Document text
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
1 µg
Younger 10015 Pho
ne call was not performed Acc
. to CTP 3.0 section 'trial
de
sign' not necessary Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 01
MAY2020
Th
e measurement was not
pe
rformed in the scheduled time
Fram
e lo
gistic reason Vis
it Schedule Com p
liance Vis
it 1, 12 -le
ad ECG 29
APR2020
Th
e measurement was not
pe
rformed in the scheduled time
fram
e lo
gistic reason Vis
it Schedule Compliance Vis
it 1, Body Temperature,
pre
dose 29
APR2020
Th
e measurement was not
pe
rformed in the scheduled time
fram
e lo
gistic reason Vis
it Schedule Compliance Vis
it 1, Vital Signs, predose 29
APR2020
Urin
e pregnancy testing
pe
rformed Done
by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 1, Urine Pregnancy Test 29
APR2020
10018 FSH w a
s not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 23
APR2020
Me
asurements (Vital Signs,
ECG ) n
ot prior to Allocation do
ne by mistake Vis
it Schedule Compliance Vis
it 1, predose 29
APR2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 1 of 22
)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 1
FDA-CBER-2021-5683-0049419
Bi
oNTech RNA Pharmaceuticals Gm
bH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
1 µg
Younger 10018 Pho
ne call was not performed Acc
. to CTP 3.0 section 'trial
de
sign' not necessary Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 01
MAY2020
Th
e measurement was not
pe
rformed in the scheduled time
fram
e. lo
gistic reason Vis
it Schedule Com p
liance Vis
it 1, Body Temperature,
pre
dose 29
APR2020
10023 Pho
ne call was not performed Acc
. to CTP 3.0 section 'trial
de
sign' not necessary Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 07
MAY2020
10025 Me
asurement not prior to
All
ocation do
ne by mistake Vis
it Schedule Compliance Vis
it 1, Physical Examination 05
MAY2020
Pho
ne call was not performed Acc
. to CTP 3.0 section 'trial
de
sign' not necessary Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 07
MAY2020
10033 Pho
ne call was no
t performed Acc
. to CTP 3.0 section 'trial
de
sign' not necessary Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 07
MAY2020
Th
e measurements were not
pe
rformed in the scheduled
tim
eframe. Due t
o logistical reason
me
asurements at timepoints 1h,
3h
and 6h after vaccination
we
re performed out of the given
tim
eframe (+/ - 15
min.) Vis
it Schedule Compliance Vis
it 4, Body Temperature, 1h,
3h
, 6h after vaccination 26
MAY2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 2 of 22
)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 2
FDA-CBER-2021-5683-0049420
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.
2.1-2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
1 µg
Younger 10033 Th
e measurements were not
pe
rformed in the scheduled
tim
eframe. Due t
o lo
gistical reason
me
asurements at timepoints 1h,
3h
and 6h after vaccination
we
re performed out of the given
tim
eframe (+/ - 15
min.) Vis
it Schedule Compliance Vis
it 4, Vital Signs, 1h, 3h, 6h
aft
er vaccination 26
MAY2020
Th
e measurements were not
pe
rformed in the scheduled
tim
eframe. Due t
o logistical reason
me
asurements at timepoints 1h,
3h
and 6h after vaccination
we
re performed out of the given
tim
eframe (+/ - 15
min.) Vis
it Schedule Compliance Vis
it 4, Local Tolerability at
Inj
ection Site, 1h, 3 h,
6h after
va
ccination 26
MAY2020
10036 Diary
entries for Day 04.06.2020
for L
ocal and Systemic
Reac
tions are not available. Mi
ssing entries. Oth
er Vis
it 5 04
JUN2020
10040 Diary
entries for Day 04.06.2020
for L
ocal and Systemic
Reac
tions are not av
ailable. Mi
ssing entries. Oth
er Vis
it 5 04
JUN2020
10041 Diary
Entries for Day
04
.06.2020 for Local and
Sys
temic Reactions are not
av
ailable Mi
ssing Entries Oth
er Vis
it 5 04
JUN2020
FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data
,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 28
APR2020
10042 Diary
entries for Day 04.06.2020
for L
ocal and Systemic
Reac
tions are not available. Mi
ssing entries. Oth
er Vis
it 5 04
JUN2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 3 of 22
)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 3
FDA-CBER-2021-5683-0049421
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. Sn
apshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
1 µg
Younger 10045 Diary
entries for Day 02.06.2020
for Lo
cal and Systemic
Reac
tions are not available. Mi
ssing entries Oth
er Vis
it 5 02
JUN2020
FSH L e
vel was not determined. Done
by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 28
APR2020
Pho
ne call was not pe
rformed Acc
. to CTP 3.0 section 'trial
de
sign' not necessary Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 07
MAY2020
Th
e measurements were not
pe
rformed in the scheduled
tim
eframe Due t
o logistical reason
me
asurements at timepoints 1h,
3h an
d 6h after vaccination
we
re performed out of the given
tim
eframe (+/ - 15
min.) Vis
it Schedule Compliance Vis
it 4, Body Temperature, 1h,
3h
, 6h after vaccination 26
MAY2020
Th
e measurements were not
pe
rformed in the scheduled
tim
eframe Due t
o logistical rea
son
me
asurements at timepoints 1h,
3h
and 6h after vaccination
we
re performed out of the given
tim
eframe (+/ - 15
min.) Vis
it Schedule Compliance Vis
it 4, Vital Signs, 1h, 3h, 6h
aft
er vaccination 26
MAY2020
Th
e measurements were not
pe
rformed in the sc
heduled
tim
eframe Due t
o logistical reason
me
asurements at timepoints 1h,
3h
and 6h after vaccination
we
