019736 S387 M5 c4591008 interim withdrawn subjects
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Appendix 7 List of Subject Data Listings 090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) Page 1 FDA-CBER-2021-5683-1075881 TABLE OF CONTENTS Listing 7.7.1 -Withdrawn Subjects ................................................................................................................................................................................................... 1 Listing 7.7.2 -Participant Reported Death ....................................................................................................................................................................................... 5 Listing 7.7.3 -Subjects Excluded from the Analyses ....................................................................................................................................................................... 6 Listing 7.7.4 -Demographic Data .................................................................................................................................................................................................... 19 Listing 7.7.5 -Medication/Treatment Data .................................................................................................................................................................................. 289 Listing 7.7.6 -Participant Reported Unplanned Hospitalization ............................................................................................................................................. 1614 Listing 7.7.7 -Participant Reported N on-Hospitalization Safety Events of Interest .............................................................................................................. 1618 090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) Page 2 FDA-CBER-2021-5683-1075882 Listing 7.7.1 Page 1of 4 BNT162b2 Protocol C4591008 Withdrawn Subjects PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, DS Generated from /dcri/ct/hero_together/lists/l_withdrawal.sas on 24MAY2021 12:45 Page 1of 1689 Subject ID Age/Sex/Race Date of Study Exit Reason for Non -Completion Other, Specify C4591008 -1045237312 42// 2021 -03-27 Withdrawal by Subject C4591008 -1121954368 32/F/WHITE 2021 -04-15 Withdrawal by Subject C4591008 -1154759744 72/F/WHITE 2021 -04-27 Withdrawal by Subject C4591008 -1156407872 31// 2021 -03-26 Withdrawal by Subject C4591008 -1205435456 40// 2021 -04-22 Withdrawal by Subject C4591008 -1359381056 39// 2021 -04-30 Withdrawal by Subject C4591008 -1376526400 30// 2021 -04-15 Withdrawal by Subject C4591008 -1484560960 38// 2021 -03-29 Withdrawal by Subject C4591008 -1550476352 51/F/WHITE 2021 -03-04 Withdrawal by Subject C4591008 -1649581120 37/M/UNKNOWN 2021 -03-24 Withdrawal by Subject C4591008 -1780267584 22/F/WHITE 2021 -03-22 Withdrawal by Subject C4591008 -1822506048 54/F/WHITE 2021 -02-11 Withdrawal by Subject C4591008 -1848109632 37/M/WHITE 2021 -04-29 Withdrawal by Subject C4591008 -1998621248 27// 2020 -12-28 Withdrawal by Subject C4591008 -2207048768 40/F/BLACK OR AFRICAN AMERICAN2021 -02-26 Withdrawal by Subject C4591008 -2395812416 42// 2021 -01-28 Withdrawal by Subject C4591008 -2586939968 26// 2021 -04-12 Withdrawal by Subject C4591008 -2760237632 54// 2021 -03-13 Withdrawal by Subject C4591008 -2925244992 67// 2021 -02-03 Withdrawal by Subject C4591008 -3085109312 43// 2021 -04-07 Withdrawal by Subject C4591008 -3111736384 73/M/WHITE 2021 -03-25 Withdrawal by Subject C4591008 -3183032384 56// 2021 -03-26 Withdrawal by Subject C4591008 -3282734656 69/F/WHITE 2021 -05-06 Withdrawal by Subject C4591008 -3335842368 41// 2021 -05-03 Withdrawal by Subject C4591008 -3387831872 35/F/WHITE 2021 -04-09 Withdrawal by Subject C4591008 -3507592256 29/F/WHITE 2021 -04-19 Withdrawal by Subject C4591008 -3531886656 34/F/WHITE 2021 -04-12 Withdrawal by Subject C4591008 -3671900736 35/F/WHITE 2021 -05-03 Withdrawal by Subject 090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) Page 3 FDA-CBER-2021-5683-1075883 Listing 7.7.1 Page 2of 4 BNT162b2 Protocol C4591008 Withdrawn Subjects PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, DS Generated from /dcri/ct/hero_together/lists/l_withdrawal.sas on 24MAY2021 12:45 Page 2of 1689 Subject ID Age/Sex/Race Date of Study Exit Reason for Non -Completion Other, Specify C4591008 -3731146304 38// 2021 -03-22 Withdrawal by Subject C4591008 -3972789824 34// 2021 -03-12 Withdrawal by Subject C4591008 -3997816384 61// 2021 -03-31 Withdrawal by Subject C4591008 -4080944192 52// 2021 -02-25 Withdrawal by Subject C4591008 -4105590336 30// 2021 -05-09 Withdrawal