Document text
Site:CRS Mannheim
Group:Part A
Subject Identifier: 276-01-0010
Status:Discontinued
1
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057374
Row oo sNo
do e Reaso o
do e Da e e Hea Ra e
(bea s/ )I e p e a o C ca
S g f ca ce F d gs,
select all that
apply
1 [ ]22/04/202
0
22 Ap 202009:35 59 [x] No a [ ] Ab o a [ ] NCS [ ] CS
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
2
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057375
[ ]
Row ToolsNot
done Reason not
done Date Time Result
1 [ ]22/04/2020
22-Apr-202009:18 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Alcohol Breath Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
3
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057376
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]22/04/2020
22-Apr-202009:22 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
4
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057377
Row ToolsNot
done
Reason not
done Date Time Height
(cm)Weight
(kg)Body Mass
Index
(kg/m²)BMI
(calculated)
(kg/m²)
1 [ ]22/04/2020
22-Apr-202008:57 166 65,1 23,6 23,6
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Body Height/Weight + BMI (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
5
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057378
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]22/04/2020
22-Apr-202009:37 Oral 36 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
6
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057379
Non-childbearing potential
Date of Last menses
Date of Sterilization
Other , please specifyChildbearing potential [x] No [ ] Yes [ ] NA
[ ] Postmenopausal (>=12 months)
[ ] Surgically sterilized
[x] Other
Hysterecto
my
NK/NK/2001
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Childbearing Potential (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
7
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057380
Age
Sex
Race,
select all that apply
If Other, please specify
Ethnicity53 years
1 months
[ ] Male
[x] Female
[x] White
[ ] Black or African American
[ ] Asian
[ ] American Indian or Alaska Native
[ ] Native Hawaiian or Other Pacific Islander
[ ] Not reported
[ ] Unknown
[ ] Other [x] Not Hispanic or Latino
[ ] Hispanic or Latino
[ ] Not reported
[ ] Unknown
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Demographic Data (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
8
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057381
DateSubject meets all inclusion
criteria and does not
meet any exclusion criteria? [ ] No [x] Yes
23/04/2020
23-Apr-2020
If No, please select all violated
In-/Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: In-/Exclusion Criteria (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
9
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057382
Date
Time
PID
Protocol Version
Was the subject re-screened?
All previous TSNs (e.g. 276-
01-1234)
Date of first Informed
Consent22/04/2020
22-Apr-2020 *
08:47
110990
3.0, 17 Apr
2020
[x] No [ ] Yes
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Informed Consent (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
10
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057383
Reason not done
Date
TimeNot done [ ]
22/04/2020
22-Apr-2020
10:49
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1General
condition/p
syche [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2Skin [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3Lymph
nodes [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4Head (eyes,
ears,
mouth) [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5Neck/thyroi
d gland [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6Lungs [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7Heart [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8Abdomen [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9Musculoskel
etal system [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10Neurologica
l system [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
11
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057384
11Vascular
system [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12Cardiovascu
lar [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13Gastrointes
tinal [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
14Other [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
12
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057385
[ ]
Row ToolsNot
done Reason not
done Date Time Methamphetamines Opiates Cocaine Cannabinoids Phencyclidine Benzodiazepines Barbiturates Methadone Tricyclic
antidepressants Amphetamines
1 [ ]22/04/2020
22-Apr-202009 16 [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Urine Drug Screen (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
13
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057386
[ ]
Row Tools NA Not
done Reason not
done Date Time Result
1 [x] [ ] [ ] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:23 (W. Europe Standard Time)
14
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057387
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]22/04/2020
22-Apr-202009:16
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
15
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057388
Row oo sNo
do e
Reaso o
do e Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1 [ ]22/04/202
0
22 Ap 202009:36 [x] R g [ ] Lef 131 [ ] NCS [ ] CS 88 [ ] NCS [ ] CS 57 [ ] NCS [ ] CS 12 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
16
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057389
Row oo sNo
do e Reaso o
do e Da e e Hea Ra e
(bea s/ )I e p e a o C ca
S g f ca ce F d gs,
select all that
apply
1 [ ]24/04/202
0
24 Ap 202008:34 60 [x] No a [ ] Ab o a [ ] NCS [ ] CS
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
17
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057390
Reason not done
Other, specify
Date
Time
Medication Number
Planned dose
Other, specify
If No, please specifyNot done
Total Dose (Volume of
Injection)
Total Dose given?