re performed out of the given
tim
eframe (+/ - 15
min.) Vis
it Schedule Compliance Vis
it 4, Local Tolerability at
Inj
ection Site, 1h, 3h, 6h after
va
ccinati
on 26
MAY2020
10048 Diary
entries for Day 04.06.2020
for L
ocal and Systemic
Reac
tions are not available. Mi
ssing entries. Oth
er Vis
it 5 04
JUN2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 4 of 22
)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 4
FDA-CBER-2021-5683-0049422
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data
received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protoco l
deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
1 µg
Younger 10048 Vis
it 7 not performed Due t
o private reason of the
su
bject Visit 7 was not
pe
rformed Vis
it Sc
hedule Compliance Vis
it 7 (a1, b1, b2, c2P/B)
(EoT
) 25
JUN2020
10052 Diary
entries for Day 03.06.2020
for L
ocal and Systemic
Reac
tions are not available. Mi
ssing entries. Oth
er Vis
it 5 03
JUN2020
Diary
entries for Day 04.06.2020
for L
ocal and Systemic
Reac
tions are not available. Mi
ssing entries. Oth
er Vis
it 5 04
JUN2020
3 µg
Younger 10170 Vita
l Signs and Body
Te
mperature measurements
pe
rformed, but values not
do
cumented va
lues not entered by mistake Oth
er Vis
it 3 07
AUG2020
10194 FSH L e
vel was de
termined do
ne by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 13
JUL2020
Pho
ne call was not performed no
t performed by mistake Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 24
JUL2020
di
ary entries for
local reactions
are
entered for only 5
co
nsecutive days after V4 (day
23-27) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 28, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Lo
cal Reactions 18
AUG2
020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 5 of 22
)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 5
FDA-CBER-2021-5683-0049423
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Fi
nal 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
3 µg
Yo
unger 10194 di
ary entries for local reactions
are
entered for only 5
co
nsecutive days after V4 (day
23-27) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 28, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, D ia
ry - Sys
temic
Reac
tions 18
AUG2020
10198 FSH L e
vel was determined do
ne by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 15
JUL2020
Pho
ne call was not performed no
t performed by mistake Vis
it Schedule Com p
liance Pho
ne Call at 48h, Phone Call 24
JUL2020
10200 Pho
ne call was not performed no
t performed by mistake Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 24
JUL2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 co
nsecutive days after
V4 (d
ay 23 -27) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 28, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Lo
cal Reactions 18
AUG2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
V4 (d
ay 23 -27) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 28, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Sys
temic
Reac
tions 18AUG2
020
10204 Pho
ne call was not performed no
t performed by mistake Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 24
JUL2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 6 of 22
)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 6
FDA-CBER-2021-5683-0049424
Bi
oNTech RNA Pha
rmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
3 µg
Younger 10204 di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
V4 (d
ay 23 -27) done by
mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 28, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Lo
cal Reactions 18
AUG2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 co
nsecutive days after
V4 (d
ay 23 -27) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 28, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Sys
temic
Reac
tions 18
AUG2020
10209 Pho
ne call was not pe
rformed no
t performed by mistake Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 24
JUL2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
V4 (d
ay 23 -27) do
ne by mistake, cause Visit 5
wa
s scheduled an
d performed
for d
ay 28, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Lo
cal Reactions 18
AUG2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
V4 (d
ay 23 -27) do
ne by mi
stake, cause Visit 5
wa
s scheduled and performed
for d
ay 28, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Sys
temic
Reac
tions 18
AUG2020
uri
ne pregnancy testing
pe
rformed do
ne by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Urine Pregnancy Test 17
JUL2020
10212 Pho
ne call was not performed no
t performed by mistake Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 24
JUL2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 7 of 22
)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 7
FDA-CBER-2021-5683-0049425
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
3 µg
Younger 10212 di
ary entries for local and
sy
stemic re
actions are entered
for o
nly 5 consecutive days after
V4 (d
ay 23 -27) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 28, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Lo
cal Reactions 18
AUG2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
V4 (d
ay 23 -27) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 28, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Di ary
- Sys
temic
Reac
tions 18
AUG2020
10221 Bod
y temperature time is not
co
rrect entered, time is
un
known Bod
y temperature measured
rig
ht after vitals signs, time
en
tered (12:30 h) by mistake.
