125742_S1_M5_5351_c4591001-fa-interim-discontinued-patients.pdf

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

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.

1

37 02NOV2020 VACCINATION

WITHDRAWAL BY SUBJECT

Due to a psychiatric condition, subject expresses his desire to withdraw consent

1

37 02NOV2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Due to a psychiatric condition, subject expresses his desire to withdraw consent

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

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

C4591001 4444 44442293

C4591001 4444 44442319

>55

Dose Rel Withdrawal No. Daya Date

C4591001 1005 10051214

NO LONGER MEETS DISCONTINUATION AS SUBJECT TESTED POSITIVE ELIGIBILITY CRITERIA FOR COVID 19

FDA-CBER-2021-5683-0129069

Page 80

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

C4591001 1007 10071347

1

22 05NOV2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

subject did not meet inclusion criteria #3

C4591001 1008 10081639

1

6

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

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

06AUG2020

SCREENING

OTHER

SUBJECT WAS ALREADY RANDOMIZED BUT DID NOT MEET CRITERIA FOR VACCINATION. SUBJECT IS DISCONTINUTED.

PROTOCOL DEVIATION

SUBJECT DID NOT MEET EXCLUSION #5 BUT WAS ALREADY RANDOMIZED INTO STUDY. DID NO RECEIVE VACCINATION.

C4591001 1009 10091157

C4591001 1013 10131097

24OCT2020 VACCINATION

06AUG2020 FOLLOW-UP

FDA-CBER-2021-5683-0129070

Page 81

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1013 10131123

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

70 09NOV2020 VACCINATION LOST TO FOLLOW-UP

UNKNOWN

2

70 09NOV2020 FOLLOW-UP

UNKNOWN

1

23

08SEP2020 VACCINATION PHYSICIAN DECISION

PHYSICIAN DECISION

1

23

08SEP2020

FOLLOW-UP

PHYSICIAN DECISION

PHYSICIAN DECISION

2

29 29OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT FROM THE STUDY.

13AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject withdrew consent after being randomized.

50 30OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

Subject was still enrolled in another study while being enrolled in this one.

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

OTHER

IP was quarantined after patient was randomized

C4591001 1013 10131192 C4591001 1013 10131509 C4591001 1019 10191033 C4591001 1019 10191201 C4591001 1019 10191300

1

FOLLOW-UP

LOST TO FOLLOW-UP

FDA-CBER-2021-5683-0129071

Page 82

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1024 10241077

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

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

WITHDRAWAL BY SUBJECT

patient withdrew consent

C4591001 1024 10241130†

1

9

28OCT2020 VACCINATION

NO LONGER MEETS ELIGIBILITY CRITERIA

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

FOLLOW-UP

LOST TO FOLLOW-UP Site attempted to contact subject on multiple occasions and certified letter was sent.

C4591001 1037 10371057

24AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT NOT WILLING TO ATTEND VISITS AFTER RANDOMIZATION WAS COMPLETED

C4591001 1037 10371117

18SEP2020

WITHDRAWAL BY SUBJECT

Subject did not want to wait to receive Flu vaccine

NO LONGER MEETS ELIGIBILITY CRITERIA

Due to previous medical condition, patient now requires treatment with corticosteroid.

FOLLOW-UP

C4591001 1039 10391019

1

24

C4591001 1042 10421010

1

21 19AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

withdrew consent

1

21 19AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject withdrew consent

WITHDRAWAL BY SUBJECT

subject withdrew consent to participate

C4591001 1044 10441113

16SEP2020 VACCINATION

11SEP2020

FOLLOW-UP

FDA-CBER-2021-5683-0129072

Page 83

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1046 10461259

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

22 05OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject Decision to With Draw

1

22 05OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject Decision

2

11

18SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject withdrew conset

2

11

18SEP2020

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

WITHDRAWAL BY SUBJECT

withdrawl by patient

1

26

25SEP2020 VACCINATION LOST TO FOLLOW-UP

1

26

25SEP2020

C4591001 1047 10471011

C4591001 1052 10521062

FOLLOW-UP

FOLLOW-UP

n/a

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

23SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/DIZZINESS

C4591001 1054 10541186

1

1

FDA-CBER-2021-5683-0129073

Page 84

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya 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

28AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Pt. referred she did not want to continue in the study.

