TO FOLLOW -UP Lost to followup
1 31 17SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter was sent. Site is unable to contact the
subject. Thanks.
C4591001
1098
10981029 1 22 11SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject wanted to be discontinued from the study for
unknown reasons.
1 22 11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject inform, it is due to wellbeing
C4591001
1098
10981200 1 46 05NOV2020 VACCINATION LOST TO FOLLOW -UP Subject called multiple times and certified letter was sent.
No response from subject
1 46 05NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject called multiple times and certified letter was sent.
No response from subject.
C4591001
1098
10981219 1 43 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT withdraw by subject due to no longer wanting to take part
in the study.
1 43 05NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdraw by subject due to no longer wanting to take part
in the study.
C4591001
1101
11011024 1 21 29SEP2020 VACCINATION NO LONG ER MEETS
ELIGIBILITY CRITERIA the subject was diagnoses with COVID between
vaccination one and vaccination two
C4591001
1107
11071074 2 74 12NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT ON 12NOV2020
C4591001
1109
11091030 2 37 23SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT CALLED TO WITHDRAW FROM TRIAL
DUE TO TRANSPORTATION ISSUES AS WELL AS
BEING TO BUSY.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 26
FDA-CBER-2021-5683-0129015
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 37 23SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJEC T SUBJECT CALLED TO WITHDRAW FROM TRIAL
DUE TO TRANSPORTATION ISSUES AS WELL AS
BEING TO BUSY.
C4591001
1109
11091059 1 40 08SEP2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RETURNED PHONE CALLS OR
RESPOND TO CERTIFIED LETTER.
1 40 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RETURNED PHONE CALLS OR
RESPOND TO CERTIFIED LETTER.
C4591001
1109
11091068 1 40 08SEP2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RETURNED NUMEROUS CALLS
OR CERTIFIED LETTER SENT TO HIM.
1 40 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO CALLS OR
CERTIFIED LETTER.
C4591001
1109
11091127 1 37 08SEP2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVE R RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT TO HER
1 37 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVE RESPONDED TO CALLS OR
CERTIFIED LETTER SENT TO HER.
C4591001
1109
11091148 2 33 26SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT CALLED AND WITHDREW CONSENT
2 33 26SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT CALLED AND WITHDREW CONSENT
C4591001
1109
11091234 1 25 08SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT WORK HAD GOTTEN TOO BUSY WITH OPENING
BACK UP AND SHE WAS UNABLE TO CONTINUE
HER PARTICIPATION.
1 25 08SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT WORK HAD GOTTEN TOO BUSY WITH OPENING
BACK UP AND SHE WAS UNABLE TO CONTINUE
HER PARTICIPATION.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 27
FDA-CBER-2021-5683-0129016
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1109
11091335 1 43 07OCT2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT TO HER
1 43 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT TO HER
C4591001
1109
11091349
28AUG2020 FOLLOW -UP PROTOCOL
DEVIATION Subject randomized in error.
C4591001
1109
11091419 2 40 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject did no t respond to multiple phone calls or certified
letter.
2 40 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not respond to multiple phone calls or certified
letter.
C4591001
1109
11091478 1 29 07OCT2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
1 29 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT
C4591001
1109
11091515 1 30 14OCT2020 VACCINATION LOST TO FOLLOW -UP Subject never returned for visit, responded to call or
certified letter sent.
1 30 14OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject never returned for visit, responded to call or
certified letter sent.
C4591001
1109
11091556 1 9 12OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1110
11101006 1 53 21SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject meets exclusion criteria #5
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 28
FDA-CBER-2021-5683-0129017
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1110
11101010 2 63 22OCT2020 VACCINATION LOST T O FOLLOW -UP Subject did not comply with inclusion criteria #2.
2 63 22OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not comply with inclusion criteria #2.
C4591001
1110
11101038 1 35 08SEP2020 VACCINATION LOST TO FOLLOW -UP Subject was contact over the phone 3 times and a certified
letter was sent. Subject never reply.
1 35 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow is status, subject has been withdrawn from
trial.
C4591001
1110
11101039 1 35 08SEP2020 VACCINATION LOST TO FOLLOW -UP subject failed to contact site after many calls and certified
letter.
1 35 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not respond to many phones calls from site and
did not res pond to certified letter fromi
C4591001
1110
11101069 1 59 08OCT2020 VACCINATION LOST TO FOLLOW -UP Subject was called more the 3 times,was texted 2
times,email/certified letter were sent
1 59 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP we did more than 3 attempts via phone, 1 text message, 4
emails and a certified letter.
C4591001
1110
11101085 1 58 08OCT2020 VACCINATION LOST TO FOLLOW -UP Subject was tried to contact by phone, text, email and
certified letter several times.
1 58 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP we did 4 phone call attempts, 1 text message, 1 email and a
certified letter.
C4591001
1110
11101110 1 22 08SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
1 22 08SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 29
FDA-CBER-2021-5683-0129018
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1110
11101141 2 56 12NOV2020 VACCINATION LOST TO FOLLOW -UP 4 attempts via phone call, 1 text message, 1 email and 1
certified letter.
2 56 12NOV2020 FOLLOW -UP LOST TO FOLLOW -UP 4 attempts via phone call, 1 text message, 1 email and 1
certified letter.
C4591001
1110
11101154 1 21 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject was contacted over the phone because she missed
visit 2 and subject withdraw consent.
1 21 17SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent verbally over the phone.
C4591001
1110
11101155 1 21 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject was contacted over the phone because she missed
visit 2 and subject withdraw cons ent.
1 21 17SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject verbally withdrew consent.
C4591001
1110
11101229 1 21 30SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject meets exclusion criterion #5
C4591001
1110
11101247 1 22 06OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject WICF because he is unable to continue with the
visit due to work.
1 22 06OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject WICF because he is unable to continue with the
visit due to work.
C4591001
1110
11101250 1 22 06OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject did not provide a reason to be discontinued from
the study.
1 22 06OCT2020 FOLLOW -UP WITHDRAWA L BY
SUBJECT Subject did not provide a reason to be discontinued from
the study.
C4591001
1110
11101333 1 35 05NOV2020 VACCINATION LOST TO FOLLOW -UP we attempt 3 phone calls, 1 text message and 1 certified
letter.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 30
FDA-CBER-2021-5683-0129019
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 35 05NOV2020 FOLLOW -UP LOST TO FOLLOW -UP we attempt 3 phone calls, 1 text message and 1 certified
letter.
C4591001
1110
11101342 1 31 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject sent and email, he state he will like to withdraw
from the study due to a private reason.
1 31 05NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject sent and email, he state he will like to withdraw
from the study due to a private reason.
C4591001
1111
11111099 1 71 20OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject refused second vaccination but will continue with
follow -up procedures
C4591001
1112
11121054 2 43 07OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT sujbect withdrew consent due to work schedule
2 43 07OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew due to busy work schedule
C4591001
1112
11121058 1 22 25AUG2020 VACCINATION OTHER
1 22 25AUG2020 FOLLOW -UP OTHER
C4591001
1112
11121192 1 34 30SEP2020 VACCINATION LOST TO FOLLOW -UP unable to reach subject for missed appts
1 34 30SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Unable to contact subject for Vs 2
C4591001
1112
11121229
04SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject left clinic after randomization and prior to
vaccination
C4591001
1112
11121270† 1 1 08OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA unstable viral load and Hepatitis B
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 31
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0129020
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1114
11141029 2 45 29OCT2020 VACCINATION LOST TO FOLL OW-UP Subject no show to apt and no response from certified
letter.
2 45 29OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject no show to apt and no response from certified
letter.
C4591001
1114
11141037 1 54 09OCT2020 VACCINATION LOST TO FOLLOW -UP no show to visit 2,two times.subject no responsive to calls
and voicemails and subjects emerg.contac
1 54 09OCT2020 FOLLOW -UP LOST TO FOLLOW -UP no show to visit 2,two times.subject no responsive to calls
and voicemails and subjects emerg.contac
C4591001
1116
11161015
26AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent. Left site prior to IP
administration.
C4591001
1116
11161143 1 68 14NOV2020 VACCINATION LOST TO FOLLOW -UP Contact attempts 29SEP 30SEP 2OCT 13OCT 6NOV
9NOV
1 68 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Contact attempts 29SEP 30SEP 2OCT 13OCT 6NOV
9NOV
C4591001
1116
11161172 1 67 14NOV2020 VACCINATION LOST TO FOLLOW -UP Contact attempts 2OCT 5OCT 7OCT 9OCT 13OCT
23OCT 9NOV
1 67 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Contact attempts 2OCT 5OCT 7OCT 9OCT 13OCT
23OCT 9NOV
C4591001
1116
11161292 1 52 14NOV2020 VACCINATION LOST TO FOLLOW -UP Contact attempts 16OCT 22OCT 23OCT 3NOV 4NOV
9NOV 10NOV
1 52 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Contact attempts 16OCT 22OCT 23OCT 3NOV 4NOV
9NOV 10NOV
C4591001
1117
11171186 1 21 26OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA SAE EVENT, INVESTIGATOR DETERMINED
SUBJECT NO LONGER MEETS CRITERIA FOR
INCLUSION
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 32
FDA-CBER-2021-5683-0129021
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1120
11201013 1 20 18AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject states he no longer wants to be in study
1 20 18AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject states he no longer wants to be in study
C4591001
1120
11201038
04AUG2020 SCREENING SCREEN FAILURE SCREEN FAILURE
C4591001
1120
11201083 2 71 04NOV2020 VACCINATION LOST TO FOLLOW -UP certified letter sent and moved to lost to follow up
2 71 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up
C4591001
1120
11201085 1 79 23OCT2020 VACCINATION LOST TO FOLLOW -UP subject would not come in office for visit
1 79 23OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject never showed to appointment.
C4591001
1120
11201104 1 50 24SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject states no longer wishes to be in study about to have
weight lost surgery
1 50 24SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject no longer wished to be in study subject is about to
have weight lost surgery
C4591001
1120
11201249 1 50 09OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT IS STILL BEING FOLLOWED JUST
REFUSED VAX 2
1 50 09OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject still being followed. refused vax 2
C4591001
1120
11201252
09SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject was randomized, but had to leave for work. Subject
never return for next appointment
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 33
FDA-CBER-2021-5683-0129022
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1121
11211009 2 40 22OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew due to busy schedule.
2 40 22OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJE CT Subject withdrew consent due to busy schedule. Does not
want to be FU
C4591001
1121
11211025 1 22 16SEP2020 VACCINATION OTHER Participants significant other notified the site, participant is
in jail for the foreseeable future
1 22 16SEP2020 FOLLOW -UP OTHER Subject incarcerated. Subject to be dropped from the study.
C4591001
1122
11221006
03SEP2020 FOLLOW -UP PROTOCOL
DEV IATION Subject randomized in error
C4591001
1122
11221026
11SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/PRESYNCOPE
11SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/VOMITING
C4591001
1123
11231027
04AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent after randomization prior to
vaccination.
C4591001
1123
11231051 2 43 08OCT2020 VACCINATION OTHER moved to hawaii
2 43 08OCT2020 FOLLOW -UP OTHER Moved to Hawaii
C4591001
1123
11231144 1 42 30SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criteria #5.