Corre c
t time is unknown Vis
it Schedule Compliance Vis
it 4, Body Te
mperature, 3 h
a.v
. 21
AUG2020
10
µg Younger 10001 FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 22
APR2020
10003 FSH L e
vel was not determined. Done
by mistake. La
boratory Data
, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 22
APR2020
10005 FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 22
APR2020
10007 Vis
it 5 was postponed Due t
o urgent private reason
vi
sit was postponed in
ag
reement with investigator Vis
it Schedule Compliance Vis
it 5 25
MAY2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 8 of 22
)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 8
FDA-CBER-2021-5683-0049426
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
10
µg Younger 10008 FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 22
APR2020
Th
e measurement was not
pe
rformed in the scheduled time
fram
e. lo
gistic reason Vis
it Schedule Compliance Vis
it 1, Body Temperature,
pre
dose 28
APR2020
Th
e measurement was not
pe
rformed in the scheduled time
fram
e. lo
gistic reason Vis
it Sc
hedule Compliance Vis
it 1, Vital Signs, predose 28
APR2020
Th
e measurement was not
pe
rformed in the scheduled time
fram
e. lo
gistic reason Vis
it Schedule Compliance Vis
it 1, 12 -le
ad ECG 28
APR2020
10017 FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 23
APR2020
Me
asurements (Vital Signs,
ECG ) n
ot prior to Allocation do
ne by mistake Vis
it Schedule Compliance Vis
it 1, predose 28
APR2020
Th
e measurement was not
pe
rformed in
the scheduled time
fram
e. lo
gistic reason Vis
it Schedule Compliance Vis
it 1, Body Temperature,
pre
dose 28
APR2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 9 of 22
)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 9
FDA-CBER-2021-5683-0049427
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty se
t
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
10
µg Younger 10019 Me
asurements (Vital Signs,
ECG ) n
ot prior to Allocation do
ne by mistake Vis
it Schedule Compliance Vis
it 1, predose 28
APR2020
Th
e me
asurement was not
pe
rformed in the scheduled time
fram
e. lo
gistic reason Vis
it Schedule Compliance Vis
it 1, Body Temperature,
pre
dose 28
APR2020
20
µg Younger 10151 Me
asurements (Body
tem
p./Vital signs/ECG) not prior
to Al
location do
ne by mistake Vis
it Sc
hedule Compliance Vis
it 1, predose 16
JUL2020
Pho
ne call was not performed no
t performed by mistake Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 18
JUL2020
Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Th
erefore MEMO
03
Missing time ICF Version 6.0
wa
s written. By m
istake time was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
2020 for this Subject. Oth
er Unsc
heduled Forms, Informed
Cons
ent 16
JUL2020
10171 Me
asurements (Body
tem
p./Vital signs/ECG) not pri
or
to Al
location do
ne by mistake Vis
it Schedule Compliance Vis
it 1, predose 16
JUL2020
Pho
ne call was not performed no
t performed by mistake Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 18
JUL2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 10 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 10
FDA-CBER-2021-5683-0049428
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
20
µg Yo
unger 10171 Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Therefore MEMO
03
Missing time ICF Version 6.0
wa
s written. By m
istake time was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
2020 for this Subject. Oth
er Unsc
heduled Form
s, Informed
Cons
ent 16
JUL2020
10172 Me
asurements (Body
tem
p./Vital signs/ECG) not prior
to Al
location do
ne by mistake Vis
it Schedule Compliance Vis
it 1, predose 16
JUL2020
Pho
ne call was not performed no
t performed by mistake Vis
it Schedule Com p
liance Pho
ne Call at 48h, Phone Call 18
JUL2020
Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Therefore MEMO
03
Missing time ICF Version 6.0
wa
s written. By m
istake time was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
20
20 for this Subject. Oth
er Unsc
heduled Forms, Informed
Cons
ent 16
JUL2020
10173 Me
asurements (Body
tem
p./Vital signs/ECG) not prior
to Al
location do
ne by mistake Vis
it Schedule Compliance Vis
it 1, predose 16
JUL2020
Pho
ne call was not performed no
t pe
rformed by mistake Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 18
JUL2020
Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Therefore MEMO
03
Missing time ICF Version 6.0
wa
s written. By m
istake time was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
2020 for this Subject. Oth
er Unsc
heduled Forms, Informed
Cons
ent 16
JUL2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 11 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 11
FDA-CBER-2021-5683-0049429
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NO
V2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty se
t
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
20
µg Younger 10175 Me
asurements (Body
tem
p./Vital signs/ECG) not prior
to Al
location do
ne by mistake Vis
it Schedule Compliance Vis
it 1, predose 16
JUL2020
Pho
ne call was not performed no
t performed by mistake Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 18
JUL2020
Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Therefore MEMO
03
Missing time ICF Version 6.
0
wa
s written. By m
istake time was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
2020 for this Subject. Oth
er Unsc
heduled Forms, Informed
Cons
ent 16
JUL2020
10176 Me
asurements (Body
tem
p./Vital signs/ECG) not prior
to Al
location do
ne by mistake Vis
it Sc
hedule Compliance Vis
it 1, predose 16
JUL2020
Pho
ne call was not performed no
t performed by mistake Vis
it Schedule Compliance Pho
ne Call at 48h, Phone Call 18
JUL2020
Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Th
erefore MEMO
03
Missing time ICF Version 6.0
wa
s written. By m
istake time was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
2020 for this Subject. Oth
er Unsc
heduled Forms, Informed
Cons
ent 16
JUL2020
10178 Me
asurements (Body
tem
p./Vital signs/ECG) not pri
or
to Al
location do
ne by mistake Vis
it Schedule Compliance Vis
it 1, predose 16
JUL2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 12 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 12
FDA-CBER-2021-5683-0049430
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. Sn
apshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
20
µg Younger 10178 Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Therefore MEMO
03
Missing time ICF Version 6.0
wa
s written. By m
istake tim
e was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
2020 for this Subject. Oth
er Unsc
heduled Forms, Informed
Cons
ent 16
JUL2020
10179 Me
asurements (Body
tem
p./Vital signs/ECG) not prior
to Al
location do
ne by mistake Vis
it Schedule Compliance Vis
it 1, pr
edose 16
JUL2020
Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Therefore MEMO
03
Missing time ICF Version 6.0
wa
s written. By m
istake time was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
2020 for this Subject. Oth
er Unsc
heduled Forms, Informed
Cons
ent 16
JUL2020
10181 Diary
pages not returned and
rev
iewed Sub
ject left the site earlier than
pl
anned Vis
it Schedule Compliance Vis
it 5, Diary - Lo
cal Reactions 13
AUG2020
Me
asurements (Body
tem
p./Vital signs/ECG) not pri
or
to Al
location do
ne by mistake Vis
it Schedule Compliance Vis
it 1, predose 16
JUL2020
Phy
sical examination,
as
sessment of local and
sy
stemic reactions not done Sub
ject left the site earlier than
pl
anned Vis
it Schedule Compliance Vis
it 5 13
AUG2020
Th
e visit was performed outside
stu
dy scheme du
e to private reasons Vis
it Schedule Compliance Vis
it 8 (c2) (FU) / Visit 9 (a1,
b1
, b2) (FU) 14
OCT2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 13 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 13
FDA-CBER-2021-5683-0049431
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs
Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protoco l
deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
20
µg Younger 10181 Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Therefore MEMO
03
Missing time ICF Version 6.0
wa
s written. By m
istake time was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
2020 for this Subject. Oth
er Unsc
heduled Forms, Informed
Cons
ent 16
JUL2020
10182 Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Therefore MEMO
03
Missing time ICF Version 6.0
wa
s written. By m
istake time was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
2020 for this Subject. Oth
er Unsc
heduled Forms, Informed
Cons
ent 16
JUL2020
10183 Ti
me field for ICF Version 6.0,
da
ted on 26 JUN 2020 left blank
by
mistake. Therefore MEMO
03
Missing time ICF Version 6.0
wa
s written. By m
istake time was missing on
ICF Ve
rsion 6.0, dated on 26
JUN
2020 for this Subject. Oth
er Unsc
heduled Forms, Informed
Cons
ent 16
JUL2020
uri
ne pre
gnancy testing
pe
rformed do
ne by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Urine Pregnancy Test 09
JUL2020
uri
ne pregnancy testing
pe
rformed Preg
nancy test performed by
mi
stake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 4, Urine Preg
nancy Test 06
AUG2020
30
µg Younger 10016 Ass
essment of local reaction at
in
jection site was performed 4
mi
n later than the allowed time
wi
ndow lo
gistic reason Vis
it Schedule Compliance Vis
it 1, Local Tolerability at
Inj
ection Site, 06 h a.v. 29
APR2020
FSH L e
vel was not determined. do
ne by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 23
APR2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 14 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 14
FDA-CBER-2021-5683-0049432
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol dev
iations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
30
µg Younger 10016 Me
asurements (Body
Te
mperature, Vital Signs, ECG)
no
t prior to Allocation do
ne by mistake Vis
it Sc
hedule Compliance Vis
it 1, predose 29
APR2020
10020 FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 24
APR2020
Me
asurements (Vital Signs,
ECG ) n
ot prior to Allocation done by
mistake Vis
it Schedule Compliance Vis
it 1, predose 29
APR2020
Th
e measurement was not
pe
rformed in the scheduled
tim
eframe. lo
gistic reason Vis
it Schedule Compliance Vis
it 1, Body Temperature,
pre
dose 29
APR2020
10031 Th
e measurements were not
pe
rformed in the scheduled
tim
eframe Vis
it 2 Day 2 will be postponed
to d
ay 3, Subject is unable to
co
me into Unit due to Adverse
Eve
nt Vis
it Schedule Compliance Vis
it 2 08
MAY2020
10043 Diary
entries for Day 03.06.2020
for L
ocal and Systemic
Reac
tions are
not available. Mi
ssing entries Oth
er Vis
it 5 03
JUN2020
FSH L e
vel was not determined. Done
