Trial Outcomes & Findings for BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors (NCT NCT04455620)
NCT ID: NCT04455620
Last Updated: 2025-07-02
Results Overview
TERMINATED
PHASE1/PHASE2
49 participants
From first dose of IMP up to 21 days (Cycle 1).
2025-07-02
Participant Flow
The study was conducted at centers experienced in first-in-human studies in two countries, i.e., the US and Spain.
A total of 49 participants were enrolled in this study and all participants received at least one dose of the IMP.
Participant milestones
| Measure |
BNT151 0.4 ug/kg
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the safety review committee (SRC) on Day 1 of every Q3W treatment cycle.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
8
|
24
|
2
|
14
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
8
|
24
|
2
|
14
|
Reasons for withdrawal
| Measure |
BNT151 0.4 ug/kg
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the safety review committee (SRC) on Day 1 of every Q3W treatment cycle.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Death
|
1
|
6
|
20
|
1
|
7
|
|
Overall Study
Study Termination
|
0
|
2
|
1
|
0
|
6
|
Baseline Characteristics
BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
BNT151 0.4 ug/kg
n=1 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
n=8 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
n=24 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
n=2 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
n=14 Participants
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the SRC on Day 1 of every Q3W treatment cycle.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Body mass index (BMI) category
<18 kg/m^2
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Body mass index (BMI) category
≥18 to <25 kg/m^2
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
16 participants
n=10 Participants
|
|
Body mass index (BMI) category
≥25 to <30 kg/m^2
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
17 participants
n=10 Participants
|
|
Body mass index (BMI) category
≥30 kg/m^2
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
15 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From first dose of IMP up to 21 days (Cycle 1).Population: DLT evaluable set, including all participants from the safety set who were enrolled in dose-escalation cohorts and either experienced a DLT during the DLT evaluation period (Cycle 1) or completed the DLT evaluation period. Participants who did not experience any DLT during the DLT observation period were considered to be evaluable if they have been observed for minimum 21 days following the first dose and were considered to have sufficient safety data to conclude that a DLT did not occur.
Outcome measures
| Measure |
BNT151 0.4 ug/kg
n=1 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
n=8 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
n=24 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
n=2 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
n=14 Participants
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the SRC on Day 1 of every Q3W treatment cycle.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) During the DLT Evaluation Period in Part 1
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From first dose of IMP through study completion, a maximum of 30 months.Population: Safety set, i.e., all participants who received IMP (i.e., at least one dose of BNT151).
A TEAE was defined as any adverse event (AE) with an onset date on or after the first administration of IMP (if the AE was absent before the first administration of IMP) or worsened after the first administration of IMP (if the AE was present before the first administration of IMP). AEs with an onset date more than 60 days after the last administration of IMP were considered as treatment emergent only if assessed as related to IMP by the investigator. The intensity of an TEAE was graded according to the NCI CTCAE version 5.0. Grade 3=Severe, Grade 4=Life threatening, Grade 5=Death.
Outcome measures
| Measure |
BNT151 0.4 ug/kg
n=1 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
n=8 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
n=24 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
n=2 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
n=14 Participants
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the SRC on Day 1 of every Q3W treatment cycle.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship
TEAE
|
1 Participants
|
8 Participants
|
24 Participants
|
2 Participants
|
14 Participants
|
|
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship
TEAE related to BNT151
|
0 Participants
|
7 Participants
|
23 Participants
|
2 Participants
|
11 Participants
|
|
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship
Grade ≥3 TEAE
|
1 Participants
|
3 Participants
|
14 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship
Grade ≥3 TEAE related to BNT151
|
0 Participants
|
3 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship
TEAE related to study procedure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship
Serious TEAE
|
0 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship
Serious TEAE related to BNT151
|
0 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship
Serious TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) Including Grade ≥3, Serious, Fatal TEAE by Relationship
Serious TEAE related to BNT151 leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of IMP through treatment completion, a maximum of 24 months.Population: Safety set, i.e., all participants who received IMP (i.e., at least one dose of BNT151).
A TEAE was defined as any AE with an onset date on or after the first administration of IMP (if the AE was absent before the first administration of IMP) or worsened after the first administration of IMP (if the AE was present before the first administration of IMP). AEs with an onset date more than 60 days after the last administration of IMP were considered as treatment emergent only if assessed as related to IMP by the investigator.
Outcome measures
| Measure |
BNT151 0.4 ug/kg
n=1 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
n=8 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
n=24 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
n=2 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
n=14 Participants
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the SRC on Day 1 of every Q3W treatment cycle.
|
|---|---|---|---|---|---|
|
Number of Paticipants With at Least One TEAE Leading to Dose Reduction, Dose Interruption, and Treatment Discontinuation of BNT151
TEAE leading to dose reduction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Paticipants With at Least One TEAE Leading to Dose Reduction, Dose Interruption, and Treatment Discontinuation of BNT151
TEAE leading to dose interruption
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Paticipants With at Least One TEAE Leading to Dose Reduction, Dose Interruption, and Treatment Discontinuation of BNT151
TEAE leading to permanent treatment discontinuation of BNT151
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion, a maximum of 30 months.Population: Treated set, i.e., defined as all participants who received IMP (i.e., at least one dose of BNT151).
ORR was defined as the proportion of participants in whom a complete response (CR) or partial response (PR) (per RECIST version 1.1) was observed as best overall response. Confirmed ORR was defined as the proportion of participants in whom a CR or PR (per RECIST version 1.1) was observed as best overall response and has been confirmed with a subsequent assessment of objective response at least 4 weeks apart.
