Document text
BioNTech RNA
Pharmaceuticals GmbH
Confidential Interim Clinical Study Report
BNT162 -01 Page 1 of 1
Version: 2.0
Date: 27 NOV 2020
Participant data listings - Notes for the reader
To harmonize data reporting across the different BNT162 clinical studies, the following
terminology was harmonized in this interim clinical study report (CSR). The protocol,
Statistical Analysis Plan (SAP), and the CSR Section 14 tables/figures, and the Section 16
listings use the original BioNTech terminology:
BioNTech terminology in the protoc ol, SAP
and the CSR appendices Harmoni zed terminology used
in the interim CSR
Boost (dose) Dose 2
Cohort Dose group
Immunization Dosing
Immunized Dosed
Prime (dose) Dose 1
(Trial) Subject Participant
Trial Study
Vaccinated Dosed
Vaccination Dosing
Vaccine Investigational medicinal product
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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. Genera
l considerations
Gen
eral details:
The
programming is based on SAP fina
l version 4.0.
The
last digit of the numbering of tables, figures and listings indicates the vaccine: 1 for BNT162b1, 2 for BNT162a1, 3 for BNT16
2b2, 4 for BNT162c2 (single dose) and 5 for
BNT16
2c2 (prime/boost).
Some
tables presenting adverse events are
presented twice: once using the safety set and once using the safety boost set.
The
adverse events based on solicited reporting via subjects diaries are defined in the file BNT162 -01_
AEs_based_on_solicited_reporting_via_subjects_diaries_v2.0 MBx_SSt.
The
SDTM data used was received on 03NOV2020 in the folder SDTM_Group_BC_cutoff_20201023.
The
adverse events intensity was assessed on different scales:
- the 1
µg, 10 µg, 30 µg, 50 µg and 60 µg young cohorts was assessed on a 3 -poi
nt scale (mild, moder ate,
severe)
- the 3
µg and 20 µg young cohorts as well as the older cohorts were assessed on a 4 -poi
nt scale (mild, moderate, severe, potentially life -thre
atening).
Progra
mming details:
If a t
able which presents categories has any all zero rows, these row
s are suppressed.
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Page 2
FDA-CBER-2021-5683-0049415
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. Genera
l considerations
Gen
eral details:
The
programming is based on SAP fina
l version 4.0.
The
last digit of the numbering of tables, figures and listings indicates the vaccine: 1 for BNT162b1, 2 for BNT162a1, 3 for BNT16
2b2, 4 for BNT162c2 (single dose) and 5 for
BNT16
2c2 (prime/boost).
Some
tables presenting adverse events are
presented twice: once using the safety set and once using the safety boost set.
The
adverse events based on solicited reporting via subjects diaries are defined in the file BNT162 -01_
AEs_based_on_solicited_reporting_via_subjects_diaries_v2.0 MBx_SSt.
The
SDTM data used was received on 03NOV2020 in the folder SDTM_Group_BC_cutoff_20201023.
The
adverse events intensity was assessed on different scales:
- the 1
0 µg young cohort was assessed on a 3 -poi
nt scale (mild, moderate, severe)
- the 1
µg, 3 µg, 20 µ
g and 30 µg young cohorts as well as the older cohorts were assessed on a 4 -poi
nt scale (mild, moderate, severe, potentially life -thre
atening).
Progra
mming details:
If a t
able which presents categories has any all zero rows, these rows are suppresse d.
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