by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 28
APR2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 15 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 15
FDA-CBER-2021-5683-0049433
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on cl
ean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
30
µg Younger 10043 Th
e measurements were not
pe
rformed in th
e scheduled
tim
eframe Lo
gistical reason Vis
it Schedule Compliance Vis
it 4, Vital Signs, 1h, 3h and
6h
after 28
MAY2020
Th
e measurements were not
pe
rformed in the scheduled
tim
eframe Lo
gistical reason Vis
it Schedule Compliance Vis
it 4, Body Temperature, 1h
,
3h
and 6h after 28
MAY2020
Th
e measurements were not
pe
rformed in the scheduled
tim
eframe Lo
gistical reason Vis
it Schedule Compliance Vis
it 4, Local Tolerability at
Inj
ection Site, 1h, 3h and 6h
aft
er 28
MAY2020
Urin
e Pregnancy Test
Perfo
rmed Done by
Mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 4, Urine Pregnancy Test 28
MAY2020
50
µg Younger 10050 FSH L e
vel was not determined. Done
by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 05
MAY2020
10055 Diary
entries for Day 09.06.2020
for L
ocal and Systemic
Reac
tions are not available. Mi
ssing Entries Oth
er Vis
it 5 09
JUN2020
FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 07
MAY2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 16 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 16
FDA-CBER-2021-5683-0049434
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
50
µg Younger 10055 Urin
e Pregnancy Testing
Perfo
rmed Done
by Mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Urine Pregnancy Test 07
MAY2020
10056 Ass
essment of local reaction at
in
jection site was performed 7
mi
n later than the al
lowed time
wi
ndow du
e to logistic reason
as
sessment was performed
la
ter Vis
it Schedule Compliance Vis
it 1, Local Tolerability at
Inj
ection Site, 6 h.a.v. 13
MAY2020
Diary
entries for Day 09.06.2020
for L
ocal and Systemic
Reac
tions are not available. Mi
ssing entries. Oth
er Vis
it 5 09
JUN2020
FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 07
MAY2020
Th
e planned activities were not
pe
rformed in the scheduled
tim
eframe due to l
ogistic reason phone call
wa
s performed earlier. Vis
it Schedule Compliance Pho
ne Call at 48h 15
MAY2020
10059 Diary
entries for Day 09.06.2020
for L
ocal and Systemic
Reac
tions are not available. Mi
ssing entries Oth
er Vis
it 5 09
JUN2020
FSH L e
vel wa
s not determined Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 07
MAY2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 17 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 17
FDA-CBER-2021-5683-0049435
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
50
µg Younger 10059 Th
e planned activities were not
pe
rformed in the scheduled
tim
eframe Due t
o logistic reason phone
ca
ll was performed ea
rlier Vis
it Schedule Compliance Pho
ne Call at 48h 15
MAY2020
10060 Diary
entries for Day 09.06.2020
for L
ocal and Systemic
Reac
tions are not available. Mi
ssing entries. Oth
er Vis
it 5 09
JUN2020
Sub
ject takes Novaminsulfon
(ora
l, 1x1tbl. 500 mg) Sub
ject had lost his "take -ho
me
gi
ven Paracetamol tablets", \n
so
instead he took
Nova
minsulfon Tre
atment Compliance Unre l
ated Forms,
Prio
r/Concomitant
Me
dication/Therapy 14
MAY2020
Th
e planned activities were not
pe
rformed in the scheduled
tim
eframe du
e to logistic reason phone call
wa
s performed earlier. Vis
it Schedule Compliance Pho
ne Call at 48h 15
MAY2020
10068 FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 08
MAY2020
10073 FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 11
MAY2020
60
µg Younger 10075 FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 11
MAY2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 18 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 18
FDA-CBER-2021-5683-0049436
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
60
µg Younger 10076 FSL l
evel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 11
MAY2020
10083 FSH l e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 12
MAY2020
10089 FSH L e
vel was not determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 12
MAY2020
10103 FSH L e
vel was no
t determined. Done
by mistake. La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 14
MAY2020
10104 Th
e planned activities were not
pe
rformed in the scheduled
tim
eframe Te
lephone call earlier due to
lo
gistic reason Vis
it Sc
hedule Compliance Pho
ne Call at 48h 22
MAY2020
10
µg Older 10274 Chec
k was performed too early do
ne by mistake Vis
it Schedule Compliance Vis
it 1, Local Tolerability at
Inj
ection Site, 3 h a.v. 27
AUG2020
Chec
k was performed too early do
ne by mistake Vis
it Schedule Compliance Vis
it 1, Systemic Events
Ass
essment, 3 h a.v. 27
AUG2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 19 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 19
FDA-CBER-2021-5683-0049437
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
10
µg Older 10274 wro
ng entry for pulse rate (012),
so
value is unknown wro
ng entry by mistake Oth
er Vis
it 6 (a1, b1, b2, c2P/B) /
(c2
) (EoT), Vital Signs 08
OCT2020
10282 no de
tailed information beside
da
te/day reported in diary on
da
y 3-7 su
bject forgot to enter data Tre
atment Compliance Unre l
ated Forms, Diary - Lo
cal
Reac
tions, Day 3 -7 22
AUG2020
uri
ne sample was given outside
the
scheduled time frame of +/ -2
h o
f va
ccination su
bject couldn't wait any longer
to g
ive urine. Vis
it Schedule Compliance Vis
it 2, Urine Sampling for
Urin
alysis 21
AUG2020
10292 ite
ms for nausea and vomiting
no
t assessed do
ne by mistake Tre
atment Compliance Vis
it 5, Systemic Events
Ass
essment 24
SEP2020
wro
ng entry for pulse rate (011),
so
value is unknown wro
ng entry by mistake Oth
er Vis
it 6 (a1, b1, b2, c2P/B) /
(c2
) (EoT), Vital Signs 08
OCT2020
10298 me
asurements performed, but
va
lues not documented va
lues not entered by mi
stake Oth
er Vis
it 6 (a1, b1, b2, c2P/B) /
(c2
) (EoT), Vital Signs 08
OCT2020
20
µg Older 20234 Th
e PCR test was repeated at
Vis
it1 before the predose
rec
ording, because at Visit -1
the
test was not evaluable the
first test was failed La
boratory Data, ECG Data
,
Preg
nancy Data Vis
it 1, Oral Swipe for SARS -
CoV-2 T
esting 09
SEP2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 20 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 20
FDA-CBER-2021-5683-0049438
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDT
M data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
20
µg Older 20239 da
y 28 - da
ta missing ha
s not been filled in by subject Oth
er Vis
it 5, Diary - Lo
cal
Reac
tions, day 28 08
OCT2020
30
µg Older 10351 By m
istake, allocation was done
be
fore the alcohol breath testing do
ne by mistake Vis
it Schedule Compliance Vis
it 1, Allocation 25
SEP2020
di
ary entries for local reactions
are
entered for only 5
co
nsecutive days after V4 (until
da
y 27) do
ne by mistake Tre
atment Compliance Unre l
ated For
ms, Diary - Lo
cal
Reac
tions 21
OCT2020
di
ary entries for systemic
rea
ctions are entered for only 5
co
nsecutive days after V4 (until
da
y 27) do
ne by mistake Tre
atment Compliance Unre l
ated Forms, Diary -
Sys
temic Reactions 21
OCT2020
10358 All
ocation wa
s done prior to
pre
dose measurements (vital
si
gns, body temperature, ecg) do
ne by mistake Vis
it Schedule Compliance Vis
it 1, Allocation 23
SEP2020
Me
asurements (Body
tem
p./Vital signs/ECG) not prior
to a
llocation do
ne by mistake Vis
it Schedule Com p
liance Vis
it 1, Vital Signs, Predose 23
SEP2020
10360 pre
defined timeframe of 30
mi
nutes between the
va
ccination of subjects was not
ad
hered. (done after 29
mi
nutes) do
ne by mistake 1 min. too early Tre
atment Compliance Vis
it 1, Administration 23
SEP2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 21 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 21
FDA-CBER-2021-5683-0049439
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-1:
Listing of protocol deviations - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
30 µg O
lder 10362 No m
odules except for fever
we
re ticked, although
as
sessments were done. No
sy
mptoms were reported. do
ne by mistakte Oth
er Vis
it 4, Systemic Events
Ass
essment, 3 h a.v. 16
OCT2020
10364 di
ary entries for systemic
rea
ctions are entered for on
ly 5
co
nsecutive days after V4 (until
da
y 27) do
ne by mistake Tre
atment Compliance Unre l
ated Forms, Diary -
Sys
temic Reactions 21
OCT2020
uri
ne sample was given outside
the
scheduled time frame of +/ -2
h o
f vaccination su
bject couldn't wait any longer
to g
ive urine. Vis
it Schedule Compliance Vis
it 2, Urine Sampling for
Urin
alysis 26
SEP2020
10366 uri
ne sample was given outside
the
scheduled time frame of +/ -2
h o
f vaccination su
bject couldn't wait any longer
to g
ive urine. Vis
it Schedule Compliance Vis
it 2, Urine Sampling for
Urin
alysis 24
SEP2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 22 of 22)
090177e1959f772b\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 22
FDA-CBER-2021-5683-0049440
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-3:
Li
sting of protocol deviations - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
1 µg
Younger 20158 No e
ntries available. The test
Pers
on appears on day 26. The
Diary
was collected lo
gistic reason Vis
it Schedule Compliance Vis
it 5, Diary - Lo
cal
Reac
tions, Day 29 07
AUG2020
No e
ntries available. The test
Pers
on appears on day 26. The
Diary
was collected lo
gistic reason Vis
it Schedule Compliance Vis
it 5, Diary - Sys
temic
Reac
tions, Day 2
9 07
AUG2020
the
action took place 20 minutes
la
ter, 5 minutes outside the time
ran
ge lo
gistic reason Vis
it Schedule Compliance Vis
it 1, Systemic Events
Ass
essment, 1h 13
JUL2020
the
action took place 20 minutes
la
ter, 5 minutes outside the time
ran
ge lo
gistic reason Vis
it Schedule Compliance Vis
it 1, Local Tolerability at
Inj
ection Site, 1h 13
JUL2020
20164 an
additional Control test on
vi
sit 4 drior to vaccination Th
e test person returned from a
co
rona endangered area 4 days
ago Oth
er Vis
it 4, Ora
l Swipe for SARS -
CoV-2 T
esting 03
AUG2020
3 µg
Younger 20197 Bod
y temperature measurement
is
2 minutes out of range of
tol
erance ( 2 minutes too early) sta
ff error Vis
it Schedule Compliance Vis
it 2, Body Temperature, 24
h 29
JUL2020
20204 All
measures are
outside the 2h
tim
edeviation Th
e subject had time problems Vis
it Schedule Compliance Vis
it 2 01
AUG2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 1 of 8)
090177e1959f772c\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 23
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-3:
Listing of protocol deviations - BN
T162b2
Safe
ty set
Dose
gr
oup Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
10
µg Younger 20105 Ass
essment not done because