by Subject C4591008 -4442393152 35// 2021 -03-22 Withdrawal by Subject C4591008 -4445236800 28/M/BLACK OR AFRICAN AMERICAN2021 -03-30 Withdrawal by Subject C4591008 -4460383808 25/F/BLACK OR AFRICAN AMERICAN2021 -04-02 Withdrawal by Subject C4591008 -4471943232 49/F/ASIAN 2021 -04-03 Withdrawal by Subject C4591008 -4631023168 30// 2021 -02-22 Withdrawal by Subject C4591008 -4649785408 60// 2021 -01-19 Withdrawal by Subject C4591008 -4816193600 36// 2021 -04-26 Withdrawal by Subject C4591008 -4856378432 45// 2021 -01-23 Withdrawal by Subject C4591008 -4973241408 59/F/WHITE 2021 -04-19 Withdrawal by Subject C4591008 -5033103936 31/F/WHITE 2021 -01-29 Withdrawal by Subject C4591008 -5039773760 44// 2021 -01-23 Withdrawal by Subject C4591008 -5059783232 47/F/WHITE 2021 -03-27 Withdrawal by Subject C4591008 -5522132032 44/F/WHITE 2021 -05-02 Withdrawal by Subject C4591008 -5673267776 51/F/WHITE 2021 -02-22 Withdrawal by Subject C4591008 -5884485184 45// 2021 -02-28 Withdrawal by Subject C4591008 -5913742912 64// 2021 -04-28 Withdrawal by Subject C4591008 -6085711936 63// 2021 -02-22 Withdrawal by Subject C4591008 -6355630656 45// 2021 -02-22 Withdrawal by Subject C4591008 -6424860736 40// 2021 -05-04 Withdrawal by Subject C4591008 -6435536448 30// 2021 -03-03 Withdrawal by Subject C4591008 -6561028160 36// 2021 -03-16 Withdrawal by Subject C4591008 -6571033152 37// 2021 -03-09 Withdrawal by Subject 090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) Page 4 FDA-CBER-2021-5683-1075884 Listing 7.7.1 Page 3of 4 BNT162b2 Protocol C4591008 Withdrawn Subjects PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, DS Generated from /dcri/ct/hero_together/lists/l_withdrawal.sas on 24MAY2021 12:45 Page 3of 1689 Subject ID Age/Sex/Race Date of Study Exit Reason for Non -Completion Other, Specify C4591008 -6625382464 51// 2021 -04-03 Withdrawal by Subject C4591008 -6695515200 23// 2021 -01-21 Other duplicate enrollment C4591008 -6872706624 73/M/WHITE 2021 -02-05 Death C4591008 -6885793856 20// 2021 -04-08 Withdrawal by Subject C4591008 -6932550208 61// 2021 -01-22 Withdrawal by Subject C4591008 -6989774912 37// 2021 -01-09 Withdrawal by Subject C4591008 -7152443968 55/F/WHITE 2021 -03-29 Withdrawal by Subject C4591008 -7231658560 66// 2021 -01-28 Withdrawal by Subject C4591008 -7271517760 54/M/WHITE 2021 -03-04 Death C4591008 -7425883200 68// 2021 -05-03 Withdrawal by Subject C4591008 -7427544128 56// 2021 -03-10 Withdrawal by Subject C4591008 -7484650048 62// 2021 -02-11 Withdrawal by Subject C4591008 -7643584064 66/F/WHITE 2021 -04-20 Withdrawal by Subject C4591008 -7672349760 48/M/ASIAN 2021 -03-22 Withdrawal by Subject C4591008 -7677371456 61// 2021 -03-29 Withdrawal by Subject C4591008 -7914419776 47/F/WHITE 2021 -04-26 Withdrawal by Subject C4591008 -8009032768 60// 2021 -01-20 Withdrawal by Subject C4591008 -8047590976 54/F/WHITE 2021 -03-29 Withdrawal by Subject C4591008 -8182982720 37/F/WHITE 2021 -02-08 Withdrawal by Subject C4591008 -8192535104 49// 2021 -04-14 Withdrawal by Subject C4591008 -8521512000 59// 2021 -04-27 Withdrawal by Subject C4591008 -8644293696 62/F/WHITE 2021 -03-22 Withdrawal by Subject C4591008 -8722871360 27/F/WHITE 2021 -04-20 Withdrawal by Subject C4591008 -8752952384 59/M/WHITE 2021 -04-01 Withdrawal by Subject C4591008 -8790261312 60/M/ASIAN 2021 -04-17 Withdrawal by Subject C4591008 -9119995968 60/F/WHITE 2021 -01-15 Withdrawal by Subject C4591008 -9186163776 35// 2021 -02-22 Withdrawal by Subject C4591008 -9214424640 28// 2021 -03-24 Withdrawal by Subject C4591008 -9303511104 43// 2021 -01-15 Withdrawal by Subject 090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) Page 5 FDA-CBER-2021-5683-1075885 Listing 7.7.1 Page 4of 4 BNT162b2 Protocol C4591008 Withdrawn Subjects PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, DS Generated from /dcri/ct/hero_together/lists/l_withdrawal.sas on 24MAY2021 12:45 Page 4of 1689 Subject ID Age/Sex/Race Date of Study Exit Reason for Non -Completion Other, Specify C4591008 -9373158976 54// 2021 -02-27 Withdrawal by Subject C4591008 -9408807488 26/M/WHITE 2021 -04-13 Withdrawal by Subject C4591008 -9417470016 43/F/WHITE 2021 -04-04 Withdrawal by Subject C4591008 -9448242240 32// 2021 -04-13 Withdrawal by Subject C4591008 -9572432960 31/F/WHITE 2021 -04-26 Withdrawal by Subject C4591008 -9612212800 51// 2021 -01-15 Withdrawal by Subject C4591008 -9680187968 50/M/WHITE 2021 -04-30 Withdrawal by Subject C4591008 -9767999040 66/F/WHITE 2021 -03-16 Withdrawal by Subject C4591008 -9810542656 35/F/WHITE 2021 -04-15 Withdrawal by Subject 090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) Page 6 FDA-CBER-2021-5683-1075886