C4591001
1123
11231154 1 73 04NOV2020 VACCINATION LOST TO FOLLOW -UP no response from subject after certified letter
1 73 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP no response from subject after certified letter
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 34
FDA-CBER-2021-5683-0129023
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1123
11231168 1 72 04NOV2020 VACCINATION LOST TO FOLLOW -UP Pt is LTF
1 72 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Pt is LTF
C4591001
1123
11231290 1 29 21OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subejct withdrew consent.
1 29 21OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent.
C4591001
1123
11231301
24SEP2020 FOLLOW -UP PROTOCOL
DEVIATION subject randomized in error
C4591001
1123
11231313 1 13 06OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exc. criterion 5 COVID -19 positive
C4591001
1123
11231386 1 22 09NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA exclusion no. 5 positive covid test
C4591001
1124
11241049 1 26 11SEP2020 VACCINATION LOST TO FOLLOW -UP Subject not responding to any phone calls, certified letter
sent
1 26 11SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject not responding to any phone calls, certified letter
sent
C4591001
1124
11241084 1 10 02SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or Microbiological COVID 19 Diagnosis
1 18 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject not interested in participating any longer
C4591001
1125
11251019 1 48 29SEP2020 VACCINATION LOST TO FOLLOW -UP lost to follow
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 35
FDA-CBER-2021-5683-0129024
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 48 29SEP2020 FOLLOW -UP LOST TO FOLLOW -UP post to follow
C4591001
1125
11251022 2 57 28OCT2020 VACCINATION LOST TO FOLLOW -UP patient is a lost to follow
2 57 28OCT2020 FOLLOW -UP LOST TO FOLLOW -UP patient was a lost to follow
C4591001
1125
11251148 1 43 14OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject tested positive for Covid -19
C4591001
1125
11251159 1 1 03SEP2020 VACCINATION LOST TO FOLLOW -UP attempted to contact patient a nd sent certified letter wih no
response back
1 1 03SEP2020 FOLLOW -UP LOST TO FOLLOW -UP patient is a lost to follow
C4591001
1125
11251160 1 33 05OCT2020 VACCINATION LOST TO FOLLOW -UP Patient is a lost to follow
1 33 05OCT2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow
C4591001
1126
11261074
25AUG2020 FOLLOW -UP PROTOCOL
DEVIATION During enrollment, after consent signed, inc/exc criteria
reviewed, serology/nasal swab completed
C4591001
1127
11271022 1 50 17SEP2020 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1127
11271099 1 22 09SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject tested positive and symptoms for COVID
C4591001
1128
11281055 2 65 29OCT2020 VACCINATION LOST TO FOLLOW -UP subject contact attempted several times, certified letter sent,
no response
2 65 29OCT2020 FOLLO W-UP LOST TO FOLLOW -UP after several attempts and certified letter, subject has not
responded
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 36
FDA-CBER-2021-5683-0129025
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1128
11281086 2 43 13OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject wishes to discontinue from study
2 43 13OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject wished to discontinue study
C4591001
1128
11281146 1 64 21OCT2020 VACCINATION LOST TO FOLLOW -UP subject is lost to follow up
1 64 21OCT2020 FOLLOW -UP LOST TO FOLLOW -UP AFTER SEVERAL ATTEMPTS TO CONTACT,
CERTIFITED LETTER SENT 16SEP2020
C4591001
1128
11281159 2 49 29OCT2020 VACCINATION LOST TO FOLLOW -UP after several attempts and certified letter sent, subject is lost
to follow up
2 49 29OCT2020 FOLLOW -UP LOST TO FOLLOW -UP after several attempts and certified letter sent, subject is lost
to follow up
C4591001
1128
11281164 2 61 10NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSE NT, GOT A NEW JOB
AND CAN'T RETURN FOR VISITS
2 61 10NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT, GOT A NEW JOB
AND CAN'T RETURN FOR VISITS
C4591001
1128
11281279 2 48 09NOV2020 VACCINATION LOST TO FOLLOW -UP AFTER SEVERAL ATTEMPTS TO REACH SUBJECT,
CERTIFIED LETTER WAS SENT WITH NO
RESPONSE
2 48 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP AFTER SEVERAL ATTEMPTS TO REACH SUBJECT,
CERTIFIED LETTER WAS SENT WITH NO
RESPONSE
C4591001
1128
11281368 1 46 31OCT2020 VACCINATION LOST TO FOLLOW -UP SUBJECT DID NOT RETURN TO CLINIC FOR V2.
CERTIFIED LETTER SENT
1 46 31OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT DID NOT RETURN TO CLINIC FOR V2.
CERTIFIED LETTER SENT
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 37
FDA-CBER-2021-5683-0129026
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1129
11291048
04AUG2020 FOLLOW -UP PROTOCOL
DEVIATION violation exclusion criteria 2 f. immunocompromised.
randomized but not dosed
C4591001
1131
11311024 1 39 24SEP2020 VACCINA TION LOST TO FOLLOW -UP subject received vax1 (17AUG2020) but no showed for
vax2. Now LTFU
1 39 24SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Multiple attempts made after no -show for V2,no
response.Certified letter sent. Signed 24SEP2020
C4591001
1133
11331023 2 36 25SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
2 36 25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331037 1 27 26AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent.
1 27 26AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331042 1 21 20AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent.
1 21 20AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331047 2 8 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject does not want to continue in the study
2 8 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331052 1 10 12AUG2020 VACCINATION LOST TO FOLLOW -UP Certified Letter sent out Subject Lost to Follow up
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 38
FDA-CBER-2021-5683-0129027
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 10 12AUG2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter was sent
C4591001
1133
11331069 2 75 10NOV2020 VACCINATION LOST TO FOLLOW -UP Unable to contact subject
2 75 10NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
C4591001
1133
11331087 1 7 14AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent.
1 7 14AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331119 2 49 10NOV2020 VACCINATION LOST TO FOLLOW -UP Unable to contact subject
2 49 10NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
C4591001
1133
11331122 1 20 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject was called because he was not complying with
the diary. Subject withdrew consent
1 20 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331138 1 24 04SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject stated she is not happy with the study number of
visits, number of vaccines, payments.
1 24 04SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject stated she is not happy with the study number of
visits, number of vaccines, payments.
C4591001
1133
11331162
14AUG2020 SCREENING OTHER DELAY CRITERIA MET
05OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 39
FDA-CBER-2021-5683-0129028
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1133
11331170 1 67 19OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/HYPERTENSION
1 67 19OCT2020 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1133
11331177 2 68 10NOV2020 VACCINATION LOST TO FOLLOW -UP Unable to contact subject
2 68 10NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
C4591001
1133
11331207 1 43 30SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
1 43 30SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331291 1 47 12OCT2020 VACCINATION LOST TO FOLLOW -UP Certified letter sent on 12/OCT/2020
1 47 12OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent on 12/OCT/2 020
C4591001
1133
11331294 2 54 10NOV2020 VACCINATION LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
2 54 10NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
C4591001
1133
11331295 1 44 09OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
1 44 09OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331338 1 50 17OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 40
FDA-CBER-2021-5683-0129029
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 50 17OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331341 1 45 12OCT2020 VACCINATION LOST TO FOLLOW -UP Subject is LTF. Certified letter sent 12/OCT/20
1 45 12OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT IS LTF. CERTIFIED LETTER SENT
12/OCT/20
C4591001
1133
11331348 2 51 10NOV2020 VACCINATION LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
2 51 10NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
C4591001
1133
11331499 2 17 30OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject does not wish to continue with study,he asked us to
please do notcall him again.
2 17 30OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject does not want to be contacted anymore
C4591001
1133
11331509 1 26 20OCT2020 VACCINATION LOST TO FOLLOW -UP Unable to contact subject
1 26 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Unable to contact subject
C4591001
1133
11331510 1 20 14OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject doesn't feels comfortable receiving the second
vaccine.
1 20 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT DOES NOT FEEL COMFORTABLE
RECEIVING 2ND VACCINE. Subject wishies to no
longer be contacted.
C4591001
1133
11331512 1 26 20OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Meets exclusion 5
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 41
FDA-CBER-2021-5683-0129030
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1134
11341033 1 35 14SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Dropped
1 35 14SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1134
11341153 1 2 25AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/ABDOMINAL DISCOMFORT
1 2 25AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DIARRHOEA
1 2 25AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/EYE PAIN
1 2 25AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/FATIGUE
1 2 25AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/HEADACHE
1 2 25AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/MUSCULAR WEAKNESS
C4591001
1134
11341174 1 5 30AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/HEADACHE
1 5 30AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/INJECTION SITE PAIN
1 5 30AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/PAIN IN EXTREMITY
C4591001
1134
11341210 2 1 18SEP2020 VACCINATION LOST TO FOLLOW -UP subject is lost to follow up
2 1 18SEP2020 FOLLOW -UP LOST TO FOLLOW -UP subject is lost to follow up
C4591001
1135
11351061 1 57 02OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent
1 57 02OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 42
FDA-CBER-2021-5683-0129031
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1135
11351132 2 38 08OCT2020 VACCINATION LOST TO FOLLOW -UP subject contact attempted several times, certified letter
mailed on 08OCT2020.
2 38 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject lost to follow -up
C4591001
1135
11351199 1 39 01OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up, certified letter sent to patient.
1 39 01OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject lost to follow -up, certified letter sent
C4591001
1135
11351200 1 54 16OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up, certified letter sent to patient.
1 54 16OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject lost to follow -up, certified letter was sent
C4591001
1135
11351212 1 35 28SEP2020 VACCINATION LOST TO FOLLOW -UP patient was lost to follow up. certified letter was sent.
1 35 28SEP2020 FOLLOW -UP LOST TO FOLLOW -UP subject lost to follow -up, certified letter was sent
C4591001
1135
11351389
19SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT during screening visit, subject withdrew consent after
randomization
C4591001
1135
11351420 1 27 19OCT2020 VACCINATION LOST TO FOLLOW -UP subject contact attempted several times and certified letter
sent 19OCT2020
1 27 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject contact attempted several times and certified letter
sent on 19OCT2020
C4591001
1135
11351428 1 27 19OC T2020 VACCINATION LOST TO FOLLOW -UP subject contact attempted several times and certified letter
was sent on 19OCT2020
1 27 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject contact attempted several times and certified letter
was sent on 19OCT2020
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 43
FDA-CBER-2021-5683-0129032
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1135
11351430 1 26 19OCT2020 VACCINATION LOST TO FOLLOW -UP subject contact attempted several times and certified letter
sent on 19OCT2020
1 26 19OCT2020 FOL LOW -UP LOST TO FOLLOW -UP subject contact attempted several times and certified letter
sent on 19OCT2020
C4591001
1135
11351523 1 18 10NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent
1 18 10NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1136
11361045 1 75 06NOV2020 VACCINATION LOST TO FOLLOW -UP Unable to contact subject after multiple attempts and
certified letter sent
1 75 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Unable to contact subject after multiple attempts and
certified letter.