the
CRF was not available at
tha
t time no
actual CRF file available Vis
it Schedule Compliance Vis
it 5, Systemic Eve
nts
Ass
essment, D29 14
JUL2020
20110 FSH i s
missing, subject has a
tub
al ligation no
t specified La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Blood Samples for
Safe
ty Lab 19
MAY2020
ce
ntrifugation Glucose 8
mi
nutes too late sta
ff error La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 3, Blood Samples for
Safe
ty Lab 22
JUN2020
20111 Th
e test person had rhinitis on
da
y 22 and could not be
va
ccinated. The vaccination was
de
layed on day 28. rhi
nititis Me
dical History and
Conc
omitant Diseases Vis
it 4, Administration 15
JUL2020
Th
e visit 5 day 29 was moved to
da
y 36. di
splaced booster Tre
atment Compliance Vis
it 5 23
JUL2020
20116 Sub
ject cancelled booster du
e to feeling cold Tre
atment Compliance Vis
it 4, D22 09
JUL2020
Vis
it 6 was skipped be
cause
su
bject \n p
rematurely
term
inated the Trial, so EoT \n
Vis
it 7 was performed earlier
tha
n \n
planned. the
subject ends the study by
thi
s day Vis
it Schedule Compliance Vis
it 6 (a1, b1, b2, c2P/B) /
(c2
) (EoT), D43 30
JUL2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 2 of 8)
090177e1959f772c\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 24
FDA-CBER-2021-5683-0049442
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDT
M data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-3:
Listing of protocol deviations - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
20
µg Yo
unger 20159 Th
e subject moved his visit 6 by
5 d
ays. That's one day too many tim
e problem by volunteer Vis
it Schedule Compliance Vis
it 6 (a1, b1, b2) / (c2) (EoT) 07
AUG2020
20175 Pho
ne Call not performed sta
ff error Vis
it Schedule Compliance Pho
ne Call at
48h, Phone Call 09
JUL2020
20180 Th
e consent form for
"Ph
armagenomic Examination
HLA" w
as signed 3 min before
the
consent form version 6.0
Proto
col Version 7.0, June 26,
2020 sta
ff error Oth
er Vis
it 1, Informed Consent +
Blo
od Sampling for HLA typing 13
JUL2020
20183 Bod
y temperature was
me
asured outside the allowed
tim
eframe ( 13 min too early) sta
ff error La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 2, Body Temperature, 24
h (+
/- 2h
) 14
JUL2020
Th
e consent form for
"Ph
armagenomic Examination
HLA" w
as signed 2 min before
the
consent form version 6.0,
Ju
ne 26, 2020 sta
ff error Oth
er Vis
it 1, Informed Consent +
Blo
od Sampling for HLA typing 13
JUL2020
30
µg Younger 20149 ce
ntrifugation 13 minutes too
ea
rly Staff
error La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 1, Blood Samples for
Imm
unogenicity 22
JUN2020
20150 Bec
ause of private
ap
pointments of the subject, this
ap
pointment is cancelled
co
mpletely. tim
e problem by volunteer Vis
it Schedule Compliance Vis
it 6 (a1, b1, b2) / (c2)
(EoT
), all 04
AUG2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 3 of 8)
090177e1959f772c\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 25
FDA-CBER-2021-5683-0049443
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on cl
ean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-3:
Listing of protocol deviations - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
30 µg Y
ounger 20155 Sub
ject removed from the room
un
asked before the
me
asurements, so the
me
asures were taken a few
mi
nutes too late mi
stake by subject Tre
atment Compliance Vis
it 4, Vital Signs, D22 (1h
aft
er Vaccination) 14
JUL2020
10
µg Older 10261 Dose
wa
s given in two parts Due t
o mix -up
with previous
CTP t
he wrong dose was
pre
pared (3µg). Shortly after
ad
ministration the mistake was
rec
ogniced and the remaining 7
µg h
ave been administered after
cl
arification with the sp Tre
atment Compliance Vis
it 1, Ad mi
nistration 14
AUG2020
Pho
ne call was not performed in
the
scheduled time frame ca
ll was too late due to
vo
lunteers problems with its
mo
bile phone Vis
it Schedule Compliance Pho
ne Call at 48h (a1, b1, b2,
c2
P/B), Phone Call 07
SEP2020
10263 pre
defined tim
eframe of 30
mi
nutes between the
va
ccination of subjects was not
ad
hered. Prev
ious subject (0261) was
do
sed in two parts, only 1st
va
ccination time of this subject
wa
s regarded. Tre
atment Compliance Vis
it 1, Administration 14
AUG2020
uri
ne sample was gi
ven outside
the
scheduled time frame of +/ -2
h o
f vaccination su
bject couldn't wait any longer
to g
ive urine. Vis
it Schedule Compliance Vis
it 2, Urine Sampling for
Urin
alysis 15
AUG2020
10265 Chec
k was performed too late du
e to emergency call of the
ch
ecking physician Vis
it Schedule Compliance Vis
it 4, Local Tolerability at
Inj
ection Site, 1 h a.v. 08
SEP2020
Chec
k was performed too late du
e to emergency call of the
ch
ecking physician Vis
it Schedule Compliance Vis
it 4, Systemic Events
Ass
essment, 1 h a
.v. 08
SEP2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 4 of 8)
090177e1959f772c\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 26
FDA-CBER-2021-5683-0049444
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-3:
Listing of protocol deviations - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
10
µg Older 10265 Vita
l signs and body
tem
perature were performed
ou
tside the allowed time window
of
+/-15
min do
ne by mistake Vis
it Schedule Compliance Vis
it 4, Vital Signs, 1 h a.v. 08
SEP2020
10267 Bod
y temperature was
pe
rformed outside the al
lowed
tim
e window of +/ -15
min do
ne by mistake Vis