If No, rest volume
Application site
Administration according to
protocol?
Epi/Pandemic related
adjustment
Epi/Pandemic related
interruption [ ]
24/04/2020
24-Apr-2020
12:15
10025
10 ug
ug
0,5 mL
[ ] No [x] Yes
mL
[x] right [ ] left upper arm
[ ] No [x] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
18
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057391
[ ]
Row ToolsNot
done Reason not
done Date Time Result
1 [ ]24/04/2020
24-Apr-202008:13 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Alcohol Breath Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
19
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057392
Date
Time
Subject is allocated to
Group24/04/2020
24-Apr-2020
12:06
[x] Cohort 1
[ ] Cohort 2
[ ] Cohort 3
[ ] Cohort 4
[ ] Cohort 5
[ ] Cohort 6
[ ] Cohort 7
[ ] Cohort 8
[ ] Cohort 9
[ ] Cohort 10
[ ] A (BNT162a1)
[x] B (BNT162b1)
[ ] C (BNT162b2)
[ ] D (BNT162c2)
[ ] E (BNT162c2 P/B)
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Allocation (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
20
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057393
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]24/04/2020
24-Apr-202012:00
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Blood Samples for CMI (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
21
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057394
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]24/04/2020
24-Apr-202008:41
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
22
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057395
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]24/04/2020
24-Apr-202008:41 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
23
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057396
Row ToolsScheduled
time Not
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1Predose [ ] 24/04/2020
24-Apr-202008:36 Oral 36,2 [ ] NCS [ ] CS
21 hour [ ] 24/04/2020
24-Apr-202013:14 Oral 36,3 [ ] NCS [ ] CS
33 hours [ ] 24/04/2020
24-Apr-202015:14 Oral 36,3 [ ] NCS [ ] CS
46 hours [ ] 24/04/2020
24-Apr-202018:14 Oral 36,2 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
24
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057397
DateSubject meets all inclusion
criteria and does not
meet any exclusion criteria? [ ] No [x] Yes
24/04/2020
24-Apr-2020
If No, please select all violated
In-/Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: In-/Exclusion Criteria (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
25
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057398
[ ]
Row oo sSc edu ed
e No
do e
Reaso o
do e Da e e I e s y of a I e s y of e de ess I e s y of
E y e a/Red ess I e s y of
I du a o /Swe g
11 ou [ ]24/04/202
0
24 Ap 202013:15 [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g
23 ou s [ ]24/04/202
0
24 Ap 202015:17 [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g
36 ou s [ ]24/04/202
0
24 Ap 202018:15 [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
26
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057399
[ ]
Row ToolsNot
done
Reason not
done
Date Time Test name
Result
1 [ ]23/04/2020
23-Apr-202010:23 On site:
Bosch [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Oral Swipe for SARS-CoV-2 Testing (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
27
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057400
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
24/04/2020
24-Apr-2020
07:55
[ ] No [x] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
11 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
28
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057401
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
29
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057402
[ ]
Row ToolsNot
done Reason not
done Date Time Methamphetamines Opiates Cocaine Cannabinoids Phencyclidine Benzodiazepines Barbiturates Methadone Tricyclic
antidepressants Amphetamines
1 [ ]24/04/2020
24-Apr-202008 10 [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Urine Drug Screen (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
30
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057403
[ ]
Row Tools NA Not
done Reason not
done Date Time Result
1 [x] [ ] [ ] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
31
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057404
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]24/04/2020
24-Apr-202008:10
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
32
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057405
Row ToolsScheduled
time Not
done
Reason not
done Date Time Measurement side
(Arm) Systolic Blood
Pressure
(mmHg)Clinical
Significance
Diastolic Blood
Pressure
(mmHg)Clinical
Significance
Pulse Rate
(beats/min)Clinical
Significance
Respiratory
Rate
(breaths/min)Clinical
Significance
1Predose [ ]24/04/2020
24-Apr-202008 38 [x] Right [ ] Left124 [ ] NCS [ ] CS90 [ ] NCS [ ] CS56 [ ] NCS [ ] CS12 [ ] NCS [ ] CS
21 hour [ ]24/04/2020
24-Apr-202013 14 [x] Right [ ] Left115 [ ] NCS [ ] CS69 [ ] NCS [ ] CS61 [ ] NCS [ ] CS15 [ ] NCS [ ] CS
33 hours [ ]24/04/2020
24-Apr-202015 14 [x] Right [ ] Left129 [ ] NCS [ ] CS79 [ ] NCS [ ] CS58 [ ] NCS [ ] CS11 [ ] NCS [ ] CS
46 hours [ ]24/04/2020
24-Apr-202018 14 [x] Right [ ] Left105 [ ] NCS [ ] CS65 [ ] NCS [ ] CS68 [ ] NCS [ ] CS14 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
33
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057406
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]25/04/2020