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.

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

1

25

25SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject expressed his desire to withdrew his participation in the trial.

1

25

25SEP2020

WITHDRAWAL BY SUBJECT

Subject expressed his desire to withdrew his participation in the trial.

C4591001 1056 10561078 C4591001 1056 10561079

C4591001 1056 10561083

C4591001 1056 10561120

FOLLOW-UP

FDA-CBER-2021-5683-0129074

Page 85

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1056 10561123

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

24

24SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject states he doesn't want to continue in the study.

1

24

24SEP2020

WITHDRAWAL BY SUBJECT

Subject states he doesn't want to continue in the study.

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.

1

20 06OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT STATED HE DOES NOT WANT TO CONTINUE PARTICIPATING IN THE TRIAL.

1

20 06OCT2020

WITHDRAWAL BY SUBJECT

SUBJECT STATED HE DOES NOT WANT TO CONTINUE PARTICIPATING IN THE TRIAL.

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.

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

WITHDRAWAL BY SUBJECT

discontinued/refused vaccination #2

C4591001 1066 10661350

1

16 03NOV2020 VACCINATION

DEATH

DEATH

C4591001 1056 10561275

C4591001 1056 10561276

C4591001 1056 10561298

C4591001 1056 10561371

FOLLOW-UP

FOLLOW-UP

15SEP2020 VACCINATION

FDA-CBER-2021-5683-0129075

Page 86

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

1

16 03NOV2020 FOLLOW-UP

DEATH

DEATH

1

12 23AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/CORONARY ARTERY DISEASE

1

17 28AUG2020 FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT

1

13 31AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

1

13 31AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

1

31 15OCT2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/ALCOHOL POISONING

1

31 15OCT2020

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

WITHDRAWAL BY SUBJECT

withdrawal by subject

1

38

11SEP2020 VACCINATION LOST TO FOLLOW-UP

Subject is lost to follow up

1

38

11SEP2020

LOST TO FOLLOW-UP

subject is lost to follow up

1

50 07OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Patient did not wish to recieve Vax2 but agreed to continue in study.

C4591001 1071 10711023 C4591001 1071 10711063

C4591001 1071 10711169

C4591001 1079 10791057 C4591001 1080 10801064

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

FDA-CBER-2021-5683-0129076

Page 87

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1082 10821029

Dose Rel Withdrawal No. Daya Date

Withdrawal Reason

Commentb

2

1

25AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject completed vaccination 2 but did not complete the 1 month follow-up.

2

29

22SEP2020

WITHDRAWAL BY SUBJECT

Subject completed vaccination 2 but did not complete the 1 month follow-up.

06AUG2020 FOLLOW-UP

PROTOCOL DEVIATION

Subject was randomized but did not receive study vaccination. Subject left site prior to vaccination

C4591001 1082 10821062 C4591001 1082 10821126

Study Phase

FOLLOW-UP

1

1

21AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent prior to receiving the second vaccination.

1

33

22SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject did not complete follow-up period.

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

ADVERSE 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

2

53 26OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject withdrew from trial

2

53 26OCT2020

WITHDRAWAL BY SUBJECT

subject withdrew from trial

C4591001 1082 10821164

C4591001 1084 10841184

FOLLOW-UP

FDA-CBER-2021-5683-0129077

Page 88

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

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

Subject

C4591001 1087 10871080

C4591001 1087 10871121 C4591001 1087 10871211

C4591001 1087 10871228

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.

1

22

09SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/GASTROINTESTINAL HAEMORRHAGE

1

22

09SEP2020

FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT

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.

1

22

16SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/CARDIAC FAILURE CONGESTIVE

1

22

16SEP2020

FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT

11SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Pt withdrew consent noting it would be very difficult to ever collect blood from her.

23 13OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Pt reports she has a lot going on in her personal life & wishes to discontinue study.

C4591001 1087 10871434 C4591001 1087 10871505

Commentb

1

FDA-CBER-2021-5683-0129078

Page 89

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

1

Withdrawal Reason

23 13OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Pt reports she has a lot going on in her life & wishes to discontinue study.

22SEP2020

FOLLOW-UP

PROTOCOL DEVIATION

Subject randomized in error

C4591001 1087 10871512 C4591001 1089 10891098

C4591001 1089 10891344

C4591001 1090 10901141

C4591001 1090 10901415

2

30

29SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject came by office an not longer wanted to do trial. returned diary

2

30

29SEP2020

WITHDRAWAL BY SUBJECT

subject came by office an not longer wanted to do trial. returned diary

1

35 26OCT2020 VACCINATION LOST TO FOLLOW-UP

1

35 26OCT2020

2

9

2

9

1

C4591001 1091 10911092 C4591001 1092 10921191

Commentb

Study Phase

FOLLOW-UP

FOLLOW-UP

contacts attempted and certified letter sent

LOST TO FOLLOW-UP

several attempts have been made to contact subject and certified letter sent. LTFU

08SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

pt is moving away and not able to come to visits any longer. He talked to PI

08SEP2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

subject moved away

58 13NOV2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/HEADACHE

10AUG2020 FOLLOW-UP

OTHER

subject randomized with incorrect subject demographics, was not dosed, then withdrawn and rescreened

1

35 20OCT2020 VACCINATION LOST TO FOLLOW-UP

1

35 20OCT2020

FOLLOW-UP

LOST TO FOLLOW-UP

Subject did not show for visit 2 unable to make contact with subject Subject did not return for V2 FDA-CBER-2021-5683-0129079

Page 90

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya 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

1

32 16OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent

1

32 16OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject withdrew consent

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

C4591001 1094 10941130

C4591001 1095 10951102

FDA-CBER-2021-5683-0129080

Page 91

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

C4591001 1096 10961082

C4591001 1096 10961086 C4591001 1096 10961160

Dose Rel Withdrawal No. Daya Date

C4591001 1097 10971033

C4591001 1098 10981026

Withdrawal Reason

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Commentb

1

28

1

54 12OCT2020 VACCINATION LOST TO FOLLOW-UP

1

54 12OCT2020

1

52 11OCT2020 VACCINATION LOST TO FOLLOW-UP

LTFU, unresponsive to contact attempts

1

52 11OCT2020

LTFU, unresponsive to contact attempts

1

47 13OCT2020 VACCINATION LOST TO FOLLOW-UP

unable to reach subject despite numerous attempt and certified letter was sent

1

47 13OCT2020

LOST TO FOLLOW-UP

unable to reach subject despite numerous attempt and certified letter was sent

17AUG2020 FOLLOW-UP

PROTOCOL DEVIATION

Randomized in error.

C4591001 1097 10971003

14SEP2020

Study Phase

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

LOST TO FOLLOW-UP

withdrew consent LTFU, unresponsive to contact attempts

site unable to contact subject after multiple attempts and certified letter sent

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.

2

33 26OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject no longer wanted to participate in the study.

2

33 26OCT2020

WITHDRAWAL BY SUBJECT

no reason given.

FOLLOW-UP

FDA-CBER-2021-5683-0129081

Page 92

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1098 10981030

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

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.

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

WITHDRAWAL BY SUBJECT

subject withdrew the consent , as he was will be not able to be compliant in the future.

2

45 07OCT2020 VACCINATION LOST TO FOLLOW-UP

Subject never return for visit, returned call or returned certified letter.

2

45 07OCT2020

LOST TO FOLLOW-UP

Subject never return for visit, returned call or returned certified letter.

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.

1

25

09SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT CALLED WHEN V-2 WAS MISSED AND SHE STATED NO LONGER WANTING TO PARTICIPATE.

