125742 S1 M5 c4591001 T S summary differences csr vs update
Document text
Table 1: Summary of Differences Between CSR Reactogenicity Data and Updated Reactogenicity Data for Study C4591001 –
Phase 2/3 Subjects 16- 55 Years of Age – Safety Population ................................................................................................................. 2
Table 2: Summary of Differences Between CSR Reactogenicity Data and Updated Reactogenicity Data for Study C4591001 – Phase 2/3 Subjects >55 Years of Age – Safety Population .................................................................................................................... 3
090177e196f19a0a\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0023995
Summary of Differences Between CSR Reactogenicity Data and Updated Reactogenicity Data for Study C4591001 – Phase 2/3
Subjects 16 -55 Years of Age – Safety Population
Vaccine Group (as Administered )
BNT162b2 (30 μg) Placebo
Number of total reactogenicity records 447303 447749
Number (%) records affecteda 536 (0.12) 140 (0.03)
Number of subjects 2923 2941
Number (%) subjects with any records affected 109 (3.73) 48 (1.63)
Maximum difference (updated data -CSR data) across any local reaction term of the percentage
of subjects with a local reaction within 7 days of first vaccinationb 0.1 0.2
Maximum difference (updated data -CSR data) across any local reaction term of the percentage
of subjects with a local reaction within 7 days of second vaccinationb 0.1 0.1
Maximum difference (updated data -CSR data) across any systemic event term of the
percentage of subjects with a systemic event within 7 days of first vaccinationb 0.1 0.0
Maximum difference (updated data -CSR data) across any systemic event term of the
percentage of subjects with a systemic event within 7 days of second vaccinationb 0.3 0.2
Maximum difference (updated data -CSR data) across any local reaction term of the duration in
mean days following first vaccinationb 0.01 0.0
Maximum difference (updated data -CSR data) across any local reaction term of the duration in
mean days following second vaccinationb 0.0 0.0
Maximum difference (updated data -CSR data) across any systemic event term of the duration
in mean days following first vaccinationb 0.01 0.0
Maximum difference (updated data -CSR data) across any systemic event term of the duration
in mean days following second vaccinationb 0.02 0.01
Difference (updated data -CSR data) of number of subjects with a duration of a ny local reaction
>7 days following either vaccination 1 0
Difference (updated data -CSR data) of number of subjects with a duration of a ny systemic
event >7 days following either vaccination 5 3
Abbreviations: CRF = case report form; CSR = clinical study report
Note: CSR data is data reported in the CSR that was entered into the electronic diary by the subject and symptom resolved page by the investigator. Updated data
is the CSR data and the reactogenicity data entered in the AE log CRF page by the investigator.
a. An affected record is any record that changed during the reactogenicity update.
b. Maximum difference is displayed as a percentage and is for reactogenicity data.
090177e196f19a0a\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0023996
Summary of Differences Between CSR Reactogenicity Data and Updated Reactogenicity Data for Study C4591001 – Phase 2/3
Subjects >55 Years of Age – Safety Population
Vaccine Group (as Administered)
BNT162b2 (30 μg) Placebo
Number of total reactogenicity records 311695 307249
Number (%) records affecteda 207 (0.07) 79 (0.03)
Number of subjects 2025 2007
Number (%) subjects with any records affected 49 (2.42) 22 (1.10)
Maximum difference (updated data -CSR data) across any local reaction term of the percentage
of subjects with a local reaction within 7 days of first vaccinationb 0.1 0.2
Maximum difference (updated data -CSR data) across any local reaction term of the percentage
of subjects with a local reaction within 7 days of second vaccinationb 0.2 0.2
Maximum difference (updated data -CSR data) across any systemic event term of the
percentage of subjects with a systemic event within 7 days of first vaccinationb 0.1 0.0
Maximum difference (updated data -CSR data) across any systemic event term of the
percentage of subjects with a systemic event within 7 days of second vaccinationb 0.3 0.0
Maximum difference (updated data -CSR data) across any local reaction term of the du ration in
mean days following first vaccinationb 0.01 0.03
Maximum difference (updated data -CSR data) across any local reaction term of the duration in
mean days following second vaccinationb 0.0 0.17
Maximum difference (updated data -CSR data) across a ny systemic event term of the duration
in mean days following first vaccinationb 0.01 0.01
Maximum difference (updated data -CSR data) across any systemic event term of the duration
in mean days following second vaccinationb 0.02 0.02
Difference (updated data -CSR data) of number of subjects with a duration of a ny local reaction
>7 days following either vaccination 1 1
Difference (updated data -CSR data) of number of subjects with a duration of a ny systemic
event >7 days following either vaccination 2 1
Abbreviations: CRF = case report form; CSR = clinical study report
Note: CSR data is data reported in the CSR that was entered into the electronic diary by the subject and symptom resolved page by the investigator. Updated data
is the CSR data and the reactogenicity data entered in the AE log CRF page by the investigator.
a. An affected record is any record that changed during the reactogenicity update.
b. Maximum difference is displayed as a percentage and is for reactogenicity data.
090177e196f19a0a\Final\Final On: 04-May-2021 06:41 (GMT)
FDA-CBER-2021-5683-0023997