25-Apr-202008:55 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
34
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057407
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]25/04/2020
25-Apr-202008:53 Oral 35,9 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
35
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057408
[ ]
Row Too sNot
done
Reason not
done Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]25/04/2020
25 Apr 20200:30 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
36
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057409
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
25/04/2020
25-Apr-2020
10:31
[ ] No [x] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
11 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
37
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057410
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
38
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057411
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]25/04/2020
25-Apr-202008:35
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
39
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057412
Row oo sNo
do e
Reaso o
do e Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1 [ ]25/04/202
0
25 Ap 202008:52 [x] R g [ ] Lef 126 [ ] NCS [ ] CS 77 [ ] NCS [ ] CS 64 [ ] NCS [ ] CS 14 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
40
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057413
Phone call only valid for the first 6 subjects per cohort. For the last 6 subjects please tick NA.
Row Tools NA Not
done Reason not
done Date Time Outcome of
the call (e.g.
No findings or
new AEs/CMs
reported)
1 [ ] [ ]26/04/2020
26-Apr-202012:30 Findings or
new
AEs/CMs
reported
Please document any additional information / changes in the appropriate forms!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Phone Call at 48h
Group: Part A
Form: Phone Call (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
41
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057414
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]30/04/2020
30-Apr-202009:15
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
42
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057415
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]30/04/2020
30-Apr-202009:15 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
43
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057416
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]30/04/2020
30-Apr-202009:13 Oral 36,3 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:24 (W. Europe Standard Time)
44
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057417
[ ]
Row Too sNot
done
Reason not
done Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]30/04/2020
30 Apr 20200:03 [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
45
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057418
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
30/04/2020
30-Apr-2020
10:04
[ ] No [x] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
11 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
46
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057419
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
47
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057420
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]30/04/2020
30-Apr-202008:30
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
48
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057421
Row oo sNo
do e
Reaso o
do e Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1 [ ]30/04/202
0
30 Ap 202009:12 [x] R g [ ] Lef 129 [ ] NCS [ ] CS 87 [ ] NCS [ ] CS 60 [ ] NCS [ ] CS 17 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
49
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057422
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]19/05/2020
19-May-202009:53 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
50
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057423
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]19/05/2020
19-May-202009:46 Oral 35,9 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
51
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057424
[ ]
Row Too sNot
done
Reason not
done Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]9/05/2020
9 May 20200:08 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
52
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057425
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
19/05/2020
19-May-2020
10:09
[ ] No [x] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
11 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
53
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057426
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
54
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057427
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]19/05/2020
19-May-202009:36
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
55
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057428
Row oo sNo
do e
Reaso o
do e Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1 [ ]19/05/202
0
19 May 202009:46 [x] R g [ ] Lef 123 [ ] NCS [ ] CS 81 [ ] NCS [ ] CS 62 [ ] NCS [ ] CS 13 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
56
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057429
Date of Completion or Early
Withdrawal
Main Reason for premature
termination
Date of Death
Other, specify:
Date of last visit/contactTrial fully completed?