C4591001 1098 10981130

C4591001 1109 11091093

C4591001 1109 11091095

C4591001 1109 11091248

FOLLOW-UP

FOLLOW-UP

FDA-CBER-2021-5683-0129082

Page 93

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

C4591001 1109 11091253

Dose Rel Withdrawal No. Daya Date

C4591001 1109 11091475

Withdrawal Reason

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Commentb

1

25

2

46 20OCT2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT NEVER RESPONDED TO MULTIPLE CALLS AND CERTIFIED LETTER SENT

2

46 20OCT2020

LOST TO FOLLOW-UP

SUBJECT NEVER RESPONDED TO MULTIPLE CALLS AND CERTIFIED LETTER SENT

PROTOCOL DEVIATION

Randomized in error

C4591001 1109 11091259

09SEP2020

Study Phase

FOLLOW-UP

16AUG2020 FOLLOW-UP

SUBJECT CALLED WHEN V-2 WAS MISSED AND SHE STATED NO LONGER WANTING TO PARTICIPATE.

1

51 29OCT2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT NEVER RESPONDED TO CALLS OR CERTIFIED LETTER

1

51 29OCT2020

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

WITHDRAWAL BY SUBJECT

Subject withdrawal

1

50

22SEP2020 VACCINATION LOST TO FOLLOW-UP

1

50

22SEP2020

1

2

12AUG2020 VACCINATION

C4591001 1112 11121052 C4591001 1112 11121118

FOLLOW-UP

FOLLOW-UP

FOLLOW-UP

unable to reach subject for follow up visits

LOST TO FOLLOW-UP

unable to reach subject to return for follow up visits

ADVERSE EVENT

ADVERSE EVENT/TACHYCARDIA

FDA-CBER-2021-5683-0129083

Page 94

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1112 11121134

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

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

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

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 1112 11121255

C4591001 1112 11121337

C4591001 1116 11161253

1

11

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 times

1

50 07OCT2020

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject missed visit 2 appointment and has not returned any contact attempts from the site.

1

54 12OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Refused vaccination 2, consents to follow-up study procedures (blood draws, diary, phone calls)

C4591001 1118 11181072

28SEP2020 VACCINATION

NO LONGER MEETS Patient was symptomatic and tested positive for COVID-19 ELIGIBILITY CRITERIA between Vaccine 1 and Vaccine 2

FDA-CBER-2021-5683-0129084

Page 95

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1118 11181090

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

2

21 05OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

withdrew consent

2

21 05OCT2020

WITHDRAWAL BY SUBJECT

WITHDREW CONSENT

1

66 09OCT2020 VACCINATION LOST TO FOLLOW-UP

1

66 09OCT2020

C4591001 1120 11201073

1

C4591001 1120 11201127

C4591001 1120 11201066

FOLLOW-UP

LOST TO FOLLOW-UP

Subject phone disconnected emergency contact can't be reached and certified letter sent no response

24 28AUG2020 VACCINATION

WITHDRAWAL BY SUBJECT

subject refused vax 2. will follow subject throughout duration of study

1

4

14AUG2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/DIARRHOEA

1

4

14AUG2020 FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT

2

37 09OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject stated he wanted to withdraw