C4591001
1140
11401177 2 54 03NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT CONSIDERED WITHDRAWING CONSENT
2 54 03NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent via phone on 03Nov2020
C4591001
1140
11401306 1 23 13NOV2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/AMNESIA
1 23 13NOV2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/PARAPARESIS
C4591001
1141
11411146 1 50 16OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject no longer meets eligibility criteria. Exclusion #5
C4591001
1141
11411164 1 58 29OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject declined second vaccination
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 44
FDA-CBER-2021-5683-0129033
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1142
11421084 2 62 04NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Discontinued d/t medical history discovered after
enrollment per instructions of CRA
C4591001
1147
11471035 1 49 23SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Meets exclusion criterion 5
C4591001
1147
11471212 1 21 23SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
1 21 23SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1149
11491005 1 21 25AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT patient will be out of state for a long period of time so
unable to return for study visits
1 21 25AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT pt withdrew consent from study. unable to return for visits
due to upcoming scheduling conflicts
C4591001
1149
11491007 2 18 11SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent and no longer wishes to continue
in study citing personal reasons
2 18 11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent and no longer wishes to
participate in the study due to personal reasons
C4591001
1149
11491031 1 68 16OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up left several VM and certified letter send
09oct2020.
1 68 16OCT2 020 FOLLOW -UP LOST TO FOLLOW -UP patient has been unresponsive to repeated site contacts via
phone, email and certified letter
C4591001
1149
11491065 1 31 11SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT pt is withdrawing consent from study due to personal
reasons
1 31 11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent and does not wish to continue in
study citing personal reasons
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 45
FDA-CBER-2021-5683-0129034
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1149
11491066 1 78 28OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject was asymptomatic and tested positive for COVID -
19 by outside provided.
C4591001
1149
11491067 1 21 01SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT patient withdrew consent from the study
1 21 01SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent and no longer wishes to
participate in the study
C4591001
1149
11491230 1 60 09NOV2020 VACCINATION LOST TO FOLLOW -UP Subject sent LTFU certified letter 30OCT2020.
1 60 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject is non responsive. Certified letter sent 30OCT2020.
C4591001
1152
11521030 1 22 02SEP2020 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1152
11521034 1 41 21SEP2020 VACCINATION LOST TO FOLLOW -UP Several phone messages were left for subject. Certified
letter was sent.
1 41 21SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent; return receipt received back signed by
someo ne other than the subject.
C4591001
1152
11521043 2 10 10SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Now has 2 jobs and has no time to do study.
2 10 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrawal by subject due to time constraints.
C4591001
1152
11521077 2 1 03SEP2020 VACCINATION OTHER Subject had both vaccinations and then moved out of state.
No Visit 3 was or ever will be done.
2 33 05OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT MOVED TO ARIZONA
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 46
FDA-CBER-2021-5683-0129035
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1152
11521085 1 8 26AUG2020 VACCINATION DEATH DEATH
1 8 26AUG2020 FOLLOW -UP DEATH DEATH
C4591001
1156
11561006 1 20 08SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criteria 5
C4591001
1156
11561015 1 39 28SEP2020 VACCINATION PREGNANCY PREGNANCY
C4591001
1156
11561033 1 16 10SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criteria 5
C4591001
1157
11571003 1 56 06OCT2020 VACCINATION LOST TO FOLLOW -UP All attempts to contact subject have not been successful.
1 56 06OCT2020 FOLLOW -UP LOST TO FOLLOW -UP All attempts to contact subject have been unsuccessful
C4591001
1157
11571070 1 38 01OCT2020 VACCINATION LOST TO FOLLOW -UP All attempts to contact subject have been unsuccessful
1 38 01OCT2020 FOLLOW -UP LOST TO FOLLOW -UP All attempts to contact subject have been unsuccessful
C4591001
1157
11571077 2 30 14OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject W/C due to moving
2 30 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Voluntary withdrawal not due to an AE or SAE
C4591001
1157
11571135 1 23 24SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Voluntary withdrawal not due to an adverse event
1 23 24SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Voluntary withdrawal not due to an AE or SAE
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 47
FDA-CBER-2021-5683-0129036
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1161
11611002 1 85 23OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion 5
C4591001
1161
11611008 1 103 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1161
11611023 1 72 13OCT2020 VACCINATION LOST TO FOLLOW -UP subject had several con tact attempts by site along with
certified letter. Unable to contact subject.
1 72 13OCT2020 FOLLOW -UP LOST TO FOLLOW -UP cert. letter sent and signed by subject. unable to contact and
subject has not called site.
C4591001
1161
11611024 1 25 27AUG2020 VACCINATION LOST TO FOLLOW -UP unable to contact subject. certified letter returned, no
response from subject
C4591001
1162
11621005 1 32 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject prematurely withdrew from study.
1 32 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject prematurely withdrawn from study.
C4591001
1162
11621024
06AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Randomized in error
C4591001
1162
11621074 2 73 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP subject LTFU after multiple contact attempts.
C4591001
1162
11621080 2 64 04NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU
2 64 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 48
FDA-CBER-2021-5683-0129037
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1162
11621118 1 35 16SEP2020 VACCINATION LOST TO FOLLOW -UP SUBECT WITHDREW,CERTIFIED LETTER SENT
9/16/2020
1 35 16SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject withdrew from study
C4591001
1162
11621137 2 66 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU after multiple contact attempts.
C4591001
1162
11621164 2 66 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU after multiple contact attempts.
C4591001
1162
11621294 1 60 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU after many contact attempts
1 60 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU after many contact attempts
C4591001
1162
11621310 1 60 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU
1 60 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU
C4591001
1162
11621374 1 54 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU
1 54 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU after many contact attempts.
C4591001
1162
11621477
30SEP2020 FOLLOW -UP PROTOCOL
DEVIATION Randomized in error
C4591001
1163
11631059 1 2 08AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/UPPER BODYRASH DUE TO
VACCINE@@
C4591001
1163
11631069 1 66 14OCT2020 VACCINATION OTHER REHAB
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 49
FDA-CBER-2021-5683-0129038
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1163
11631123 2 58 04NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
2 58 04NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1166
11661037 2 37 15OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject refused further procedures.
2 37 15OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient refused further study procedures. Upda ted per DM.
C4591001
1166
11661047 1 1 31AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DIZZINESS
C4591001
1167
11671003
14AUG2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Did not meet inclusion criteria #3
C4591001
1167
11671111 1 38 08OCT2020 VACCINATION LOST TO FOLLOW -UP Subject is lost to follow up tried multiple calls and certified
letter
1 38 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP no answer after multiple calls and sent certified letter
C4591001
1168
11681030
15AUG2020 SCREENING OTHER randomized in error
15AUG2020 FOLLOW -UP PROTOCOL
DEVIATION subject randomized in error
C4591001
1168
11681070 2 29 02NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Pt. will no longer complete study visits due to her schedule
and withdrew consent to participate
2 29 02NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt would not return for visits as required and chose to no
longer partici pate Verbal WOC
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 50
FDA-CBER-2021-5683-0129039
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1168
11681077 2 28 12OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT PATIENT WITHDREW CONSENT
2 28 12OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient withdrew consent
C4591001
1168
11681097 2 1 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject is unable to complete V3 due to his work. Pt
will complete the rest of the study visits
C4591001
1168
11681104 1 70 05NOV2020 VACCINATION LOST TO FOLLOW -UP multiple attempts to reach patient for missed Visit 2 and no
response.
1 70 05NOV2020 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts to reach patient after missed Visit 2 and
no response.
C4591001
1168
11681178 2 34 10NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT The patient chose to no longer participate due to distance
and an assumption of placebo group
2 34 10NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the subject withdrew consent to participate
C4591001
1169
11691058 1 17 02OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Covid +
C4591001
1170
11701311 1 33 16OCT2020 VACCINATION LOST TO FOLLOW -UP Subject contacted multiple times, never responded.
1 33 16OCT2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow -up subjects subject didnt come for visit.
C4591001
1171
11711004 2 29 28SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject stated they do not want to participate in the study
anymore. Subject withdrew consent.
2 29 28SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject stated they do not want to participate in the study
anymore. Subject withdrew consent.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 51
FDA-CBER-2021-5683-0129040
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1171
11711042 1 39 24SEP2020 VACCINATION LOST TO FOLLOW -UP Per PI instructions subject LTFU
1 39 24SEP2020 FOLLO W-UP LOST TO FOLLOW -UP Per PI instructions subject LTFU
C4591001
1171
11711072 1 37 24SEP2020 VACCINATION LOST TO FOLLOW -UP Per PI instructions subject is LTFU
1 37 24SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Per PI instructions subject LTFU
C4591001
1171
11711131 1 45 09OCT2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU.
1 45 09OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Per PI instructions, subject LTFU.
C4591001
1171
11711159 1 39 08OCT2020 VACCINATION LOST TO FOLLOW -UP Per PI, subject LTFU.
1 39 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Per PI, subject LTFU
C4591001
1177
11771139 1 74 06NOV2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
1 74 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow -up
C4591001
1178
11781107 1 22 25SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/LYMPHADENOPATHY
C4591001
1179
11791138 1 11 03NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5. VAX2 is not given but FUP will be
completed.
C4591001
1194
11941061 1 8 26OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criterion 5
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 52
FDA-CBER-2021-5683-0129041
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1195
11951061 1 21 06NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT patient withdrawal consent. she is afraid about the second
vaccination
C4591001
1203
12031037 1 6 26OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Covid -19 Illness between V1 and V2(Positive self
swab+symptoms) no 2ndvaccination administered.
C4591001
1204
12041197† 1 37 13NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Participant has chosen to withdraw from the study.
C4591001
1205
12051028
30OCT2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/BLOOD PRESSURE INCREASED
C4591001
1207
12071024 1 17 13NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Participant symptomatic COVID +
C4591001
1209
12091013 1 9 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5. VAX2 is not given but follow -up
will be completed
C4591001
1212
12121023
03NOV2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA After PI judgement, subject was not vaccinated.
C4591001
1217
12171044 1 7 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1223
12231200
21SEP2020 FOLLOW -UP PROTOCOL
DEVIATION subject randomized in error
C4591001
1223
12231234
12OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject left the site before vaccination 1
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 53
FDA-CBER-2021-5683-0129042
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1224
12241009 1 37 18SEP2020 VACCINATION LOST TO FOLLOW -UP PT failed to attend V2; site attempted conta ct via phone
and certified letter
1 37 18SEP2020 FOLLOW -UP LOST TO FOLLOW -UP PT failed to return for V2; site attempted contact via phone
and certified letter
C4591001
1224
12241065 1 13 05SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/HEART RATE IRREGULAR
1 13 05SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
C4591001
1226
12261072 1 22 01SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/MYALGIA
C4591001
1226
12261108 2 32 01OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Participant withdrew consent for not wanting to comply
with the study procedures.
2 32 01OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawal by subject
C4591001
1226
12261205 2 51 28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject did not want to continue in the study.
C4591001
1226
12261272 2 28 07OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject withdrew consent due unavailability.
2 28 07OCT2020 FOLLOW -UP REFUSED FURTHER
STUDY PROCEDURES REFUSED FURTHER STUDY PROCEDURES
C4591001
1226
12261409 1 44 07OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject did not want to continue in the studies
procedures.
1 44 07OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject has no more availability to continue in the
study.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 54
FDA-CBER-2021-5683-0129043
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1226
12261894 1 5 29SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA The subject had a RT -PCR test COVID -19, so he was
discontinued from the study, not recieving the V2.
C4591001
1226
12262108 1 20 27OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1226
12262189 1 14 27OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1226
12262267 1 2 18OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criteria 5
C4591001
1229
12291204 1 30 11NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent.
C4591001
1230
12301045† 1 22 20OCT2020 VACCINATION PREGNANCY PREGNANCY
C4591001
1230
12301148 1 23 28OCT2020 VACCINATION OTHER Patient confirmed re -location for work purposes not
foreseen. Not able to attend study visits
1 23 28OCT2020 FOLLOW -UP OTHER Participant relocated and cannot attend study procedures.
C4591001
1230
12301150 1 23 28OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew their consent.
1 23 28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject cannot commit to all the study procedures.
C4591001
1231
12311031 1 37 15SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 55
FDA-CBER-2021-5683-0129044
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12311054 1 45 24SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject refers that the decision to stop participating in
the study is due to lack of time
1 45 24SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT No time necessary to comply with the visits and the
demand that it takes to participate in the study
C4591 001
1231
12311087 1 39 19SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
1 39 19SEP2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Discontinued due to previous clinical or microbiological
diagnosis of COVID -19
C4591001
1231
12311088 1 48 28SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311125 1 23 04SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Participants who, in the judment of the investigator, are at
risk for acquiring COVID -19
C4591001
1231
12311147 1 7 19AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311189 1 39 21SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311191 1 32 14SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311195 1 40 22SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311200 1 22 04SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not sign amendment 5 because he did not
agree
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 56
FDA-CBER-2021-5683-0129045
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 22 04SEP2020 FOL LOW -UP WITHDRAWAL BY
SUBJECT the subject did not sign amendment 5 because he did not
agree
C4591001
1231
12311356 1 64 17OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The volunteer did not specify the reason why she decided
to stop participating.
1 64 17OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The volunteer did not specify the reason why she decided
to stop participating.
C4591001
1231
12311374 1 31 14SEP2020 VAC CINATION WITHDRAWAL BY
SUBJECT The subject reports that the decision to stop participating in
the study is of a personal nature
1 31 14SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject reports that the decision to stop participating in
the study is of a personal nature
C4591001
1231
12311391 1 14 28AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA COVID 19 DIAGNOSIS
1 80 02NOV2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up after several tries of contact
C4591001
1231
12311402 1 30 13SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311409
25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the subject decided to withdraw the consent.
C4591001
1231
12311431 1 27 10SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject is afraid of exposure to COVID -19 in next
study visits
1 27 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT you fear going to a health institution and that this will
expose you to be reinfected by SARS -COV2
C4591001
1231
12311441 1 28 11SEP20 20 VACCINATION WITHDRAWAL BY
SUBJECT for having moved to Gualeguaychu (Province of Entre
Rios)
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 57
FDA-CBER-2021-5683-0129046
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 28 11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT for having moved to Gualeguaychu (Province of Entre
Rios)
C4591001
1231
12311443 1 27 10SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Codiv 19 positive
C4591001
1231
12311473 1 29 12SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311516
13OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT does not want to continue with the controls, after informing
you that it was discontinued.
C4591001
1231
12311532 1 23 07SEP 2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311557 2 46 19OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT He believes that received a placebo and therefore has no
interest in continuing with further control
2 46 19OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject THINKS received placebo, so withdrew consent
C4591001
1231
12311559 1 28 12SEP2020 VACCINATI ON WITHDRAWAL BY
SUBJECT The subject reports that the decision to stop participating in
the study is of a personal nature
1 28 12SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject decided to withdraw consent
C4591001
1231
12311568 1 37 21SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311577 2 57 02NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 58
FDA-CBER-2021-5683-0129047
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12311641 1 29 13SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311656 1 40 24SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311816 1 31 16SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311911 1 38 24SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311926
18AUG2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/SYNCOPE
C4591001
1231
12311973 2 43 20OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The volunteer communicated his desire to withdraw
consent to participate in the study when the alarm
2 43 20OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The volunteer communicated his desire to withdraw
consent to participate in the study when the alarm
C4591001
1231
12311991 1 21 07SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject decided to withdraw consent
1 21 07SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject decided to withdraw consent
C4591001
1231
12311996 2 60 06NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to going to live
abroad.
C4591001
1231
12312176
19AUG2020 FOLLOW -UP PROTOCOL
DEVIATION Subject randomized for error
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 59
FDA-CBER-2021-5683-0129048
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12312186 2 35 13OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal and
work issues.
2 35 13OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal and
work issues.
C4591001
1231
12312244 1 23 10SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312284 1 22 09SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312320 1 61 18OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject with previou s clinically or microbiological
diagnosis of COVID -19
C4591001
1231
12312326 1 34 21SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312334 1 32 19SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312339 1 38 25SEP2020 VACCINA TION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312361 1 68 25OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Inability to attend visits for work reasons
1 68 25OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdraw consent due to personal reasons
C4591001
1231
12312365 1 28 15SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 60
FDA-CBER-2021-5683-0129049
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 56 13OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject decided to withdraw consent due to lack of time
C4591001
1231
12312375 1 26 13SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312403 1 24 11SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The patient does not want to take the second dose.
C4591001
1231
12312451 1 23 11SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Participants who are willing and able to comply with all
scheduled visits, vaccination plan, lab...
C4591001
1231
12312483
20AUG2020 FOLLOW -UP PROTOCOL
DEVIATION subject randomized in error
C4591001
1231
12312559 1 23 11SEP2020 VACCINATION WITHDRAW AL BY
SUBJECT The subject is available to attend the protocol visits
C4591001
1231
12312577 1 9 28AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/METASTASES TO CENTRAL
NERVOUS SYSTEM
C4591001
1231
12312594 1 77 04NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Stop participating for personal reasons
1 77 04NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdraws his consent for personal reasons
C4591001
1231
12312660 1 56 14OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312713 2 35 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reason.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 61
FDA-CBER-2021-5683-0129050
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12312752 1 40 29SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312759 2 36 16OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the volunteer reported her desire to withdraw consent to
participate in the study
2 36 16OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the volunteer reported her desire to withdraw consent to
participate in the study
C4591001
1231
12312763 1 35 24SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312848 1 29 18SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdraws consent. Subject declares she does not
want t o be part of the research study
1 29 18SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdraws consent. Subject declares she does not
want to be part of the research study
C4591001
1231
12312916 1 20 09SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19.
C4591001
1231
12312982 2 15 23SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject reports that the decision to stop participating in
the study is of a per sonal nature
2 15 23SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrawal of consent for personal reasons
C4591001
1231
12313006 1 21 10SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313030 2 37 16OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The decision to stop participating is due to personal
reasons.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 62
FDA-CBER-2021-5683-0129051
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 37 16OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The decision to stop participating is due to personal
reasons.
C4591001
1231
12313068 1 23 13SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313 069 1 35 25SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313115 1 20 10SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313125 1 24 14SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313175 1 32 22SEP2020 VACCINA TION WITHDRAWAL BY
SUBJECT The subject refuses to receive the second dosis of the
investigation product
C4591001
1231
12313207 1 21 11SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The volunteer wishes to have a child with his current
partner in the short term
1 21 11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the volunteer wants to have a child in the short term
C4591001
1231
12313211 1 11 01SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19.
C4591001
1231
12313225 1 20 10SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313357 1 20 11SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 63
FDA-CBER-2021-5683-0129052
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12313376 1 22 13SEP2020 VACCINA TION WITHDRAWAL BY
SUBJECT being written phase 2/3 does not assure you that the safety
of the product has been fully evaluated
1 22 13SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT being written phase 2/3 does not assure you that the safety
of the product has been fully evaluated
C4591001
1231
12313395 1 23 14SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C459 1001
1231
12313428 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The patient decided not to apply the second dose.
C4591001
1231
12313443
23AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT randomized, no vaccinated
C4591001
1231
12313449 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject refused to receive the second dose due to the
previous medication dosis error.
C4591001
1231
12313459 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject made the decision not to receive the second
vaccination
C4591001
1231
12313467 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not agree to be vaccinated a second time,but
will continue in the study
C4591001
1231
12313469 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not want to receive a second dose but did
continue in the study
C4591001
1231
12313479 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject decided not to received second dose of the
investigational product
C4591001
1231
12313486 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not agree to be vaccinated a second time,but
will continue in the study
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 64
FDA-CBER-2021-5683-0129053
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12313492 1 28 19SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not agree to be vaccinated a second time,but
will continue in the study
C4591001
1231
12313497 1 25 16SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not agree to be vaccinated a second time,but
will continue in the study
C4591001
1231
12313498 1 25 16SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not agree to be vaccinated a second time,but
will continue in the study
C4591001
1231
12313506 1 25 16SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject refused to receive the second dose of treatment due
to medication error in the first dose.
C4591001
1231
12313509 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject didnt agree to receive the second dose of the
vaccine but continues in the Study
C4591001
1231
12313510 1 48 09OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criteria: Previous diagnosis (clinical or
microbiological) of COVID -19
C4591001
1231
12313512 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject refused to receive the second dose of the treatment
due to the medication error
C4591001
1231
12313514 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject declined to receive the second vaccination
C4591001
1231
12313517 1 27 18SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject declined to receive the second vaccination
C4591001
1231
12313518 1 25 16SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Did not accept to receive second dose but accept continue
with the rest of study procedures
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 65
FDA-CBER-2021-5683-0129054
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12313519 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Did not accept to receive second dose but accept continue
with the rest of study procedur es
C4591001
1231
12313527
02OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject declined from receiving the investigation product
C4591001
1231
12313528 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject declined to receive the second vaccination
C4591001
1231
12313534 1 28 19SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT medication error in V1, the subject decided not to vaccinate
in V2
C4591001
1231
12313537 1 25 16SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT medication error in V1, subject decided not to vaccinate in
V2
C4591001
1231
12313541 1 26 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject did not receive the second vaccination but
continued otherwise with study procedures
C4591001
1231
12313546 1 26 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject did not receive the second vaccination but
continued otherwise with study procedures
C4591001
1231
12313551 1 27 18SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject did not agree to receive the second dose, but
continues in the study
C4591001
1231
12313554 1 28 19SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject did not agree to receive the second dose, but
continues in the stu dy
C4591001
1231
12313567 1 26 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject did not agree to receive the second dose, but
continues in the study
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 66
FDA-CBER-2021-5683-0129055
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12313592 1 28 19SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19.
C4591001
1231
12313609 2 44 26OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Withdrawal by subject due to personal (work) issues.
2 44 26OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal (work)
issues.
C4591001
1231
12313619 2 43 27OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal issues.
2 43 27OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal issues.
C4591001
1231
12313622 1 24 16SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Healthy participants eligible for inclusion in the study and
Previous diagnosis of COVID -19
C4591001
1231
12313657 1 36 28SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313662 1 26 18SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313699 2 44 27OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT wants to leave the study
2 44 27OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT wants to leave the study
C4591001
1231
12313709 1 52 14OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiol ogical diagnosis of COVID -
19
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 67
FDA-CBER-2021-5683-0129056
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12313758 1 44 06OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313823 2 45 28OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons.