Epi-/Pandemic related [x] No [ ] Yes
19/05/2020
19-May-2020
[x] Adverse Event
[ ] Death
[ ] Lost to Follow-up
[ ] Physician Decision
[ ] Pregnancy
[ ] Protocol Deviation
[ ] Screen Failure
[ ] Site Terminated by Sponsor
[ ] Study Terminated by Sponsor
[ ] Technical Problems
[ ] Withdrawal by Subject
[ ] Other [x] No [ ] Yes
22/05/2020
22-May-2020
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: End of Trial
Group: Part A
Form: End of Trial (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
57
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057430
Any Adverse Events?E reporting accord ng BN 62 reporting of E and reactions 03 uly2020
[ ] No [x] Yes *
Row ools E No dverse E ent
Serious Reason
select all that apply E of special
nterest Epi /Pandemic
related
Start Date Start me Start
me
unkn
End Date End ime End
me
unkn
Ongoing Se erity/Intens ty Intens ty (toxic ty grading
scale) reatment
emergent E
Relationship to
IMP reatment
DL (Dose lmiting
toxic ty)
ction taken with IMP
reatment Concomitant
medication or
therapy
Outcome of E E Group ID 3 F u like
symptoms [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes25/0 /2020
25 pr 20200: 0 [ ]07/05/2020
07 May 2020 [x] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [ ] No [x] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown5Loose stool [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes25/0 /2020
25 pr 20202 :00 [ ]26/0 /2020
26 pr 202020:00 [ ] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not recovered/not resolved
[ ] Recovered/resolved
[ ] Recovered/resolved with sequelae
[x] Recover ng/resolving
[ ] Fatal
[ ] Unknown65 Loose stool [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes26/0 /2020
26 pr 202020:00 [ ]27/0 /2020
27 pr 20202 :00 [ ] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown98 stress
dyspnea [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes27/0 /2020
27 pr 2020 [x]07/05/2020
07 May 2020 [x] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown09 redness [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes2 /0 /2020
2 pr 2020 [x]07/05/2020
07 May 2020 [x] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown0 Cough [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes06/05/2020
06 May 202007:00 [ ]07/05/2020
07 May 2020 [x] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown2Verruca >
operation in
local
anesthesia [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes08/05/2020
08 May 2020 [x]08/05/2020
08 May 2020 [x] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [ ] No [x] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown32 Shivering [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes2/05/2020
2 May 202022:00 [ ]3/05/2020
3 May 2020 [x] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown3 Intermittent
Fe er up to
39 3 degree
C [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes2/05/2020
2 May 202022:00 [ ]/05/2020
May 20209:00 [ ] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [ ] No [x] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown5Malaise [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes2/05/2020
2 May 2020 [x]6/05/2020
6 May 20209:00 [ ] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [ ] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[x] Drug withdrawn
[ ] Not app icable
[ ] Unknown [ ] No [x] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown65 myalgia
(both arms
and legs) [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes2/05/2020
2 May 2020 [x]6/05/2020
6 May 20209:00 [ ] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [ ] No [x] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown76 Injection
s te
reactions
(pa n
tenderness
discomfort
with
movement) [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes25/0 /2020
25 pr 20203:00 [ ]03/05/2020
03 May 202007:00 [ ] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not recovered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Adverse Events (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
58
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057431
Any Comments? [ ] No [x] Yes *
Row Tools Visit Modul Timepoint Comment Date of
Comment
1Visit 7 (a1,
b1, b2)
(EoT)Due to AE study was
early terminated,
therefore visit 7 was
performed earlier.19/05/2020
19-May-2020
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Comments (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
59
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057432
If any grading of any reaction is not NONE and not related to IMP, please document on Adverse Event page.