it Schedule Compliance Vis
it 4, Body Temperature, 3 h
a.v
. 08
SEP2020
Bod
y temperature was
pe
rformed outside the allowed
tim
e window of +/ -15
min do
ne by mistake Vis
it Schedule Compliance Vis
it 4, Body Te
mperature, 6 h
a.v
. 08
SEP2020
10268 Urin
e pregnancy test performed do
ne by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Urine Pregnancy Test 05
AUG2020
Vita
l signs and body
tem
perature were performed
ou
tside the allowed time window
of +/-15
min do
ne by mistake Vis
it Schedule Compliance Vis
it 4, Vital Signs, 1 h a.v. 08
SEP2020
10276 me
asurements performed, but
va
lues not documented va
lues not entered by mistake Oth
er Vis
it 2, Physical Examination 21
AUG2020
10299 Vita
l Signs and body
tem
perature: measurements
pe
rformed, but values not
do
cumented va
lues not entered by mistake Oth
er Vis
it 3 27
AUG2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 5 of 8)
090177e1959f772c\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 27
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-3:
Listing of protocol deviations - BN
T162b2
Safe
ty se
t
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
20
µg Older 20225 Th
e blood can't quite be
di
stributed Not e
nough material La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 3, Blood Samples for
Imm
unogenicity 02
SEP2020
30
µg Older 10272 di
ary entries for local reactions
are
entered for only 4
co
nsecutive days after V4 (day
22-25) do
ne by mistake Tre
atment Compliance Vis
it 5, Diary - Lo
cal Reactions 29
SEP2020
di
ary entries for systemic
rea
ctions are entered for only 5
co
nsecutive days after V4 (day
22-26) do
ne by mistake Tre
atment Compliance Vis
it 5, Diary - Sys
temic
Reac
tions 29
SEP2020
10303 Urin
e pregnancy testing
pe
rformed do
ne by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 1, Urine Pregnancy Test 04
SEP2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
V4 (d
ay 22 -26) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 27, so no entries were at
si
te by su
bject itself Tre
atment Compliance Vis
it 5, Diary - Lo
cal Reactions 30
SEP2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
V4 (d
ay 22 -26) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 27
, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Sys
temic
Reac
tions 30
SEP2020
10305 No CM
I samples taken lo
gistic reasons La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 5, Blood Samples for CMI 02
OCT2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 6 of 8)
090177e1959f772c\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 28
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-3:
Listing of protocol deviations - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
30
µg Older 10306 Urin
e pregnancy testing
pe
rformed do
ne by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 0, Urine Pregnancy Test 21
AUG2020
10308 Me
asurement performed but
va
lue not documented Val
ue not entered by mistake Vis
it Schedule Compliance Vis
it 4, Bod
y Temperature, 6 h
a.v
. 24
SEP2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
V4 (d
ay 22 -26) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 27, so no entries were at
si
te by su
bject itself Tre
atment Compliance Vis
it 5, Diary - Lo
cal Reactions 30
SEP2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
V4 (d
ay 22 -26) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 27
, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Sys
temic
Reac
tions 30
SEP2020
10310 Bod
y temperature was
pe
rformed outside the allowed
tim
e window of +/ - 15
min do
ne by mistake Vis
it Schedule Compliance Vis
it 4, Bod
y Temperature, 1 h
a.v
. 23
SEP2020
10319 Urin
e pregnancy testing
pe
rformed do
ne by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 1, Urine Pregnancy Test 04
SEP2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 co
nsecutive days after
aft
er V4 (day 22 -26 do
ne by mistake Tre
atment Compliance Vis
it 5, Diary - Lo
cal Reactions 30
SEP2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 7 of 8)
090177e1959f772c\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 29
FDA-CBER-2021-5683-0049447
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -2-3:
Listing of protocol deviations - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Desc
ription Reas
on for deviation Code
d term Refe
rence Date
of
oc
curance
30
µg Older 10319 di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
aft
er V4 (day 22 -26 do
ne by mi
stake Tre
atment Compliance Vis
it 5, Diary - Sys
temic
Reac
tions 30
SEP2020
10323 Urin
e pregnancy test was
pe
rformed do
ne by mistake La
boratory Data, ECG Data,
Preg
nancy Data Vis
it 1, Urine Pregnancy Test 04
SEP2020
di
ary entries for local and
sy
stemic re
actions are entered
for o
nly 5 consecutive days after
V4 (d
ay 22 -26) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 27, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Diary - Lo
cal Reactions 30
SEP2020
di
ary entries for local and
sy
stemic reactions are entered
for o
nly 5 consecutive days after
V4 (d
ay 22 -26) do
ne by mistake, cause Visit 5
wa
s scheduled and performed
for d
ay 27, so no entries were at
si
te by subject itself Tre
atment Compliance Vis
it 5, Di ary
- Sys
temic
Reac
tions 30
SEP2020
Prog
ram: Lb
ase_PD_2.sas (Pag
e 8 of 8)
090177e1959f772c\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 30
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