2 45 28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons.
C4591001
1231
12313851 2 40 28OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Personal reason that he preferred not to share
2 40 28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Personal reason that he preferred not to share
C4591001
1231
12313869
25AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the vo lunteer requests that she be withdrawn from the study
C4591001
1231
12313955 2 30 14OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to strict personal
family causes.
2 30 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to strict personal
family causes
C4591001
1231
12313981 2 45 29OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The decision to stop participating must be a move to the
province of Santiago del Estero.
2 45 29OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The decision to stop participating must be a move to the
province of Santiago del Estero.
C4591001
1231
12314030 2 37 23OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons.
2 37 23OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 68
FDA-CBER-2021-5683-0129057
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12314134 1 20 14SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12314179 1 30 24SEP2020 VACC INATION WITHDRAWAL BY
SUBJECT subject withdrew consent after visit 1
1 30 24SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent after visit 1
C4591001
1231
12314205 1 20 14SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Clinical diagnosis of covid 19
C4591001
1231
12314266 1 22 16SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject reports that the decision to stop participating in
the study is of a personal nature
1 22 16SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject reports that the decision to stop participating in
the study is of a personal nature
C4591001
1231
12314314 1 27 21SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject reports that the decision to s top participating in
the study is of a personal nature
1 27 21SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject reports that the decision to stop participating in
the study is of a personal nature.
C4591001
1231
12314381 1 55 20OCT2020 VACCINATION LOST TO FOLLOW -UP Subject did not answer phone call or certified letter.
Contact is considered lost
1 55 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject did not answer phone or certified letter. Contact is
consider lost
C4591001
1231
12314385 1 44 09OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA For meeting the exclusion criterion of previous diagnosis,
subject discontinued
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 69
FDA-CBER-2021-5683-0129058
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12314492 1 20 15SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12314580 1 33 28SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12314590 1 15 10SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The volunteer states that the decision to stop participating
in the study is of a personal nature.
1 15 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The volunteer states that the decision to stop participating
in the study is of a personal nature.
C4591001
1231
12314700 1 22 18SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12314713 1 22 18SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject refused to recieve second dose of investigation
product
C4591001
1231
12314848 1 20 16SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
1 64 30OCT2020 FOLLOW -UP LOST TO FOLLO W-UP after failed attempts of contact by phone and certified letter,
it is consider lost of follow up
C4591001
1231
12314853 2 43 28OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT unforeseen move out of the country, with no probable date
of return.
2 43 28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT unforeseen move out of the country, with no probable date
of return.
C4591001
1231
12314923 1 31 27SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject not being able to continue attending visits.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 70
FDA-CBER-2021-5683-0129059
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 31 27SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject not being able to continue attending visits.
C4591001
1231
12314964 2 48 04NOV2020 VACCINATION LOST TO FOLLOW -UP The v olunteer does not answer calls. Contact was lost, the
study was withdrawn
2 48 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP The volunteer does not answer calls. Contact was lost, the
study was withdrawn
C4591001
1231
12314984 1 21 17SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
1 36 02OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT It is due to having been discontinued from the study.
C4591001
1231
12315269 1 42 09OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12315308
16SEP2020 FOLLOW -UP PROTOCOL
DEVIATION Subject randomized in error
C4591001
1231
12315357 1 13 10SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject does not specif y the reasons for withdrawing
from the study
1 13 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject does not specify the reasons for withdrawing
from the study
C4591001
1231
12315429 1 37 05OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/INJECTION SITE PAIN
1 37 05OCT2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
C4591001
1231
12315441 1 54 22OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DEPRESSION
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 71
FDA-CBER-2021-5683-0129060
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12315600 1 22 21SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject refused to recieve second dose of investigation
product
C4591001
1232
12321015 1 21 02SEP2020 VACCINATION LOST TO FOLLOW -UP patient is labeled a "no show"
1 21 02SEP2020 FOLLOW -UP LOST TO FOLLOW -UP patient labeled as a "no show"
C4591001
1232
12321037
18AUG2020 FOLLOW -UP PROTOCOL
DEVIATION Subject Randomized in Error
C4591001
1232
12321093 2 29 13OCT2020 VACCINATION LOST TO FOLLOW -UP treatment period was not completed
2 29 13OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Treatment period was not completed
C4591001
1232
12321094 2 27 13OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject relocated out of state
2 27 13OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdrew Consent
C4591001
1232
12321100 1 51 15OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA V2 Vaccination was not given due to COVID 19 symptoms
present at that time
C4591001
1232
12321142 1 57 26OCT2020 VACCINATION LOST TO FOLLOW -UP due to subject's job she will not be able to attend
appointments.
1 57 26OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1232
12321175 1 51 23OCT2020 VACCINATION OTHER Subject did not received Vaccination 2
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1232
12321213 1 52 30OCT2020 VACCINATION PREGNANCY PREGNANCY
C4591001
1232
12321293 1 22 22OCT2020 VACCINATION PREGNANCY PREGNANCY
C4591001
1235
12351027 1 18 23SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA COVID -19 positive with symptoms. Will not receive
Vaccine 2.
C4591001
1235
12351071 1 9 22SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Will continue follow up, but will not receive vaccine 2.
C4591001
1235
12351167
09OCT2020 FOLLOW -UP PROTOCOL
DEVIATION randomized but not vaccinated -met exclusion criteria
C4591001
1235
12351187 1 9 24OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA meets exclusion #5
C4591001
1235
12351188 1 7 22OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA positive COVID 19 - exclusion #5
C4591001
1241
12411132 1 2 15AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Discontinued.Exc #5
C4591001
1241
12411144 1 1 17AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Discontinued Exc 5
C4591001
1241
12411260 1 12 30AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Discontinued. Exc#5
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 73
FDA-CBER-2021-5683-0129062
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1241
12411279 1 23 10SEP2020 VACCINATION PREGNANCY PREGNANCY
C4591001
1241
12411482 1 7 31AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Discontinued. RT -PCR SARS Cov -2 Positive
C4591001
1241
12411688 1 13 27SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Discontinued Exc#5
C4591001
1241
12411695 1 4 18SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Discontinued Exc# 5
C4591001
1241
12411766 1 24 09OCT2020 VACCINATION PREGNANCY PREGNANCY
C4591001
1241
12412355 1 22 09NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Discontinued Exc#5
C4591001
1246
12461025 1 22 19OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/URTICARIA
C4591001
1247
12471121 2 10 30OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Patient withdrew from study after motorcycle accident
C4591001
1247
12471149 1 1 01OCT2020 VACCINATION LOST TO FOLLOW -UP Patient not answering calls from site; possibly relocated
1 1 01OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Patient not answering calls from site; could possibly have
relocated
C4591001
1247
12471151 1 22 22OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Pt. sold e -diary smart phone. Does not meet eligibility
Inclusion 2. E -diary deactivated.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 74
FDA-CBER-2021-5683-0129063
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1248
12481018
28AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdrew Consent
C4591001
1248
12481025
29AUG2 020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdrew Consent
C4591001
1248
12481046 1 66 04NOV2020 VACCINATION LOST TO FOLLOW -UP Missed V2 on 20Sep2020; site has been unable to contact
subject despite multiple calls.
1 66 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Please see EOT page
C4591001
1248
12481048 1 66 04NOV2020 VACCINATION LOST TO FOLLOW -UP Subject missed V2 on 20Sep2020; multiple attempts to
reach subject were unsuccessful.
1 66 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Please see EOT page.
C4591001
1248
12481060
02SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Participant withdrew consent
C4591001
1248
12481110 1 59 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject was no show for V2; unable to contact subject.
1 59 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject was no show for V2; unable to contact subject.
C4591001
1248
12481175 1 22 06OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1248
12481199 1 35 21OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
1 35 21OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0129064
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1248
12481218
21SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT
21SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/SYNCOPE
C4591001
1251
12511095 1 21 21SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject wished to withdraw from the study
1 21 21SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1251
12511207 1 1 23SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA clinical diagnosis of Covid -19
C4591001
1254
12541023 1 25 21SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Per PI, subject no longer meets eligibility crite ria by
meeting exclusion #1
C4591001
1254
12541116 1 21 29SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT PATIENT WITHDREW CONSENT
1 21 29SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject called the site and withdrew consent without any
specific reason.
C4591001
1254
12541142 1 26 07OCT2020 VACCINATION PREGNANCY PREGNANCY
C4591001
1260
12601049
02SEP2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA hypertension after randomization so withdrawn from study
C4591001
1260
12601070
04SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT pt withdrawal due to pregnancy partner protocol guidelines
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0129065
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1260
12601126 1 30 16OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT patient refusing vaccination # 2 at this time but she will
continue with the rest of the visits
C4591001
1264
12641018
25AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew prior to IP administration due to needing
MMR booster.
25AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject randomized but remembered she had an MMR
vaccine within la st 28 days and would need booster.
C4591001
4444
44441025 1 12 02OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
4444
44441043 1 19 09OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA diagnosis covid 19 illness
C4591001
4444
44441044 1 16 06OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Positive COVID -19 Diagnosis
C4591001
4444
44441048 1 18 08OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Husband is a cancer patient and asked her not to continue
for the fear of her going to a hospital
1 18 08OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Husband is a cancer patient and asked her not to continue
for the fear of her going to a hospital
C4591001
4444
44441079 1 22 12OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT disagree with not knowing whether to receive placebo or
research product
1 22 12OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT disagree with not knowing whether to receive placebo or
research product
C4591001
4444
44441135
21SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT She does not want to be part of the study due to personal
problems.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0129066
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
4444
44441179 1 22 12OCT2020 VACC INATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal
problems.
1 22 12OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal
problems.
C4591001
4444
44441224 2 31 12NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT due to the fact that he did not agree to their follow -up for
the covid disease
2 31 12NOV2020 FOLLOW -UP WITHDRAW AL BY
SUBJECT due to the fact that he did not agree to their follow -up for
the covid disease
C4591001
4444
44441273 1 24 15OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject expressed his decision to stop participating for
work reasons.
1 24 15OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject expressed his decision to stop participating for
work reasons.
C4591001
4444
44441522 1 21 12OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT For work reasons he is unable to complete the visits
scheduled by protocol
1 21 12OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT For work reasons he is unable to complete the visits
scheduled by protocol
C4591001
4444
44441560 1 10 02OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Positive COVID -19 diagnosis.
C4591001
4444
44441569 1 22 14OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons
1 22 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons
C4591001
4444
44441572 1 31 23OCT2020 VACCI NATION NO LONGER MEETS
ELIGIBILITY CRITERIA Participant who is willing and able to comply with all study
procedures
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0129067
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
4444
44441818 1 28 22OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT He refers not being able to continue with the study due to
personal problems.
1 28 22OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT He refers not being able to continue with the study due to
personal problems.
C4591001
4444
44441931 1 21 15OCT2020 VACCINA TION WITHDRAWAL BY
SUBJECT For recommendation of his doctor.
C4591001
4444
44441951 1 43 06NOV2020 VACCINATION LOST TO FOLLOW -UP 30OCT unsuccessful phone call 06NOV registered letter is
sent. Still no answer
1 43 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP 30OCT unsuccessful phone call 06NOV registered letter is
sent. Still no answer
C4591001
4444
44441979 1 21 15OCT2020 VACCINATI ON PREGNANCY PREGNANCY
1 48 11NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to particular
reasons
C4591001
4444
44442107 1 48 13NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT personal motives
1 48 13NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT personal motives
C4591001
4444
44442194 1 20 16OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating must be traveled abroad.
1 20 16OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating must be traveled abroad.
C4591001
4444
44442263 1 24 20OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Will not be able to continue in the trial since she has had to
travel abroad for personal reasons
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 79
FDA-CBER-2021-5683-0129068
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 24 20OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Will not be able to continue in the trial since she has had to
travel abroad for personal reasons
C4591 001
4444
44442293 1 39 04NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal
problems.
1 39 04NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal
problems.
C4591001
4444
44442319 1 37 02NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Due to a psychiatric condition, subject expresses his desire
to withdraw consent
1 37 02NOV2020 FOLLOW -UP WITHDR AWAL BY
SUBJECT Due to a psychiatric condition, subject expresses his desire
to withdraw consent
>55 C4591001
1005
10051214 1 11 13SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/FACIAL PAIN
1 11 13SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/SWELLING FACE
C4591001
1005
10051403 1 4 07NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA DISCONTINUATION AS SUBJECT TESTED POSITIVE
FOR COVID 19
C4591001
1006
10061020 1 36 16SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/CORONARY ARTERY
OCCLUSION
1 36 16SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
C4591001
1007
10071101 2 63 21OCT2020 FOLLOW -UP DEATH DEATH
C4591001
1007
10071114 1 22 24AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA meets inc #3; Per subI Recent loss of taste & smell,
anorexia & dizziness with gait instability
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0129069
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1007
10071347 1 22 05NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject did not meet inclusion cr iteria #3
C4591001
1008
10081639 1 6 24OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Tested positive for COVID 19
C4591001
1009
10091020 1 14 24AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT WITHDRAWAL BY SUBJECT
1 14 24AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT WITHDRAWAL BY SUBJECT
C4591001
1009
10091157 1 21 24SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent
1 21 24SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1011
10111181 1 1 08OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/PARAESTHESIA ORAL
C4591001
1012
10121149 1 53 30OCT2020 VACCINATION LOST TO FOLLOW -UP No call now show for two scheduled appointments and no
response to certified letter sent.
1 53 30OCT2020 FOLLOW -UP LOST TO FOLLOW -UP No call, no show for 2 scheduled visits and no response to
certified letter
C4591001
1013
10131097
06AUG2020 SCRE ENING OTHER SUBJECT WAS ALREADY RANDOMIZED BUT DID
NOT MEET CRITERIA FOR VACCINATION.
SUBJECT IS DISCONTINUTED.
06AUG2020 FOLLOW -UP PROTOCOL
DEVIATION SUBJECT DID NOT MEET EXCLUSION #5 BUT WAS
ALREADY RANDOMIZED INTO STUDY. DID NO
RECEIVE VACCINATION.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0129070
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1013
10131123 2 70 09NOV2020 VACCINATION LOST TO FOLLOW -UP UNKNOWN
2 70 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP UNKNOWN
C4591001
1013
10131192 1 23 08SEP2020 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
1 23 08SEP2020 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1013
10131509 2 29 29OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT FROM THE
STUDY.
C4591001
1019
10191033
13AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent after being randomized.
C4591001
1019
10191201 1 50 30OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subjec t was still enrolled in another study while being
enrolled in this one.
C4591001
1019
10191300
22OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent after being randomized.
22OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent after being randomized.
C4591001
1022
10221015
17AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient changed his mind after randomization but before
vaccination
C4591001
1022
10221057
25AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient withdrew IFC.
C4591001
1022
10221150
09SEP2020 FOLLOW -UP OTHER IP was quarantined after patient was rando mized
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1024
10241077 1 28 21SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent, will not return to clinic for any
visits/procedures - wants no contact
1 28 21SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient withdrew consent
C4591001
1024
10241130† 1 9 28OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CR ITERIA patient no longer qualifies for vacc#2 due to meeting
exclusion criteria #5
C4591001
1027
10271206† 1 31 30OCT2020 VACCINATION LOST TO FOLLOW -UP Site attempted to contact subject on multiple occasions and
certified letter was sent.
1 31 30OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Site attempted to contact subject on multiple occasions and
certified letter was sent.
C4591001
1037
10371057
24AUG2 020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT NOT WILLING TO ATTEND VISITS AFTER
RANDOMIZATION WAS COMPLETED
C4591001
1037
10371117
18SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject did not want to wait to receive Flu vaccine
C4591001
1039
10391019 1 24 16SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Due to previous medical condition, patient now requires
treatment with corticosteroid.
C4591001
1042
10421010 1 21 19AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent
1 21 19AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1044
10441113
11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent to participate
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0129072
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1046
10461259 1 22 05OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject Decision to With Draw
1 22 05OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Decision
C4591001
1047
10471011 2 11 18SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew conset
2 11 18SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient withdrew consent
C4591001
1047
10471252 1 22 12OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA The subject was diagnosed and had symptomatic Covid
C4591001
1052
10521020 1 21 10SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrawl by subject
1 21 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawl by patient
C4591001
1052
10521062 1 26 25SEP2020 VACCINATION LOST TO FOLLOW -UP n/a
1 26 25SEP2020 FOLLOW -UP LOST TO FOLLOW -UP los to follow up
C4591001
1054
10541071
28AUG2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Re-screened and randomized as subj 10541083.
C4591001
1054
10541175
21SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent due to personal reasons
C4591001
1054
10541186 1 1 23SEP2020 VACCINATION ADV ERSE EVENT ADVERSE EVENT/DIZZINESS
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 84
FDA-CBER-2021-5683-0129073
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 1 23SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/NAUSEA
C4591001
1055
10551039 1 23 04SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject willing to continue in study off medication
C4591001
1056
10561018 1 19 09SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT STATED SHE DOES NOT WANT TO
CONTINUE HER PARTICIPATION IN THE STUDY.
1 19 09SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1056
10561078
28AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt. referred she did not want to continue in the study.
C4591001
1056
10561079 1 55 21OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT STATED SHE IS SCARED OF THE
VACCINE AFTER WATCHING NEWS REPORT
ABOUT SAFETY CONCERNS.
1 55 21OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT STATED SHE IS SCARED OF THE
VACCINE AFTER WATCHING NEWS REPORT
ABOUT SAFETY CONCERNS.
C4591001
1056
10561083 2 30 15OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT PT STATED HE HAS TO LEAVE THE COUNTRY DUE
TO A PERSONAL EMERGENCY ANDHE WILL NOT
BE ABLE TO CONTINUE
2 30 15OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT PT STATED HE HAS TO LEAVE THE COUNTRY DUE
TO A PERSONAL EMERGENCY ANDHE WILL NOT
BE ABLE TO CONTINUE
C4591001
1056
10561120 1 25 25SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject expressed his desire to withdrew his participation
in the trial.
1 25 25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject expressed his desire to withdrew his participation
in the trial.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0129074
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1056
10561123 1 24 24SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject states he doesn't want to continue in the study.
1 24 24SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject states he doesn't want to continue in the study.
C4591001
1056
10561275 1 51 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
1 51 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
C4591001
1056
10561276 1 20 06OCT2020 VACCINATION WITHDRA WAL BY
SUBJECT SUBJECT STATED HE DOES NOT WANT TO
CONTINUE PARTICIPATING IN THE TRIAL.
1 20 06OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT STATED HE DOES NOT WANT TO
CONTINUE PARTICIPATING IN THE TRIAL.
C4591001
1056
10561298 1 50 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
1 50 06NOV2020 FOLLOW -UP LOST TO F OLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
C4591001
1056
10561371 1 38 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
1 38 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
C4591001
1066
10661128 1 20 15SEP2020 VACCINATION WITHDRA WAL BY
SUBJECT discontinued/refused vaccination #2
C4591001
1066
10661350 1 16 03NOV2020 VACCINATION DEATH DEATH
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 16 03NOV2020 FOLLOW -UP DEATH DEATH
C4591001
1071
10711023 1 12 23AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/CORONARY ARTERY DISEASE
1 17 28AUG2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
C4591001
1071
10711063 1 13 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
1 13 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1071
10711169 1 31 15OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/ALCOHOL POISONING
1 31 15OCT2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
C4591001
1071
10711216 1 5 13OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA SUBJECT HAD POSITIVE COVID TEST PRIOR TO
VISIT 2
C4591001
1072
10721065 1 22 18SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Withdrawal by subject
1 22 18SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawa l by subject
C4591001
1079
10791057 1 38 11SEP2020 VACCINATION LOST TO FOLLOW -UP Subject is lost to follow up
1 38 11SEP2020 FOLLOW -UP LOST TO FOLLOW -UP subject is lost to follow up
C4591001
1080
10801064 1 50 07OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Patient did not wish to recieve Vax2 but agreed to continue
in study.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 87
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1082
10821029 2 1 25AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject completed vaccination 2 but did not complete the 1
month follow -up.
2 29 22SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject completed vaccination 2 but did not complete the 1
month follow -up.
C4591001
1082
10821062
06AUG2020 FOLLOW -UP PROTOCOL
DEVIATION Subject was randomized but did not receive study
vaccination. Subject left site prior to vaccination
C4591001
1082
10821126 1 1 21AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent prior to receiving the second
vaccina tion.
1 33 22SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject did not complete follow -up period.
C4591001
1082
10821164 1 25 12OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject believes that his first vaccine is what caused him to
be COVID +.
1 25 12OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject believes that his first vaccine is what caused him to
be COVID +.
C4591001
1083
10831173 1 68 02NOV2020 VACCINATION ADV ERSE EVENT ADVERSE EVENT
C4591001
1084
10841180 2 53 26OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject dropped from trial
2 53 26OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew from trial
C4591001
1084
10841184 2 53 26OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew from trial
2 53 26OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew from trial
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1084
10841366
09SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject left during vaccine prep, was called and texted w/o
response. Dropped from study.
C4591001
1084
10841446
25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew from trial
C4591001
1087
10871080 1 44 24SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Withdrew consent d/t frustrations with limitations of
double -blind study.
1 44 24SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent d/t frustrations with limitations of
double -blind study.
C4591001
1087
10871121 1 22 09SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/GASTROINTESTINAL
HAEMORRHAGE
1 22 09SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
C4591001
1087
10871211 1 24 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Withdrawal of consent to participate in study due to not
being able to get cash off of the ClinCard.
1 24 17SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrawal of consent to participate in study due to not
being able to get cash off of the ClinCard.
C4591001
1087
10871228 1 22 16SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/CARDIAC FAILURE CONGESTIVE
1 22 16SEP2020 FOLLOW -UP ADVERSE EVENT ADV ERSE EVENT
C4591001
1087
10871434
11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt withdrew consent noting it would be very difficult to
ever collect blood from her.
C4591001
1087
10871505 1 23 13OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Pt reports she has a lot going on in her personal life &
wishes to discontinue study.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 89
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 23 13OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt reports she has a lot going on in her life & wishes to
discontinue study.
C4591001
1087
10871512
22SEP2020 FOLLOW -UP PROTOCOL
DEVIATION Subject randomized in error
C4591001
1089
10891098 2 30 29SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject came by office an not longer wanted to do trial.
returned diary
2 30 29SEP20 20 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject came by office an not longer wanted to do trial.
returned diary
C4591001
1089
10891344 1 35 26OCT2020 VACCINATION LOST TO FOLLOW -UP contacts attempted and certified letter sent
1 35 26OCT2020 FOLLOW -UP LOST TO FOLLOW -UP several attempts have been made to contact subject and
certified letter sent. LTFU
C4591001
1090
10901141 2 9 08SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT pt is moving away and not able to come to visits any
longer. He talked to PI
2 9 08SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject moved away
C4591001
1090
10901415 1 58 13NOV2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/HEADAC HE
C4591001
1091
10911092
10AUG2020 FOLLOW -UP OTHER subject randomized with incorrect subject demographics,
was not dosed, then withdrawn and rescreened
C4591001
1092
10921191 1 35 20OCT2020 VACCINATION LOST TO FOLLOW -UP Subject did not show for visit 2 unable to make contact
with subject
1 35 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not return for V2
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1092
10921268 1 5 26OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject tested positive for COVID -19 and meets EC #5
C4591001
1093
10931050 1 24 16SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA PER PROTOCOL, PT WILL NOT RECEIVE SECOND
VAX DUE TO POSITIVE COVID (SYMPTOMATIC),
WILL STILL CONTINU
C4591001
1094
10941080 1 24 25SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrawal of consent by subject
1 24 25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawal of consent by patient
C4591001
1094
10941130 1 32 16OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
1 32 16OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1095
10951102 1 35 10SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Unwilling to come back for appt at this time. Participant
did not verbalize withdrawing consent
1 35 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Unwilling to come back for appt at this time. Participant
did not verbalize withdrawing consent
C4591001
1095
10951107 2 33 28SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT due to ongoing medical issues
C4591001
1095
10951108 2 33 28SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT participant withdrew to care for husbands ongoing medical
needs
C4591001
1096
10961048 1 28 14SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 28 14SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrew consent
C4591001
1096
10961082 1 54 12OCT2020 VACCINATION LOST TO FOLLOW -UP LTFU, unresponsive to contact attempts
1 54 12OCT2020 FOLLOW -UP LOST TO FOLLOW -UP site unable to contact subject after multiple attempts and
certified letter sent
C4591001
1096
10961086 1 52 11OCT2020 VACCINATION LOST TO FOLLOW -UP LTFU, unresponsive to contact attempts
1 52 11OCT2020 FOLLOW -UP LOST TO FOLLOW -UP LTFU, unresponsive to contact attempts
C4591001
1096
10961160 1 47 13OCT2020 VACCINATION LOST TO FOLLOW -UP unable to reach subject despite numerous attempt and
certified letter was sent
1 47 13OCT2020 FOLLOW -UP LOST TO FOLLOW -UP unable to reach subject despite numerous attempt and
certified letter was sent
C4591001
1097
10971003
17AU G2020 FOLLOW -UP PROTOCOL
DEVIATION Randomized in error.
C4591001
1097
10971033 1 23 16SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Patient decided that he no longer wanted to be involved in
the trial.
1 23 16SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt decided that he no longer wanted to be involved in the
trial.
C4591001
1098
10981026 2 33 26OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject no longer wanted to participate in the study.
2 33 26OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT no reason given.
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1098
10981030 1 17 06SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject Withdraw consent and no longer interested in
participating in research trial.
1 17 06SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent because he beleived site has
infected him with Covid -19 .
C4591001
1098
10981092
03SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawl
C4591001
1098
10981109
04SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject unable to be compliant and comit to schedule
visitand vaccination plans.
C4591001
1098
10981130 2 30 28OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew the consent , as he was will be not able to
be compliant in the future.
2 30 28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew the consent , as he was will be not able to
be compliant in the future.
C4591001
1109
11091093 2 45 07OCT2020 VACCINATION LOST TO FOLLOW -UP Subject never return for visit, returned call or returned
certified letter.
2 45 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject never return for visit, returned call or returned
certified letter.
C4591001
1109
11091095 2 37 29SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject called site and withdrew consent today.
2 37 29SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject called site and withdrew consent today.
C4591001
1109
11091248 1 25 09SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT CALLED WHEN V -2 WAS MISSED AND
SHE STATED NO LONGER WANTING TO
PARTICIPATE.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 25 09SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT CALLED WHEN V -2 WAS MISSED AND
SHE STATED NO LONGER WANTING TO
PARTICIPATE.
C4591001
1109
11091253 2 46 20OCT 2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT
2 46 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT
C4591001
1109
11091259
16AUG2020 FOLLOW -UP PROTOCOL
DEVIATION Randomized in error
C4591001
1109
11091475 1 51 29OCT2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO CAL LS OR
CERTIFIED LETTER
1 51 29OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO CALLS OR
CERTIFIED LETTER
C4591001
1109
11091503 1 20 30SEP2020 VACCINATION ADVERSE EVENT Subject declined second vaccine however is willing to
continue followup if approved by sponsor./ABDOMINAL
PAIN UPPER
C4591001
1111
11111112 2 32 05OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent verbally due to no longer
wanting to participate
2 32 05OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrawal
C4591001
1112
11121052 1 50 22SEP2020 VACCINATION LOST TO FOLLOW -UP unable to reach subject for follow up visits
1 50 22SEP2020 FOLLOW -UP LOST TO FOLLOW -UP unable to reach subject to return for follow up visits
C4591001
1112
11121118 1 2 12AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/TACHYCARDIA
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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FDA-CBER-2021-5683-0129083
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1112
11121134 1 38 24SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject no longer wishes to continue
1 38 24SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject does not wish to continue in study
C4591001
1112
11121255 1 2 07OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/CHILLS
1 2 07OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/HEADACHE
1 2 07OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/PYREXIA
C4591001
1112
11121337 1 6 26OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/FATIGUE
1 6 26OCT2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/DIARRHOEA
C4591001
1116
11161117
03SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT ICF Withdrawn
C4591001
1116
11161118
03SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT ICF Withdrawn
C4591001
1116
11161253 1 11 28SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Patient was symptomatic and tested positive for COVID -19
between Vaccine 1 and Vaccine 2
C4591001
1118
11181065 1 50 07OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent prior to coming in for visit 2
after visit 2 was missed multiple ti mes
1 50 07OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject missed visit 2 appointment and has not returned
any contact attempts from the site.
C4591001
1118
11181072 1 54 12OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Refused vaccination 2, consents to follow -up study
procedures (blood draws, diary, phone calls)
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1118
11181090 2 21 05OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent
2 21 05OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT WITHDREW CONSENT
C4591001
1120
11201066 1 66 09OCT2020 VACCINATION LOST TO FOLLOW -UP UNABLE TO BE REACHED FOR VISIT 2
1 66 09OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject phone disconnected emergency contact can't be
reached and certified letter sent no response
C4591001
1120
11201073 1 24 28AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT subject refused vax 2. will follow subject throughout
duration of study
C4591001
1120
11201127 1 4 14AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DIARRHOEA
1 4 14AUG2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
C4591001
1120
11201182 2 37 09OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject stated he wanted to withdraw
2 37 09OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject stated he wanted to withdraw
C4591001
1120
11201335 1 11 26OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5 VAX2 is not given but FUP will be
completed
C4591001
1120
11201408 1 2 29OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DEPRESSION
C4591001
1125
11251211 1 53 02NOV2020 VACCINATION OTHER did not receive 2nd vax
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1125
11251222 1 9 05NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5.
C4591001
1128
11281023
01AUG2020 FOLLOW -UP OTHER unable to obtain lab sample, therefore subject was
discontinued
C4591001
1128
11281109
12AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject changed his mind regarding participation in the
Covid clinical trial
C4591001
1128
11281212 2 33 19OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
2 33 19OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT TO PROCEED IN
STUDY
C4591001
1129
11291082
10AUG2020 FOLLOW -UP PROTOCOL
DEVIATION randomized but not dosed. failed exclusion criteria g.
bleeding condition
C4591001
1129
11291117
17AUG2020 FOLLOW -UP PROTOCOL
DEVIATION failed exclusion criteria L. - participation in other studies.
randomized but not dosed
C4591001
1133
11331080 2 49 15OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
2 49 15OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331168 2 34 07OCT2020 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
2 34 07OCT2020 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1133
11331174 2 57 30OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject refuse to be compliant with diary. He is not longer
interesting in study.
C4591001
1133
11331197
19AUG2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA subject received shingle vaccine on 7/22/2020, subject was
not dosed
C4591001
1133
11331426 1 34 12OCT2020 VACCINATION LOST TO FOLLOW -UP SUBJECT IS LTF. CERTIFIED LETTER SENT
12/OCT/20
1 34 12OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT IS LTF. CERT IFIED LETTER SENT
12/OCT/20
C4591001
1133
11331472 1 33 20OCT2020 VACCINATION LOST TO FOLLOW -UP Unable to contact subject
1 33 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Unable to contact subject
C4591001
1133
11331481 1 24 14OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject doesn't feels comfortable receiving the second
vaccine.
1 24 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject does not feel comfortable receiving 2nd vaccine
and withdrew consent from follow up as well
C4591001
1134
11341130
20AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1135
11351019 2 29 22SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent during V3 on 22SEP2020
C4591001
1140
11401002 2 12 28AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject no longer wanted to participate after experiencing a
spontaneous coronary artery dissection
2 32 17SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject no longer wanted to participate after experiencing a
spontaneous coronary artery dissection
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
Page 98
FDA-CBER-2021-5683-0129087
16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1140
11401003 2 32 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Not interested in remaining in study
2 32 17SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject not interested in continuing. Have been unable to
reach to have come in for follow up
C4591001
1140
11401035 1 50 22SEP2020 VACCINATION ADVERSE EVENT ADVERS E EVENT/URTICARIA
1 50 22SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT
C4591001
1142
11421111 1 19 04SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/ABDOMINAL PAIN
1 19 04SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/NIGHT SWEATS
C4591001
1145
11451041 2 49 02NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT volunteer withdrawn no longer wants to be part of study.
2 49 02NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT volunteer refuses to come for additional visits.
C4591001
1145
11451076 1 18 21SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/PARKINSONISM
C4591001
1147
11471004 1 58 29SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Meets exclusion criterion 5
C4591001
1149
11491105 2 61 09NOV2020 VACCINATION LOST TO FOLLOW -UP Subject is non responsive. Certified letter sent 30OCT2020.
2 61 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject is non responsive. Certified letter sent 30OCT2020.
C4591001
1149
11491117 1 47 06OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent via phone call
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 47 06OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject wit hdrew consent via phone conversation.
C4591001
1149
11491126 1 71 30OCT2020 VACCINATION LOST TO FOLLOW -UP Subject was mailed certified letter 30OCT2020.
1 71 30OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Certified Letter sent 30OCT2020
C4591001
1149
11491224 1 61 09NOV2020 VACCINATION LOST TO FOLLOW -UP Subject is non responsive. Certified letter sent 30OCT2020.
1 61 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject is non responsive. Certified letter sent 30OCT2020.