If any grading of any reaction is not NONE and related to IMP, please document as diagnosis on Adverse Event page.
Row Too sStudy Day
Not
done
Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]24/04/2020
24 Apr 20208: 5 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
22 [ ]25/04/2020
25 Apr 20208: 5 [ ] None
[ ] M d
[ ] Moderate
[x] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[ ] Moderate
[x] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
33 [ ]26/04/2020
26 Apr 20208: 5 [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
44 [ ]27/04/2020
27 Apr 20208: 5 [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
55 [ ]28/04/2020
28 Apr 20208:30 [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
66 [ ]29/04/2020
29 Apr 20208:30 [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
77 [ ]30/04/2020
30 Apr 20208: 5 [ ] None
[x] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[x] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
88 [ ]0 /05/2020
0 May 20208:45 [ ] None
[x] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[x] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Diary - Local Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
60
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057433
99 [ ]02/05/2020
02 May 20209:00 [ ] None
[x] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[x] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Diary - Local Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
61
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057434
f any grading of any reaction is not NONE and not related to MP, or subject has fever [i.e., temperature is >= 38°C], please document on Adverse Event page.
f
any grading of any reaction is not NONE and related to MP, or subject has fever [i.e., temperature is >= 38°C], please document as diagnosis on Adverse Event Page.
Row oolsStudy Day
Not
done
Date ime Body
emperature
( C)Intensity of Headache Intensity of Myalgia
Intens ty of rthralgia Intens ty of Nausea
Intensity of Vom ting
Intensity of Diarrhea
Intens ty of Chils
Intens ty of Loss of appet te
Intensity of Malaise
Intensity of Fatigue
[ ]2 /0 /2020
2 pr 20208: 5 36 2 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
22 [ ]25/0 /2020
25 pr 20208: 5 36 5 [ ] None
[ ] M ld
[ ] Moderate
[x] Se ere
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[ ] Mild
[ ] Moderate
[x] Severe
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[x] Severe
[ ] Potentia ly lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[ ] Moderate
[x] Se ere
[ ] Potentially ife threaten ng
33 [ ]26/0 /2020
26 pr 20208: 5 37 3 [ ] None
[ ] M ld
[ ] Moderate
[x] Se ere
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[ ] Mild
[x] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[x] M ld
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ]27/0 /2020
27 pr 20208: 5 36 5 [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[x] M ld
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[ ] Mild
[x] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[x] M ld
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
55 [ ]28/0 /2020
28 pr 20208:30 36 8 [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[x] M ld
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
66 [ ]29/0 /2020
29 pr 20208:30 36 5 [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[x] M ld
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
77 [ ]30/0 /2020
30 pr 20208: 5 36 8 [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[x] M ld
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
88 [ ]0 /05/2020
0 May 20208: 5 37 5 [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[x] M ld
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[x] M ld
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
99 [ ]02/05/2020
02 May 20209:00 36 5 [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[x] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Diary - Systemic Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
62
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FDA-CBER-2021-5683-0057435
Any Medical History? [x] No [ ] Yes *
If Ongoing, please specify intensity (toxicity grading scale)
Row Tools Abnormality/Disease Start Date End Date Ongoing
1 [ ] No [ ] Yes
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Medical History (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
63
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FDA-CBER-2021-5683-0057436
Row ToolsVaccination
Visit Planned
observation
period Other planned
observation
period (e.g. 8
hours) Adherence to
planned
observation
period? If No, actual
observation
period
(hours)Reason
1Visit 1 24 hours [ ] No [x] Yes
Please insert as many new rows as needed for the according visits!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Observation Period (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
64
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FDA-CBER-2021-5683-0057437
Any prior/concomitant
medication/therapy? [ ] No [x] es *
Row ToolsMedication/Therapy
Taken prior to
Study? Start Date Start Time Start
Time
unkn
End Date End Time End
Time
unkn
Ongoing Route Other route,
specify Individual
dose Unit Other unit,
specify Frequency Other
frequency,
specify Indication AE Nos
Paracetamol [x] No [ ] es25/04/2020
25 Apr 202000 [ ]25/04/2020
25 Apr 202000 [ ] [x] No [ ] esORAL 500 mg ONCE Flu like
symptoms3
2Paracetamol [x] No [ ] es26/04/2020
26 Apr 2020 [x]26/04/2020
26 Apr 2020 [x] [x] No [ ] esORAL 500 mg ONCE Flu like
symptoms3
3Paracetamol [x] No [ ] es02/05/2020
02 May 20208 30 [ ]05/05/2020
05 May 202020 00 [ ] [x] No [ ] esORAL 500 mg OTHER 3x2 Tbl Flu like
symptoms3
4Scandicain
% [x] No [ ] es08/05/2020
08 May 2020 [x]08/05/2020
08 May 2020 [x] [x] No [ ] esSUBCUTANE
OUS30 mg ONCE Verruca
operation in
local
anesthesia
5Ibuprofen [x] No [ ] es2/05/2020
2 May 202023 00 [ ]2/05/2020
2 May 202023 00 [ ] [x] No [ ] esORAL 400 mg ONCE Intermittent
Fever up to
39,3 degree
C3
6Ibuprofen [x] No [ ] es3/05/2020
3 May 202009 00 [ ]6/05/2020
6 May 20209 00 [ ] [x] No [ ] esORAL 400 mg BID Malaise /
Myalgia4 5
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Prior/Concomitant Medication/Therapy (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
65
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FDA-CBER-2021-5683-0057438
Any local/systemic reactions NOT
RELATED to IMP [x] No [ ] Yes *
Row ToolsStudy Day
Date Time Local/systemic
reaction
1
Please insert as many new rows as needed.
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Unrelated Clinical Events (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
66
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FDA-CBER-2021-5683-0057439
Row Too s Date T me Heart Rate
(beats/m n)Interpretat on C n ca
S gn f cance F nd ngs,
select all that
apply
06/05/2020
06 May 202009: 4 6 [x] Norma [ ] Abnorma [ ] NCS [ ] CS
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
67
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FDA-CBER-2021-5683-0057440
[ ]
Row Tools Date Time
119/05/2020
19-May-202009:53
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
68
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FDA-CBER-2021-5683-0057441
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row Tools Date Time Fasting?
106/05/2020
06-May-202009:22 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
69
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057442
Row Tools Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
106/05/2020
06-May-202009:16 Oral 36,1 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
70
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FDA-CBER-2021-5683-0057443
[ ]
Row Too s Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
06/05/2020
06 May 202009:35 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
71
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FDA-CBER-2021-5683-0057444
[ ]
Row Tools Date Time Test name
Result
106/05/2020
06-May-202008:45 On site:
Bosch [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: Oral Swipe for SARS-CoV-2 Testing (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
72
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FDA-CBER-2021-5683-0057445
Date
Time
Overall health judgement -
subject healthy?06/05/2020
06-May-2020
09:36
[ ] No [x] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
11 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
73
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FDA-CBER-2021-5683-0057446
[ ]
Row Tools Date Time
106/05/2020
06-May-202009:00
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:25 (W. Europe Standard Time)
74
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FDA-CBER-2021-5683-0057447
Row oo s Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
106/05/202
0
06 May 202009:15 [x] R g [ ] Lef 120 [ ] NCS [ ] CS 80 [ ] NCS [ ] CS 61 [ ] NCS [ ] CS 12 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0010
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-08-26 14:26 (W. Europe Standard Time)
75
090177e195024bfd\Final\Final On: 25-Sep-2020 01:41 (GMT)
FDA-CBER-2021-5683-0057448