125742 S1 M5 5351 bnt162 01 interim3 discontinued 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 received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.1 -3-1: Listing of subjects with premature discontinuation - BNT 162b1 Safety set Dose g roup Subj ect number Date o f last vis it/contact Date o f premature termi nation Mai n reason for premature termination Epi/ Pandemic rela ted 10 µg Younger 10010 22M AY2020 19M AY2020 Adve rse Event No 20 µg Younger 10178 09SEP2 020 09SEP2 020 Othe r (private reason) No 10182 06O CT2020 23J UL2020 Wit hdrawal By Subject No 50 µg Younger 10050 03J UN2020 03J UN2020 Othe r (due to private reason.) No Progra m: Lba se_Disp_3.sas (Page 1 of 1) 090177e1959f772d\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 1 FDA-CBER-2021-5683-0049417 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 rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.1 -3-3: Listing of subjects with premature discontinuation - BNT 162b2 Safety set Dose g roup Subj ect number Date o f last vis it/contact Date o f premature termi nation Mai n reason for premature termination Epi/ Pandemic rela ted 1 µg Y ounger 20160 31J UL2020 30J UL2020 Wit hdrawal By Subject No 10 µg Younger 20116 04AUG 2020 16J UL2020 Adve rse Event No Progra m: Lba se_Disp_3.sas (Page 1 of 1) 090177e1959f772e\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 2 FDA-CBER-2021-5683-0049418