C4591001
1152
11521359 1 8 11SEP2020 VACCINATION ADVERSE EVENT Subject does not want to receive second vaccination due to
the AEs she had./MUSCLE SPASMS
C4591001
1152
11521476 1 21 15OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DEAFNESS UNILATERAL
C4591001
1152
11521497 1 31 06NOV2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/SYNCOPE
C4591001
1156
11561044 1 13 08SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA EXCLUSION CRITERIA #5
C4591001
1157
11571028
17AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject could not make future study appointments
C4591001
1157
11571131 1 23 24SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Voluntary withdrawal not due to an adverse event
1 23 24SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Voluntary withdrawal not due to an AE or SAE
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1162
11621327 1 4 13SEP2020 VACCINATION DEATH Cause of Death Atherosclerotic Disease
1 4 13SEP2020 FOLLOW -UP DEATH DEATH
C4591001
1162
11621349 1 58 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU after many contact attempts
1 58 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU after many contact attempts
C4591001
1163
11631100 1 48 28SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject did not receive 2nd vaccination due to getting flu
shot 6 days before V2 visit.
C4591001
1168
11681012 2 29 01OCT2 020 VACCINATION WITHDRAWAL BY
SUBJECT patient withdrew consent
2 29 01OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient withdrew consent
C4591001
1168
11681015 1 21 02SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Patient withdrew consent
1 21 02SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient withdrew consent
C4591001
1170
11701354 1 29 16OCT2020 VACCINATION LOST TO FOLLOW -UP Subject contacted multiple times, never responded.
1 29 16OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject contacted multiple times, never responded.
C4591001
1174
11741041 2 35 03NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject withdrew from the trial before completing visit
three for a personal reason
2 35 03NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject has withdrawn from the study overall
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1178
11781056
31AUG2020 FOLLOW -UP PROTOCOL
DEVIATION subject randomized in error
C4591001
1179
11791065 2 45 13NOV2020 VACCINATION LOST TO FOLLOW -UP Despite repeated attempts to contact subject to scheduled
V3 subject has not replied by final notice
2 45 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Despite repeated attempts to contact subject to scheduled
V3 subject has not replied by final notice
C4591001
1185
11851006
27OCT2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA discontinued
C4591001
1204
12041057 1 59 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew from the study.
1 59 05NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdrew from the study.
C4591001
1223
12231215
30SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject left after signing consent, before dosing and did not
return.
C4591001
1223
12231250
16OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject changed his mind.
C4591001
1224
12241012 1 13 25AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/ANKLE FRACTURE
1 13 25AUG2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/FALL
1 13 25AUG2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/MUSCULAR WEAKNESS
1 13 25AUG2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/TRANSIENT ISCHAEMIC
ATTACK
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1224
12241033 2 37 15OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Dissatisfied with trial procedures.
C4591001
1224
12241157
16SEP2020 FOLLOW -UP PROTOCOL
DEVIATION PT is dialysis recipient; screen failure determined by study
team during V1. PT discontinued
C4591001
1226
12261613 1 22 28SEP2020 VACCINATION WITHDRA WAL BY
SUBJECT Patient chose not to take the second dose of the vaccine.
Continue to the next visit
C4591001
1229
12291041 1 35 02NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject is no longer interested in being part of the study.
1 35 02NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject is no longer interested in being part of the study.
C4591001
1231
12311154 2 35 07OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The subje ct in V3 at the moment of re -consenting decided
not to.
2 35 07OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject did not consent for amendment 6
C4591001
1231
12311329 2 39 12OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Withdraws consent due to aggravation of chronic low back
pain
2 39 12OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdraws consent due to aggravation of chronic low back
pain
C4591001
1231
12311400 2 48 21OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The volunteer signed up to participate in another study.
2 48 21OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The volunteer signed up to participate in another study.
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12311549 1 37 21SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311709 1 37 22SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311723 1 23 08SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12311810 2 31 07OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The subjects affirms that the desition to stop participating
in the study is personal
2 31 07OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subjects affirms that the desition to stop participating
in the study is personal
C4591001
1231
12311935 1 22 08SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19.
C4591001
1231
12312058 2 43 29OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to family reasons.
2 43 29OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to family reasons.
C4591001
1231
12312130 1 38 24SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY C RITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312222
19AUG2020 FOLLOW -UP PROTOCOL
DEVIATION Subject randomized in error
C4591001
1231
12312530 2 19 28SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the volunteer refers that the decision to stop participating is
due to personal reasons
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 19 28SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the volunteer refers that the decision to stop participating is
due to personal reasons
C4591001
1231
12312571 1 28 16SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12312855 2 26 04OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is for personal reasons
2 26 04OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is for personal reasons
C4591001
1231
12313003 1 20 09SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The volunteer states that the decision to stop participating
in the study is of a personal nature.
1 20 09SEP2020 FOL LOW -UP WITHDRAWAL BY
SUBJECT The volunteer states that the decision to stop participating
in the study is of a personal nature.
C4591001
1231
12313039 1 29 19SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject reports that the decision to stop participating in
the study is of a personal nature
1 29 19SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject reports that the decision to stop participating in
the study is of a personal nature
C459100 1
1231
12313090 1 46 06OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313103 1 31 21SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313457 1 33 24SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12313461 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject declined to receive second vaccination but wishes
to continue in the study
C4591001
1231
12313468 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject decides not to take the 2nd dose of the research
product, and continues in follow -up
C4591001
1231
12313478 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject explained that he didn't want to receive the
second dose of investigatio n product
C4591001
1231
12313480 1 25 16SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not want to receive a second dose but did
continue in the study
C4591001
1231
12313538 1 24 15SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT the subject did not agree to be vaccinated a second time,but
will continue in the study
C4591001
1231
12313621 2 42 26OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons
2 42 26OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons
C4591001
1231
12313651 1 22 14SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12313740 2 55 07NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject stops participating in the study due to emigration to
another country.
2 55 07NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject stops participating in the study due to emigration to
another country.
C4591001
1231
12313972 2 16 28SEP2020 VACCINATION DEATH DEATH
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 16 28SEP2020 FOLLOW -UP DEATH DEATH
C4591001
1231
12314003 2 30 12OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons
2 30 12OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons
C4591001
1231
12314060 1 57 20OCT2020 VACCINATION LOST TO FOLLOW -UP Subject did not reply to the registered letter. Contact is
considered lost.
1 57 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not reply to the registered letter. Contact is
considered lost.
C4591001
1231
12314120 1 20 14SEP20 20 VACCINATION WITHDRAWAL BY
SUBJECT did not agree that the Visit 1 swab result had not been
given
1 20 14SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT did not agree that the Visit 1 swab result had not been
given
C4591001
1231
12314189 1 20 14SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject misunderstood protocol and/or consent. Revokes
consent.
1 20 14SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT DISCONTINUED
C4591001
1231
12314301 1 21 15SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12314863 1 28 24SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12315246 1 20 17SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1231
12315608 1 20 19SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or microbiological diagnosis of COVID -
19
C4591001
1231
12315619 2 45 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons.
2 45 05NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons.
C4591001
1231
12315634 2 35 23OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons.
2 35 23OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the decision to stop participating is due to personal reasons.
C4591001
1231
12315672 1 22 21SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject in question decided to abandon the study for
personal reasons.
1 22 21SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject in question decided to abandon the study for
personal reasons.
C4591001
1232
12321105 1 64 28OCT2020 VACCINATION LOST TO FOLLOW -UP Unable to contact subject
1 64 28OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Unable to contact subject
C4591001
1232
12321432
28OCT2020 FOLLOW -UP PROTOCOL
DEVIATION Subject randomized in error
C4591001
1247
12471066 1 43 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Patient tested positive for COVID 19 and was symptomatic
prior to visit 2
C4591001
1247
12471135 1 22 21OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/CEREBRAL INFARCTION
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1248
12481026 1 23 20SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Withdrew due to time commitment. Mother is very sick
and she is taking care of her
1 23 20SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJEC T Subject withdrew prior to 2nd vaccination.
C4591001
1248
12481182
16SEP2020 FOLLOW -UP OTHER Randomized but not dosed.
C4591001
1248
12481214 1 26 15OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject stated he no longers want to to continue with study
per phone call
1 26 15OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject no longer wishes to continue
C4591001
1251
12511050 1 71 03NOV2020 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1251
12511236 1 23 30OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
1 23 30OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1254
12541074 2 38 28OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject requested to withdrawal consent
2 38 28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject wished to withdrawal consent.
C4591001
1260
12601121 1 20 30SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT patient withdrew from study prior to vaccine # 2
1 20 30SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawal of consent
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1264
12641195 1 23 14OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Excl. 1 No further st udy intervention but will remain in the
study to be evaluated for safety.
C4591001
1269
12691124 2 1 29SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent
2 1 29SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent
C4591001
1270
12701057 1 61 02NOV2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/PULMONARY EMBOLISM
C4591001
4444
44441152 1 22 12OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT The volunteer expresses his desire to withdraw consent to
participate in the study.
1 22 12OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The volunteer expresses his desire to withdraw consent to
participate in the study
C4591001
4444
44441495 1 24 15OCT2 020 VACCINATION WITHDRAWAL BY
SUBJECT for personal causes
1 24 15OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT for personal causes
C4591001
4444
44441792 1 9 01OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject, re -reads consent and decided it is not what she'd
understood. Decides to revoke consent.
1 9 01OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject rejects the terms of consent on a subsequent
rereading.
C4591001
4444
44442179 1 2 28SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject reports being sure that he received placebo and that
he participated to receive the vaccine.
1 2 28SE P2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject reports being sure that he received placebo and that
he participated to receive the vaccine.
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subject s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
Note: Data for subjects randomized on or after 10OCT2020 are included to comprehensively show all data reported but are subje ct to change with
additional follow -up.
Note: † = HIV -positive subject.
a. Relative Day (Rel Day) = date of withdrawal - date of last vaccination + 1. For a withdrawal that occurred before the date of the first study
vaccination, + 1 was not added to compute relative day.
b. MedDRA (v23.1) coding dictionary applied.
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (10:49) Source Data: adds Table Generation: 19NOV2020 (01:42)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2_unblinded/C4591001_IA_P3_2MPD2/adds_l001_withdraw_p3
090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)
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16.2.1.6 Listing of Subjects Withdrawn From the Study – Subjects Enrolled in Multiple Site s
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study
Phase Withdrawal
Reason Commentb
16-55 C4591001 1056
10561101 2 44 03NOV2020 FOLLOW -
UP PROTOCOL
DEVIATION SUBJECT WAS FOUND AS A DUPLICATE FROM
ANOTHER SITE IN CLOSE PROXIMITY.
a. Relative Day (Rel Day) = date of withdrawal - date of last vaccination + 1. For a withdrawal that occ urred before the date of the first study
vaccination, + 1 was not added to compute relative day.
b. MedDRA (v23.1) coding dictionary applied.
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (10:49) Source Data: adds Table Generation: 18NOV2020 (02:59)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2 unblinded/C4591001 IA P3 2MPD2/adds l001 wd menrol p3
090177e1959b2156\Final\Final On: 24-Nov-2020 13:47 (GMT)
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