2

37 09OCT2020

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

ADVERSE EVENT

ADVERSE EVENT/DEPRESSION

C4591001 1125 11251211

1

53 02NOV2020 VACCINATION

OTHER

did not receive 2nd vax

C4591001 1120 11201182

FOLLOW-UP

UNABLE TO BE REACHED FOR VISIT 2

FOLLOW-UP

29OCT2020 VACCINATION

FDA-CBER-2021-5683-0129085

Page 96

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1125 11251222

Dose Rel Withdrawal No. Daya Date 9

Withdrawal Reason

Commentb

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

2

33 19OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT

2

33 19OCT2020

WITHDRAWAL BY SUBJECT

SUBJECT WITHDREW CONSENT TO PROCEED IN STUDY

C4591001 1128 11281212

1

Study Phase

FOLLOW-UP

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

2

49 15OCT2020 VACCINATION

WITHDRAWAL BY SUBJECT

Subject withdrew consent

2

49 15OCT2020

WITHDRAWAL BY SUBJECT

Subject withdrew consent

2

34 07OCT2020 VACCINATION PHYSICIAN DECISION

PHYSICIAN DECISION

2

34 07OCT2020

PHYSICIAN DECISION

C4591001 1133 11331080

C4591001 1133 11331168

FOLLOW-UP

FOLLOW-UP

PHYSICIAN DECISION

FDA-CBER-2021-5683-0129086

Page 97

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1133 11331174

Dose Rel Withdrawal No. Daya Date 2

57 30OCT2020

C4591001 1133 11331197 C4591001 1133 11331426

C4591001 1133 11331472 C4591001 1133 11331481

Study Phase

Withdrawal Reason

FOLLOW-UP

WITHDRAWAL BY SUBJECT

19AUG2020 FOLLOW-UP

Commentb Subject refuse to be compliant with diary. He is not longer interesting in study.

NO LONGER MEETS subject received shingle vaccine on 7/22/2020, subject was ELIGIBILITY CRITERIA not dosed

1

34 12OCT2020 VACCINATION LOST TO FOLLOW-UP

SUBJECT IS LTF. CERTIFIED LETTER SENT 12/OCT/20

1

34 12OCT2020

SUBJECT IS LTF. CERTIFIED LETTER SENT 12/OCT/20

1

33 20OCT2020 VACCINATION LOST TO FOLLOW-UP

Unable to contact subject

1

33 20OCT2020

LOST TO FOLLOW-UP

Unable to contact subject

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

20AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject withdrew consent

22SEP2020

C4591001 1134 11341130

FOLLOW-UP

FOLLOW-UP

LOST TO FOLLOW-UP

C4591001 1135 11351019

2

29

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

WITHDRAWAL BY SUBJECT

Subject no longer wanted to participate after experiencing a spontaneous coronary artery dissection

17SEP2020

FOLLOW-UP

FDA-CBER-2021-5683-0129087

Page 98

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject C4591001 1140 11401003

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

Commentb

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

1

50

22SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/URTICARIA

1

50

22SEP2020

FOLLOW-UP

ADVERSE EVENT

ADVERSE EVENT

1

19

04SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/ABDOMINAL PAIN

1

19

04SEP2020 VACCINATION

ADVERSE EVENT

ADVERSE EVENT/NIGHT SWEATS

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

1

47 06OCT2020 VACCINATION

C4591001 1140 11401035 C4591001 1142 11421111 C4591001 1145 11451041

C4591001 1149 11491117

LOST TO FOLLOW-UP Subject is non responsive. Certified letter sent 30OCT2020. WITHDRAWAL BY SUBJECT

Subject withdrew consent via phone call

FDA-CBER-2021-5683-0129088

Page 99

16.2.1.4 Listing of Subjects Withdrawn From the Study – All Subjects

090177e1959b2157\Final\Final On: 24-Nov-2020 13:47 (GMT)

Age Group (Years)

Subject

Dose Rel Withdrawal No. Daya Date

Study Phase

Withdrawal Reason

FOLLOW-UP

WITHDRAWAL BY SUBJECT

Commentb

1

47 06OCT2020

1

71 30OCT2020 VACCINATION LOST TO FOLLOW-UP

1

71 30OCT2020

1

61 09NOV2020 VACCINATION LOST TO FOLLOW-UP Subject is non responsive. Certified letter sent 30OCT2020.

1

61 09NOV2020 FOLLOW-UP

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

17AUG2020 FOLLOW-UP

WITHDRAWAL BY SUBJECT

Subject could not make future study appointments

C4591001 1149 11491126 C4591001 1149 11491224

C4591001 1157 11571028 C4591001 1157 11571131

FOLLOW-UP

LOST TO FOLLOW-UP

Subject withdrew consent via phone conversation. Subject was mailed certified letter 30OCT2020.

Certified Letter sent 30OCT2020

LOST TO FOLLOW-UP Subject is non responsive. Certified letter sent 30OCT2020.

1

23

24SEP2020 VACCINATION

WITHDRAWAL BY SUBJECT

Voluntary withdrawal not due to an adverse event

1

23

24SEP2020

WITHDRAWAL BY SUBJECT

Voluntary withdrawal not due to an AE or SAE

FOLLOW-UP

FDA-CBER-2021-5683-0129089

Page 100