125742 S1 M5 5351 bnt162 01 interim3 excluded patients
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Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.1 -4.2-1: Lis ting of subjects excluded from Safety boost set - BNT 162b1 Safety set Dose g roup Subj ect num ber Reaso n for exclusion Date of f irst info rmed consent Date o f scre ening 10 µg You nger 10010 Subj ect did not receive two doses of IMP 22APR20 20 22APR20 20 20 µg You nger 10182 Subj ect did not receive two doses of IMP 09J UL2020 09J UL2020 50 µg You nger 10050 Subj ect did not receive two dos es of IMP 05M AY2020 05M AY2020 60 µg You nger 10066 Subj ect did not receive two doses of IMP 08M AY2020 08M AY2020 10075 Subj ect did not receive two doses of IMP 11M AY2020 11M AY2020 10076 Subj ect did not receive two doses of IMP 11M AY2020 11M AY2020 10078 Subj ect did not receive two doses of IMP 11M AY2020 11M AY2020 10083 Subj ect did not receive two doses of IMP 12M AY2020 12M AY2020 10084 Subj ect did not receive two doses of IMP 12M AY2020 12M AY2020 10085 Subj ect did not receive two doses of IMP 12M AY2020 12M AY2020 10089 Subj ect did not receive two doses of IMP 12M AY2020 12M AY2020 10093 Subj ect did not receive two doses of IMP 12M AY2020 12M AY2020 10096 Subj ect did not receive two doses of IMP 12M AY2020 12M AY2020 10103 Subj ect did not rece ive two doses of IMP 14M AY2020 14M AY2020 10104 Subj ect did not receive two doses of IMP 14M AY2020 14M AY2020 20 µg Older 20242 Subj ect did not receive two doses of IMP 28AUG 2020 28AUG 2020 IMP = inv estigational med icinal prod uct. Progra m: Lba se_Disp_4_2.sas (Page 1 of 1) 090177e1959f775e\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 1 FDA-CBER-2021-5683-0049449 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.1 -4.3-1: Lis ting of subjects excluded from Immunogenicity set - BNT 162b1 Safety set Dose g roup Subj ect num ber Reaso n for exclusion Date o f first info rmed consent Date o f scre ening 30 µg Older 10350 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10351 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10352 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10353 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10358 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10360 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10361 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10362 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10363 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10364 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10365 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 10366 Subj ect did not receive one dose of IMP or did not have one post -bas eline immunogenicity assessment 14SEP2 020 14SEP2 020 IMP = inv estigational med icinal prod uct. Progra m: Lba se_Disp_4_2.sas (Page 1 of 1) 090177e1959f775e\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 2 FDA-CBER-2021-5683-0049450 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b2 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.1 -4.2-3: Lis ting of subjec ts excluded from Safety boost set - BNT 162b2 Safety set Dose g roup Subj ect num ber Reaso n for exclusion Date o f first info rmed consent Date o f scre ening 1 µg Y ounger 20160 Subj ect did not receive two doses of IMP 15J UN2020 15J UN2020 10 µg You nger 20116 Subj ect did not receive two doses of IMP 20M AY2020 20M AY2020 IMP = inv estigational med icinal prod uct. Progra m: Lba se_Disp_4_2.sas (Page 1 of 1) 090177e1959f775f\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 3 FDA-CBER-2021-5683-0049451 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b2 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on cl ean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.1 -4.3-3: Lis ting of subjects excluded from Immunogenicity set - BNT 162b2 Safety set No su bjects were excluded from Immunogenicity set. 090177e1959f775f\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 4 FDA-CBER-2021-5683-0049452