Outcome measures
| Measure |
BNT151 0.4 ug/kg
n=1 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
n=8 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
n=24 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
n=2 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
n=14 Participants
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the SRC on Day 1 of every Q3W treatment cycle.
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
ORR
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 36.9
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
0 percentage of participants
Interval 0.0 to 84.2
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
|
Objective Response Rate (ORR)
Confirmed ORR
|
0 percentage of participants
Interval 0.0 to 97.5
|
0 percentage of participants
Interval 0.0 to 36.9
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
0 percentage of participants
Interval 0.0 to 84.2
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
SECONDARY outcome
Timeframe: Through study completion, a maximum of 30 months.Population: Treated set, i.e., defined as all participants who received IMP (i.e., at least one dose of BNT151).
DCR was defined as the proportion of participants in whom a CR or PR or stable disease (SD) (per RECIST version 1.1, SD assessed at least 6 weeks after first dose) was observed as best overall response.
Outcome measures
| Measure |
BNT151 0.4 ug/kg
n=1 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
n=8 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
n=24 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
n=2 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
n=14 Participants
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the SRC on Day 1 of every Q3W treatment cycle.
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
0 percentage of partients
Interval 0.0 to 97.5
|
25 percentage of partients
Interval 3.2 to 65.1
|
25 percentage of partients
Interval 9.8 to 46.7
|
0 percentage of partients
Interval 0.0 to 84.2
|
42.9 percentage of partients
Interval 17.7 to 71.1
|
SECONDARY outcome
Timeframe: Through study completion, a maximum of 30 months.Population: Treated set, i.e., defined as all participants who received IMP (i.e., at least one dose of BNT151).
DOR was defined as the time from first objective response (CR or PR per RECIST version 1.1) to first occurrence of objective tumor progression (progressive disease per RECIST version 1.1) or death from any cause, whichever occurred first. Reporting groups with zero participants with confirmed objective response are not included.
Outcome measures
| Measure |
BNT151 0.4 ug/kg
n=1 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
n=1 Participants
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the SRC on Day 1 of every Q3W treatment cycle.
|
|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
6.5 months
Confidence interval values value could not be estimated.
|
NA months
Value could not be calculated because participant was censored as per SAP defined censoring rules (i.e., no progression / lost to follow up).
|
—
|
—
|
—
|
Adverse Events
BNT151 0.4 ug/kg
BNT151 2.0 ug/kg
BNT151 4.0 ug/kg
BNT151 8.0 ug/kg
BNT151 2.0 + 4.0 ug/kg
Serious adverse events
| Measure |
BNT151 0.4 ug/kg
n=1 participants at risk
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
n=8 participants at risk
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
n=24 participants at risk
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
n=2 participants at risk
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
n=14 participants at risk
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the SRC on Day 1 of every Q3W treatment cycle.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
16.7%
4/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
Other adverse events
| Measure |
BNT151 0.4 ug/kg
n=1 participants at risk
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 ug/kg
n=8 participants at risk
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 4.0 ug/kg
n=24 participants at risk
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 8.0 ug/kg
n=2 participants at risk
Participants from Part 1 treated with BNT151 monotherapy. BNT151 was administered intravenously on Day 1 of each 3-week treatment cycle (Q3W; 21 days).
|
BNT151 2.0 + 4.0 ug/kg
n=14 participants at risk
Participants from Part 1 treated with BNT151 monotherapy with pre-conditioning. Treatment started with a pre-conditioning dose (a lower dose of 2 μg/kg) on Day 1 of the pre-conditioning cycle (cycle of 7 days). The participants then received the intended dose of 4 μg/kg at the discretion of the SRC on Day 1 of every Q3W treatment cycle.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
20.8%
5/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
25.0%
2/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
29.2%
7/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
16.7%
4/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
21.4%
3/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Chills
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
3/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
21.4%
3/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
25.0%
2/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
3/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
35.7%
5/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Pain
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
25.0%
6/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
14.3%
2/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
3/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
3/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
25.0%
2/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
37.5%
9/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
71.4%
10/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
25.0%
2/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
37.5%
3/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
Blood alkaline phosphatase increased
|
100.0%
1/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
3/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
16.7%
4/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
14.3%
2/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
4/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
12/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
3/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Investigations
White blood cell count increased
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
20.8%
5/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
25.0%
2/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
3/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
14.3%
2/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
25.0%
2/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
14.3%
2/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Renal and urinary disorders
Choluria
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
25.0%
2/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
14.3%
2/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
14.3%
2/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
1/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
25.0%
2/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
45.8%
11/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
21.4%
3/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
3/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Eye disorders
Keratitis
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Eye disorders
Visual impairment
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
4.2%
1/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
14.3%
2/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
8.3%
2/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
50.0%
1/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
12.5%
1/8 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
20.8%
5/24 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
0.00%
0/2 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
7.1%
1/14 • Deaths and serious AEs: All events from the signing of the study-specific ICF until early study termination, i.e., up to 31 months. Other AEs: All TEAEs, i.e., AEs reported from the start of study drug treatment until until early study termination, i.e., up to 30 months.
Other AEs: All TEAEs, i.e., any AE with an onset date on or after the first dose of BNT151 (if the AE was absent before the first dose) or worsened after the first dose of BNT151 (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of BNT151 were included only if assessed as related to BNT151 by the investigator. If a participant experienced more than one event in a category, the participant is counted only once in that category.
|
Additional Information
BioNTech clinical trials patient information
BioNTech SE
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators respectively study sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER